Trial Outcomes & Findings for An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease (NCT NCT00790933)
NCT ID: NCT00790933
Last Updated: 2022-05-24
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2243 participants
Primary outcome timeframe
From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
Results posted on
2022-05-24
Participant Flow
Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.
Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).
Participant milestones
| Measure |
Vedolizumab 300 mg (C13006)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13007)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13011)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13004)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
|
Vedolizumab 300 mg (C13008 De Novo Participants)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
675
|
726
|
384
|
37
|
421
|
|
Overall Study
COMPLETED
|
237
|
246
|
115
|
23
|
145
|
|
Overall Study
NOT COMPLETED
|
438
|
480
|
269
|
14
|
276
|
Reasons for withdrawal
| Measure |
Vedolizumab 300 mg (C13006)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13007)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13011)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13004)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
|
Vedolizumab 300 mg (C13008 De Novo Participants)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
94
|
119
|
65
|
5
|
69
|
|
Overall Study
Protocol Violation(s)
|
8
|
18
|
7
|
0
|
12
|
|
Overall Study
Lack of Efficacy
|
192
|
176
|
130
|
1
|
121
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
123
|
120
|
52
|
6
|
50
|
|
Overall Study
Lost to Follow-up
|
13
|
31
|
10
|
1
|
15
|
|
Overall Study
Reason Not Specified
|
8
|
16
|
4
|
1
|
9
|
Baseline Characteristics
BMI was not calculated for de novo participants due to no collection of height information.
Baseline characteristics by cohort
| Measure |
Vedolizumab 300 mg (C13006)
n=675 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13007)
n=726 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
|
Vedolizumab 300 mg (C13011)
n=384 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13004)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
|
Vedolizumab 300 mg (C13008 De Novo Participants)
n=421 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study.
|
Total
n=2243 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
1 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
3 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
Asian
|
98 Participants
n=675 Participants
|
66 Participants
n=726 Participants
|
14 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
9 Participants
n=421 Participants
|
187 Participants
n=2243 Participants
|
|
Age, Continuous
|
41.2 years
STANDARD_DEVIATION 13.27 • n=675 Participants
|
37.3 years
STANDARD_DEVIATION 12.26 • n=726 Participants
|
38.3 years
STANDARD_DEVIATION 12.87 • n=384 Participants
|
43.9 years
STANDARD_DEVIATION 14.24 • n=37 Participants
|
39.3 years
STANDARD_DEVIATION 14.23 • n=421 Participants
|
39.1 years
STANDARD_DEVIATION 13.19 • n=2243 Participants
|
|
Age, Customized
<65
|
646 Participants
n=675 Participants
|
710 Participants
n=726 Participants
|
376 Participants
n=384 Participants
|
35 Participants
n=37 Participants
|
400 Participants
n=421 Participants
|
2167 Participants
n=2243 Participants
|
|
Age, Customized
>=65
|
29 Participants
n=675 Participants
|
16 Participants
n=726 Participants
|
8 Participants
n=384 Participants
|
2 Participants
n=37 Participants
|
21 Participants
n=421 Participants
|
76 Participants
n=2243 Participants
|
|
Sex: Female, Male
Female
|
280 Participants
n=675 Participants
|
384 Participants
n=726 Participants
|
216 Participants
n=384 Participants
|
20 Participants
n=37 Participants
|
215 Participants
n=421 Participants
|
1115 Participants
n=2243 Participants
|
|
Sex: Female, Male
Male
|
395 Participants
n=675 Participants
|
342 Participants
n=726 Participants
|
168 Participants
n=384 Participants
|
17 Participants
n=37 Participants
|
206 Participants
n=421 Participants
|
1128 Participants
n=2243 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=675 Participants
|
12 Participants
n=726 Participants
|
7 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
19 Participants
n=421 Participants
|
67 Participants
n=2243 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
631 Participants
n=675 Participants
|
700 Participants
n=726 Participants
|
372 Participants
n=384 Participants
|
36 Participants
n=37 Participants
|
400 Participants
n=421 Participants
|
2139 Participants
n=2243 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=675 Participants
|
14 Participants
n=726 Participants
|
5 Participants
n=384 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=421 Participants
|
37 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
White
|
557 Participants
n=675 Participants
|
641 Participants
n=726 Participants
|
349 Participants
n=384 Participants
|
36 Participants
n=37 Participants
|
398 Participants
n=421 Participants
|
1981 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=675 Participants
|
17 Participants
n=726 Participants
|
7 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
8 Participants
n=421 Participants
|
42 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
2 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
1 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
3 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=675 Participants
|
2 Participants
n=726 Participants
|
11 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
5 Participants
n=421 Participants
|
24 Participants
n=2243 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
2 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=421 Participants
|
3 Participants
n=2243 Participants
|
|
Region of Enrollment
Australia
|
41 Participants
n=675 Participants
|
30 Participants
n=726 Participants
|
8 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
21 Participants
n=421 Participants
|
100 Participants
n=2243 Participants
|
|
Region of Enrollment
Hong Kong
|
1 Participants
n=675 Participants
|
2 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
3 Participants
n=2243 Participants
|
|
Region of Enrollment
India
|
39 Participants
n=675 Participants
|
24 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
63 Participants
n=2243 Participants
|
|
Region of Enrollment
Malaysia
|
8 Participants
n=675 Participants
|
6 Participants
n=726 Participants
|
3 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
17 Participants
n=2243 Participants
|
|
Region of Enrollment
New Zealand
|
9 Participants
n=675 Participants
|
8 Participants
n=726 Participants
|
1 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
8 Participants
n=421 Participants
|
26 Participants
n=2243 Participants
|
|
Region of Enrollment
Singapore
|
1 Participants
n=675 Participants
|
1 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
2 Participants
n=2243 Participants
|
|
Region of Enrollment
South Africa
|
13 Participants
n=675 Participants
|
15 Participants
n=726 Participants
|
8 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
36 Participants
n=2243 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
34 Participants
n=675 Participants
|
18 Participants
n=726 Participants
|
7 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
59 Participants
n=2243 Participants
|
|
Region of Enrollment
Taiwan, Province Of China
|
1 Participants
n=675 Participants
|
3 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
4 Participants
n=2243 Participants
|
|
Region of Enrollment
Czech Republic
|
34 Participants
n=675 Participants
|
67 Participants
n=726 Participants
|
36 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
69 Participants
n=421 Participants
|
206 Participants
n=2243 Participants
|
|
Region of Enrollment
Greece
|
5 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
5 Participants
n=2243 Participants
|
|
Region of Enrollment
Hungary
|
12 Participants
n=675 Participants
|
47 Participants
n=726 Participants
|
22 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
17 Participants
n=421 Participants
|
98 Participants
n=2243 Participants
|
|
Region of Enrollment
Poland
|
53 Participants
n=675 Participants
|
20 Participants
n=726 Participants
|
9 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
82 Participants
n=2243 Participants
|
|
Region of Enrollment
Romania
|
0 Participants
n=675 Participants
|
4 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
4 Participants
n=2243 Participants
|
|
Region of Enrollment
Serbia
|
0 Participants
n=675 Participants
|
2 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
2 Participants
n=2243 Participants
|
|
Region of Enrollment
Slovakia
|
0 Participants
n=675 Participants
|
14 Participants
n=726 Participants
|
17 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
31 Participants
n=2243 Participants
|
|
Region of Enrollment
Bulgaria
|
5 Participants
n=675 Participants
|
6 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
11 Participants
n=2243 Participants
|
|
Region of Enrollment
Estonia
|
9 Participants
n=675 Participants
|
5 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
14 Participants
n=2243 Participants
|
|
Region of Enrollment
Israel
|
2 Participants
n=675 Participants
|
12 Participants
n=726 Participants
|
21 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
21 Participants
n=421 Participants
|
56 Participants
n=2243 Participants
|
|
Region of Enrollment
Latvia
|
0 Participants
n=675 Participants
|
1 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
1 Participants
n=2243 Participants
|
|
Region of Enrollment
Russia
|
46 Participants
n=675 Participants
|
24 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
15 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
85 Participants
n=2243 Participants
|
|
Region of Enrollment
Turkey
|
6 Participants
n=675 Participants
|
3 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
9 Participants
n=2243 Participants
|
|
Region of Enrollment
Ukraine
|
0 Participants
n=675 Participants
|
9 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
9 Participants
n=2243 Participants
|
|
Region of Enrollment
Canada
|
73 Participants
n=675 Participants
|
98 Participants
n=726 Participants
|
75 Participants
n=384 Participants
|
22 Participants
n=37 Participants
|
87 Participants
n=421 Participants
|
355 Participants
n=2243 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=675 Participants
|
166 Participants
n=726 Participants
|
109 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
147 Participants
n=421 Participants
|
591 Participants
n=2243 Participants
|
|
Region of Enrollment
Austria
|
13 Participants
n=675 Participants
|
9 Participants
n=726 Participants
|
3 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
25 Participants
n=2243 Participants
|
|
Region of Enrollment
Belgium
|
48 Participants
n=675 Participants
|
48 Participants
n=726 Participants
|
33 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
46 Participants
n=421 Participants
|
175 Participants
n=2243 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
2 Participants
n=2243 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=675 Participants
|
25 Participants
n=726 Participants
|
10 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
46 Participants
n=2243 Participants
|
|
Region of Enrollment
Germany
|
10 Participants
n=675 Participants
|
25 Participants
n=726 Participants
|
4 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
5 Participants
n=421 Participants
|
44 Participants
n=2243 Participants
|
|
Region of Enrollment
Iceland
|
3 Participants
n=675 Participants
|
3 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
6 Participants
n=2243 Participants
|
|
Region of Enrollment
Ireland
|
1 Participants
n=675 Participants
|
1 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
2 Participants
n=2243 Participants
|
|
Region of Enrollment
Italy
|
12 Participants
n=675 Participants
|
7 Participants
n=726 Participants
|
4 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
23 Participants
n=2243 Participants
|
|
Region of Enrollment
Netherlands
|
2 Participants
n=675 Participants
|
5 Participants
n=726 Participants
|
12 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
19 Participants
n=2243 Participants
|
|
Region of Enrollment
Norway
|
7 Participants
n=675 Participants
|
5 Participants
n=726 Participants
|
2 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
14 Participants
n=2243 Participants
|
|
Region of Enrollment
Spain
|
1 Participants
n=675 Participants
|
4 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
5 Participants
n=2243 Participants
|
|
Region of Enrollment
Sweden
|
0 Participants
n=675 Participants
|
5 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
5 Participants
n=2243 Participants
|
|
Region of Enrollment
Switzerland
|
2 Participants
n=675 Participants
|
4 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
6 Participants
n=2243 Participants
|
|
Region of Enrollment
United Kingdom
|
2 Participants
n=675 Participants
|
0 Participants
n=726 Participants
|
0 Participants
n=384 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=421 Participants
|
2 Participants
n=2243 Participants
|
|
Body Weight
|
74.10 kg
STANDARD_DEVIATION 17.934 • n=675 Participants
|
71.70 kg
STANDARD_DEVIATION 19.600 • n=726 Participants
|
71.29 kg
STANDARD_DEVIATION 18.951 • n=384 Participants
|
77.66 kg
STANDARD_DEVIATION 18.907 • n=37 Participants
|
75.45 kg
STANDARD_DEVIATION 18.814 • n=421 Participants
|
73.15 kg
STANDARD_DEVIATION 18.900 • n=2243 Participants
|
|
BMI
|
25.39 kg/m^2
STANDARD_DEVIATION 5.391 • n=675 Participants • BMI was not calculated for de novo participants due to no collection of height information.
|
24.61 kg/m^2
STANDARD_DEVIATION 6.039 • n=726 Participants • BMI was not calculated for de novo participants due to no collection of height information.
|
24.56 kg/m^2
STANDARD_DEVIATION 5.783 • n=384 Participants • BMI was not calculated for de novo participants due to no collection of height information.
|
27.11 kg/m^2
STANDARD_DEVIATION 6.523 • n=37 Participants • BMI was not calculated for de novo participants due to no collection of height information.
|
—
|
24.94 kg/m^2
STANDARD_DEVIATION 5.779 • n=1822 Participants • BMI was not calculated for de novo participants due to no collection of height information.
|
PRIMARY outcome
Timeframe: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=894 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1349 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
93 percentage of participants
|
96 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
31 percentage of participants
|
41 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin \<= 70 g/L, absolute lymphocyte count \<0.5 X 10\^9/L, leukocytes \<2.0 X 10\^9/L (absolute value), platelets \<75.0 X 10\^9/L, absolute neutrophil Count \<1.0 X 10\^9/L, prothrombin time \>1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) \>3.0 x ULN, aspartate aminotransferase (AST) \>3.0 x ULN, bilirubin \>2.0 x ULN, amylase \>2.0 x ULN, lipase \>2.0 x ULN.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=894 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1349 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Hemoglobin <= 70 g/L
|
16 participants
|
11 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Absolute Lymphocyte Count <0.5 X 10^9/L
|
28 participants
|
56 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Leukocytes <2.0 X 10^9/L (Absolute Value)
|
1 participants
|
3 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Platelets <75.0 X 10^9/L
|
2 participants
|
5 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Absolute Neutrophil Count <1.0 X 10^9/L
|
9 participants
|
9 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Prothrombin Time >1.25 x ULN
|
42 participants
|
37 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
ALT >3.0 x ULN
|
30 participants
|
47 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
AST >3.0 x ULN
|
35 participants
|
34 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Bilirubin >2.0 x ULN
|
12 participants
|
14 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Amylase >2.0 x ULN
|
16 participants
|
36 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Markedly Abnormal Safety Laboratory Findings
Lipase >2.0 x ULN
|
27 participants
|
41 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=894 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1349 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=894 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1349 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
|
7 participants
|
7 participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)Population: Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement.
IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=2142 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
IBD-related events, UC
|
NA weeks
Median was not estimable due to the low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
IBD-related events, CD
|
NA weeks
Median was not estimable due to the low number of participants with events.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28Population: Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=67 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=52 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=127 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=134 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=150 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=161 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
Baseline
|
125.34 score on a scale
Standard Deviation 34.895
|
129.12 score on a scale
Standard Deviation 34.289
|
124.37 score on a scale
Standard Deviation 31.632
|
122.33 score on a scale
Standard Deviation 31.114
|
127.56 score on a scale
Standard Deviation 33.718
|
127.11 score on a scale
Standard Deviation 30.537
|
123.88 score on a scale
Standard Deviation 31.620
|
124.35 score on a scale
Standard Deviation 33.310
|
131.44 score on a scale
Standard Deviation 27.715
|
132.14 score on a scale
Standard Deviation 32.245
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
Change at Week 28
|
60.00 score on a scale
Standard Deviation 41.165
|
62.71 score on a scale
Standard Deviation 34.600
|
62.53 score on a scale
Standard Deviation 35.072
|
57.17 score on a scale
Standard Deviation 38.851
|
57.52 score on a scale
Standard Deviation 42.561
|
51.48 score on a scale
Standard Deviation 34.576
|
41.71 score on a scale
Standard Deviation 36.508
|
40.49 score on a scale
Standard Deviation 39.733
|
42.90 score on a scale
Standard Deviation 32.581
|
30.84 score on a scale
Standard Deviation 34.614
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=65 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=56 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=107 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=117 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=132 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=134 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
Baseline
|
123.53 score on a scale
Standard Deviation 36.160
|
131.17 score on a scale
Standard Deviation 33.675
|
125.03 score on a scale
Standard Deviation 32.560
|
120.29 score on a scale
Standard Deviation 30.894
|
129.46 score on a scale
Standard Deviation 34.799
|
128.69 score on a scale
Standard Deviation 30.461
|
125.30 score on a scale
Standard Deviation 30.075
|
125.31 score on a scale
Standard Deviation 34.140
|
130.63 score on a scale
Standard Deviation 28.446
|
132.71 score on a scale
Standard Deviation 33.108
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
Change at Week 52
|
66.84 score on a scale
Standard Deviation 41.733
|
59.89 score on a scale
Standard Deviation 33.170
|
61.06 score on a scale
Standard Deviation 37.386
|
59.31 score on a scale
Standard Deviation 34.837
|
58.87 score on a scale
Standard Deviation 40.707
|
52.30 score on a scale
Standard Deviation 29.385
|
44.31 score on a scale
Standard Deviation 37.923
|
47.38 score on a scale
Standard Deviation 37.687
|
47.07 score on a scale
Standard Deviation 30.463
|
37.33 score on a scale
Standard Deviation 40.232
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=55 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=91 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=106 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=118 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=113 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
Baseline
|
123.66 score on a scale
Standard Deviation 36.115
|
131.31 score on a scale
Standard Deviation 33.726
|
123.87 score on a scale
Standard Deviation 31.752
|
120.00 score on a scale
Standard Deviation 29.667
|
128.47 score on a scale
Standard Deviation 34.724
|
129.06 score on a scale
Standard Deviation 31.694
|
124.89 score on a scale
Standard Deviation 31.629
|
125.89 score on a scale
Standard Deviation 34.478
|
130.75 score on a scale
Standard Deviation 28.587
|
132.46 score on a scale
Standard Deviation 33.245
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
Change at Week 76
|
65.53 score on a scale
Standard Deviation 40.584
|
59.88 score on a scale
Standard Deviation 35.290
|
64.27 score on a scale
Standard Deviation 32.443
|
59.91 score on a scale
Standard Deviation 34.449
|
55.05 score on a scale
Standard Deviation 47.181
|
52.85 score on a scale
Standard Deviation 36.486
|
47.43 score on a scale
Standard Deviation 35.811
|
46.32 score on a scale
Standard Deviation 36.397
|
50.59 score on a scale
Standard Deviation 30.794
|
40.14 score on a scale
Standard Deviation 39.305
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=55 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=84 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=96 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=112 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=104 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
Baseline
|
124.70 score on a scale
Standard Deviation 37.614
|
130.90 score on a scale
Standard Deviation 34.361
|
124.52 score on a scale
Standard Deviation 30.033
|
120.89 score on a scale
Standard Deviation 29.745
|
129.53 score on a scale
Standard Deviation 35.261
|
128.25 score on a scale
Standard Deviation 32.333
|
123.50 score on a scale
Standard Deviation 29.662
|
128.35 score on a scale
Standard Deviation 33.793
|
132.41 score on a scale
Standard Deviation 28.538
|
132.48 score on a scale
Standard Deviation 32.305
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
Change at Week 100
|
61.83 score on a scale
Standard Deviation 41.505
|
62.46 score on a scale
Standard Deviation 32.502
|
62.83 score on a scale
Standard Deviation 34.475
|
57.04 score on a scale
Standard Deviation 38.448
|
58.53 score on a scale
Standard Deviation 45.644
|
53.40 score on a scale
Standard Deviation 32.651
|
49.89 score on a scale
Standard Deviation 36.806
|
46.95 score on a scale
Standard Deviation 34.691
|
52.50 score on a scale
Standard Deviation 32.267
|
38.52 score on a scale
Standard Deviation 36.982
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=82 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=95 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=97 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
Baseline
|
127.33 score on a scale
Standard Deviation 36.470
|
130.83 score on a scale
Standard Deviation 34.399
|
123.65 score on a scale
Standard Deviation 30.180
|
119.77 score on a scale
Standard Deviation 29.963
|
132.36 score on a scale
Standard Deviation 34.573
|
130.01 score on a scale
Standard Deviation 33.454
|
122.91 score on a scale
Standard Deviation 29.869
|
129.08 score on a scale
Standard Deviation 33.576
|
132.75 score on a scale
Standard Deviation 28.131
|
131.56 score on a scale
Standard Deviation 31.567
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
Change at Week 124
|
63.94 score on a scale
Standard Deviation 44.480
|
60.94 score on a scale
Standard Deviation 37.769
|
63.71 score on a scale
Standard Deviation 34.542
|
61.91 score on a scale
Standard Deviation 36.288
|
53.91 score on a scale
Standard Deviation 44.023
|
53.74 score on a scale
Standard Deviation 34.514
|
46.62 score on a scale
Standard Deviation 38.435
|
47.60 score on a scale
Standard Deviation 40.634
|
54.47 score on a scale
Standard Deviation 29.636
|
40.35 score on a scale
Standard Deviation 41.543
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=93 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=92 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
Baseline
|
127.33 score on a scale
Standard Deviation 36.470
|
131.95 score on a scale
Standard Deviation 34.649
|
123.02 score on a scale
Standard Deviation 29.685
|
119.07 score on a scale
Standard Deviation 30.344
|
132.23 score on a scale
Standard Deviation 35.877
|
130.25 score on a scale
Standard Deviation 34.108
|
122.01 score on a scale
Standard Deviation 28.967
|
128.66 score on a scale
Standard Deviation 34.624
|
133.36 score on a scale
Standard Deviation 28.616
|
132.38 score on a scale
Standard Deviation 32.172
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
Change at Week 148
|
60.66 score on a scale
Standard Deviation 41.786
|
62.72 score on a scale
Standard Deviation 33.786
|
65.81 score on a scale
Standard Deviation 33.232
|
60.41 score on a scale
Standard Deviation 36.074
|
54.53 score on a scale
Standard Deviation 48.036
|
56.08 score on a scale
Standard Deviation 32.954
|
52.30 score on a scale
Standard Deviation 39.123
|
49.40 score on a scale
Standard Deviation 36.880
|
54.50 score on a scale
Standard Deviation 32.874
|
42.13 score on a scale
Standard Deviation 40.030
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=24 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=89 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
Baseline
|
130.25 score on a scale
Standard Deviation 36.650
|
132.93 score on a scale
Standard Deviation 34.216
|
123.47 score on a scale
Standard Deviation 30.141
|
120.49 score on a scale
Standard Deviation 30.221
|
131.60 score on a scale
Standard Deviation 36.013
|
132.31 score on a scale
Standard Deviation 33.860
|
120.70 score on a scale
Standard Deviation 27.535
|
127.42 score on a scale
Standard Deviation 34.779
|
133.34 score on a scale
Standard Deviation 28.981
|
131.69 score on a scale
Standard Deviation 32.229
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
Change at Week 172
|
58.67 score on a scale
Standard Deviation 42.513
|
62.20 score on a scale
Standard Deviation 33.187
|
62.16 score on a scale
Standard Deviation 33.969
|
65.43 score on a scale
Standard Deviation 35.350
|
54.91 score on a scale
Standard Deviation 40.758
|
53.92 score on a scale
Standard Deviation 33.132
|
51.55 score on a scale
Standard Deviation 40.714
|
47.97 score on a scale
Standard Deviation 35.121
|
56.02 score on a scale
Standard Deviation 33.863
|
41.18 score on a scale
Standard Deviation 40.805
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=50 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=66 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=51 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
Baseline
|
127.33 score on a scale
Standard Deviation 36.470
|
135.33 score on a scale
Standard Deviation 33.596
|
122.00 score on a scale
Standard Deviation 30.129
|
119.35 score on a scale
Standard Deviation 31.651
|
130.39 score on a scale
Standard Deviation 36.410
|
132.16 score on a scale
Standard Deviation 34.217
|
121.15 score on a scale
Standard Deviation 28.703
|
126.44 score on a scale
Standard Deviation 34.826
|
136.55 score on a scale
Standard Deviation 27.551
|
137.27 score on a scale
Standard Deviation 30.844
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
Change at Week 196
|
63.19 score on a scale
Standard Deviation 38.061
|
59.13 score on a scale
Standard Deviation 33.318
|
68.89 score on a scale
Standard Deviation 34.578
|
64.81 score on a scale
Standard Deviation 36.563
|
58.90 score on a scale
Standard Deviation 46.107
|
55.67 score on a scale
Standard Deviation 32.453
|
52.22 score on a scale
Standard Deviation 42.363
|
49.41 score on a scale
Standard Deviation 35.662
|
49.05 score on a scale
Standard Deviation 30.390
|
36.35 score on a scale
Standard Deviation 41.424
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=36 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
Baseline
|
116.05 score on a scale
Standard Deviation 31.747
|
133.61 score on a scale
Standard Deviation 32.538
|
120.28 score on a scale
Standard Deviation 30.875
|
116.63 score on a scale
Standard Deviation 32.888
|
131.81 score on a scale
Standard Deviation 35.906
|
129.37 score on a scale
Standard Deviation 31.455
|
122.00 score on a scale
Standard Deviation 27.231
|
125.93 score on a scale
Standard Deviation 35.080
|
127.00 score on a scale
Standard Deviation 63.930
|
128.00 score on a scale
Standard Deviation 35.749
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
Change at Week 248
|
76.21 score on a scale
Standard Deviation 38.693
|
57.52 score on a scale
Standard Deviation 31.841
|
69.56 score on a scale
Standard Deviation 38.680
|
65.72 score on a scale
Standard Deviation 34.776
|
54.97 score on a scale
Standard Deviation 41.658
|
58.76 score on a scale
Standard Deviation 35.250
|
51.39 score on a scale
Standard Deviation 45.950
|
53.04 score on a scale
Standard Deviation 38.830
|
73.00 score on a scale
Standard Deviation 48.446
|
72.00 score on a scale
Standard Deviation 32.156
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=7 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=14 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=13 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=9 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=8 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
Baseline
|
100.71 score on a scale
Standard Deviation 21.831
|
137.50 score on a scale
Standard Deviation 30.478
|
120.38 score on a scale
Standard Deviation 24.401
|
119.67 score on a scale
Standard Deviation 33.463
|
134.88 score on a scale
Standard Deviation 36.957
|
121.38 score on a scale
Standard Deviation 30.133
|
120.25 score on a scale
Standard Deviation 19.085
|
162.50 score on a scale
Standard Deviation 47.376
|
—
|
—
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
Change at Week 300
|
94.29 score on a scale
Standard Deviation 38.612
|
55.43 score on a scale
Standard Deviation 41.694
|
67.54 score on a scale
Standard Deviation 27.823
|
69.00 score on a scale
Standard Deviation 41.192
|
53.00 score on a scale
Standard Deviation 41.542
|
72.00 score on a scale
Standard Deviation 35.219
|
73.50 score on a scale
Standard Deviation 12.342
|
2.00 score on a scale
Standard Deviation 5.657
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
Baseline
|
89.00 score on a scale
Standard Deviation NA
Standard deviation (SD) was not calculated for 1 participant.
|
120.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
118.00 score on a scale
Standard Deviation 32.047
|
70.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
137.00 score on a scale
Standard Deviation 28.284
|
126.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
Change at Week 352
|
123.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
86.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
66.00 score on a scale
Standard Deviation 33.181
|
131.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
37.50 score on a scale
Standard Deviation 28.991
|
84.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=67 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=52 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=127 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=136 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=151 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=162 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
Baseline
|
39.57 score on a scale
Standard Deviation 8.599
|
41.15 score on a scale
Standard Deviation 8.313
|
40.05 score on a scale
Standard Deviation 7.634
|
37.05 score on a scale
Standard Deviation 7.522
|
37.87 score on a scale
Standard Deviation 8.113
|
39.09 score on a scale
Standard Deviation 7.771
|
37.92 score on a scale
Standard Deviation 8.355
|
36.81 score on a scale
Standard Deviation 8.274
|
40.06 score on a scale
Standard Deviation 8.631
|
39.20 score on a scale
Standard Deviation 7.306
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
Change at Week 28
|
10.20 score on a scale
Standard Deviation 8.792
|
8.22 score on a scale
Standard Deviation 9.015
|
8.89 score on a scale
Standard Deviation 7.110
|
9.85 score on a scale
Standard Deviation 8.789
|
12.46 score on a scale
Standard Deviation 8.900
|
9.60 score on a scale
Standard Deviation 7.620
|
6.48 score on a scale
Standard Deviation 8.514
|
7.74 score on a scale
Standard Deviation 9.310
|
7.07 score on a scale
Standard Deviation 8.752
|
5.67 score on a scale
Standard Deviation 7.695
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=67 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=52 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=127 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=136 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=151 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=162 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
Baseline
|
39.98 score on a scale
Standard Deviation 11.349
|
40.70 score on a scale
Standard Deviation 11.226
|
38.28 score on a scale
Standard Deviation 11.039
|
35.49 score on a scale
Standard Deviation 11.139
|
38.53 score on a scale
Standard Deviation 10.631
|
37.70 score on a scale
Standard Deviation 12.423
|
36.60 score on a scale
Standard Deviation 11.545
|
38.04 score on a scale
Standard Deviation 12.567
|
40.87 score on a scale
Standard Deviation 11.385
|
39.29 score on a scale
Standard Deviation 11.535
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
Change at Week 28
|
8.36 score on a scale
Standard Deviation 13.096
|
11.10 score on a scale
Standard Deviation 11.098
|
11.52 score on a scale
Standard Deviation 12.464
|
13.35 score on a scale
Standard Deviation 11.857
|
10.88 score on a scale
Standard Deviation 12.396
|
10.94 score on a scale
Standard Deviation 12.386
|
7.48 score on a scale
Standard Deviation 12.061
|
6.34 score on a scale
Standard Deviation 13.161
|
6.48 score on a scale
Standard Deviation 10.809
|
3.72 score on a scale
Standard Deviation 12.377
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=64 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=69 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=56 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=107 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=118 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=133 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=135 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
Baseline
|
39.94 score on a scale
Standard Deviation 8.930
|
41.72 score on a scale
Standard Deviation 8.314
|
40.12 score on a scale
Standard Deviation 7.694
|
36.75 score on a scale
Standard Deviation 7.510
|
37.82 score on a scale
Standard Deviation 8.301
|
39.23 score on a scale
Standard Deviation 7.807
|
37.87 score on a scale
Standard Deviation 7.992
|
37.40 score on a scale
Standard Deviation 8.171
|
40.51 score on a scale
Standard Deviation 8.454
|
39.27 score on a scale
Standard Deviation 7.469
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
Change at Week 52
|
9.55 score on a scale
Standard Deviation 10.155
|
8.57 score on a scale
Standard Deviation 7.889
|
9.77 score on a scale
Standard Deviation 6.766
|
9.43 score on a scale
Standard Deviation 9.088
|
12.97 score on a scale
Standard Deviation 9.147
|
9.98 score on a scale
Standard Deviation 7.824
|
7.48 score on a scale
Standard Deviation 8.800
|
8.97 score on a scale
Standard Deviation 8.743
|
8.37 score on a scale
Standard Deviation 8.401
|
6.72 score on a scale
Standard Deviation 7.842
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=64 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=69 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=56 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=107 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=118 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=133 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=135 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
Baseline
|
39.33 score on a scale
Standard Deviation 11.878
|
41.18 score on a scale
Standard Deviation 11.150
|
38.29 score on a scale
Standard Deviation 11.062
|
35.43 score on a scale
Standard Deviation 11.445
|
39.45 score on a scale
Standard Deviation 9.910
|
38.98 score on a scale
Standard Deviation 11.963
|
36.80 score on a scale
Standard Deviation 11.052
|
38.54 score on a scale
Standard Deviation 12.379
|
40.32 score on a scale
Standard Deviation 11.333
|
39.16 score on a scale
Standard Deviation 11.518
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
Change at Week 52
|
10.27 score on a scale
Standard Deviation 12.895
|
10.40 score on a scale
Standard Deviation 10.777
|
12.18 score on a scale
Standard Deviation 11.506
|
12.68 score on a scale
Standard Deviation 11.843
|
10.54 score on a scale
Standard Deviation 11.719
|
8.40 score on a scale
Standard Deviation 11.598
|
8.27 score on a scale
Standard Deviation 11.770
|
7.86 score on a scale
Standard Deviation 13.129
|
6.71 score on a scale
Standard Deviation 10.363
|
6.23 score on a scale
Standard Deviation 12.306
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=55 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=90 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=106 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=120 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=114 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
Baseline
|
39.79 score on a scale
Standard Deviation 8.801
|
41.33 score on a scale
Standard Deviation 8.517
|
40.07 score on a scale
Standard Deviation 7.625
|
37.03 score on a scale
Standard Deviation 7.675
|
37.92 score on a scale
Standard Deviation 8.353
|
39.59 score on a scale
Standard Deviation 7.809
|
37.53 score on a scale
Standard Deviation 8.286
|
37.47 score on a scale
Standard Deviation 8.147
|
40.73 score on a scale
Standard Deviation 8.552
|
39.25 score on a scale
Standard Deviation 7.667
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
Change at Week 76
|
9.69 score on a scale
Standard Deviation 9.714
|
8.97 score on a scale
Standard Deviation 8.891
|
10.54 score on a scale
Standard Deviation 6.416
|
10.48 score on a scale
Standard Deviation 7.797
|
11.98 score on a scale
Standard Deviation 9.496
|
10.28 score on a scale
Standard Deviation 7.651
|
7.77 score on a scale
Standard Deviation 8.397
|
8.82 score on a scale
Standard Deviation 8.501
|
9.73 score on a scale
Standard Deviation 8.461
|
7.31 score on a scale
Standard Deviation 8.436
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=55 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=90 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=106 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=120 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=114 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
Baseline
|
39.41 score on a scale
Standard Deviation 11.201
|
41.30 score on a scale
Standard Deviation 10.710
|
38.26 score on a scale
Standard Deviation 10.974
|
35.50 score on a scale
Standard Deviation 11.582
|
38.86 score on a scale
Standard Deviation 10.046
|
38.52 score on a scale
Standard Deviation 12.244
|
36.68 score on a scale
Standard Deviation 11.947
|
39.03 score on a scale
Standard Deviation 12.679
|
40.32 score on a scale
Standard Deviation 11.673
|
39.16 score on a scale
Standard Deviation 11.712
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
Change at Week 76
|
9.64 score on a scale
Standard Deviation 14.272
|
8.52 score on a scale
Standard Deviation 11.462
|
10.51 score on a scale
Standard Deviation 12.334
|
12.92 score on a scale
Standard Deviation 13.174
|
8.02 score on a scale
Standard Deviation 14.020
|
9.13 score on a scale
Standard Deviation 13.719
|
8.27 score on a scale
Standard Deviation 12.720
|
8.26 score on a scale
Standard Deviation 12.809
|
7.77 score on a scale
Standard Deviation 10.989
|
7.16 score on a scale
Standard Deviation 13.144
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=84 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=96 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=114 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=105 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
Baseline
|
41.26 score on a scale
Standard Deviation 8.825
|
41.03 score on a scale
Standard Deviation 8.260
|
40.29 score on a scale
Standard Deviation 7.480
|
36.97 score on a scale
Standard Deviation 7.677
|
38.11 score on a scale
Standard Deviation 8.169
|
39.59 score on a scale
Standard Deviation 7.989
|
37.26 score on a scale
Standard Deviation 7.974
|
37.90 score on a scale
Standard Deviation 8.297
|
41.13 score on a scale
Standard Deviation 8.579
|
39.28 score on a scale
Standard Deviation 7.458
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
Change at Week 100
|
10.28 score on a scale
Standard Deviation 8.418
|
9.41 score on a scale
Standard Deviation 7.934
|
9.42 score on a scale
Standard Deviation 7.556
|
11.18 score on a scale
Standard Deviation 8.322
|
12.97 score on a scale
Standard Deviation 9.396
|
10.78 score on a scale
Standard Deviation 8.926
|
8.47 score on a scale
Standard Deviation 8.096
|
9.45 score on a scale
Standard Deviation 8.747
|
9.70 score on a scale
Standard Deviation 8.869
|
7.40 score on a scale
Standard Deviation 8.473
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=84 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=96 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=114 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=105 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
Baseline
|
39.56 score on a scale
Standard Deviation 11.833
|
41.10 score on a scale
Standard Deviation 11.140
|
38.21 score on a scale
Standard Deviation 10.885
|
35.61 score on a scale
Standard Deviation 11.568
|
38.76 score on a scale
Standard Deviation 10.215
|
37.41 score on a scale
Standard Deviation 11.857
|
36.61 score on a scale
Standard Deviation 11.894
|
39.43 score on a scale
Standard Deviation 12.474
|
40.39 score on a scale
Standard Deviation 11.559
|
39.04 score on a scale
Standard Deviation 11.604
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
Change at Week 100
|
8.80 score on a scale
Standard Deviation 14.395
|
9.87 score on a scale
Standard Deviation 10.552
|
10.82 score on a scale
Standard Deviation 12.303
|
10.64 score on a scale
Standard Deviation 13.629
|
8.94 score on a scale
Standard Deviation 13.798
|
9.98 score on a scale
Standard Deviation 11.450
|
8.25 score on a scale
Standard Deviation 12.562
|
7.93 score on a scale
Standard Deviation 11.053
|
7.66 score on a scale
Standard Deviation 10.685
|
6.94 score on a scale
Standard Deviation 13.189
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=97 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=98 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
Baseline
|
41.75 score on a scale
Standard Deviation 7.947
|
41.08 score on a scale
Standard Deviation 8.219
|
39.88 score on a scale
Standard Deviation 7.332
|
37.00 score on a scale
Standard Deviation 7.854
|
38.58 score on a scale
Standard Deviation 8.078
|
39.31 score on a scale
Standard Deviation 8.279
|
37.09 score on a scale
Standard Deviation 8.044
|
38.36 score on a scale
Standard Deviation 8.240
|
41.10 score on a scale
Standard Deviation 8.747
|
39.01 score on a scale
Standard Deviation 7.363
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
Change at Week 124
|
10.12 score on a scale
Standard Deviation 9.685
|
7.91 score on a scale
Standard Deviation 9.483
|
10.15 score on a scale
Standard Deviation 8.551
|
11.79 score on a scale
Standard Deviation 8.053
|
12.87 score on a scale
Standard Deviation 8.803
|
11.01 score on a scale
Standard Deviation 8.319
|
8.36 score on a scale
Standard Deviation 7.495
|
7.77 score on a scale
Standard Deviation 9.228
|
10.56 score on a scale
Standard Deviation 8.804
|
9.27 score on a scale
Standard Deviation 8.274
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=97 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=98 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
Baseline
|
40.34 score on a scale
Standard Deviation 12.065
|
40.81 score on a scale
Standard Deviation 11.132
|
37.85 score on a scale
Standard Deviation 11.106
|
35.29 score on a scale
Standard Deviation 11.668
|
38.59 score on a scale
Standard Deviation 9.956
|
38.33 score on a scale
Standard Deviation 12.409
|
39.04 score on a scale
Standard Deviation 12.421
|
36.64 score on a scale
Standard Deviation 11.938
|
40.87 score on a scale
Standard Deviation 11.156
|
38.90 score on a scale
Standard Deviation 11.427
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
Change at Week 124
|
9.53 score on a scale
Standard Deviation 16.289
|
10.02 score on a scale
Standard Deviation 10.734
|
9.70 score on a scale
Standard Deviation 12.781
|
11.35 score on a scale
Standard Deviation 12.681
|
9.20 score on a scale
Standard Deviation 12.521
|
10.38 score on a scale
Standard Deviation 13.230
|
8.50 score on a scale
Standard Deviation 12.808
|
8.78 score on a scale
Standard Deviation 13.283
|
7.73 score on a scale
Standard Deviation 11.048
|
6.26 score on a scale
Standard Deviation 13.274
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=40 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=82 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=20 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=24 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
Baseline
|
41.75 score on a scale
Standard Deviation 7.947
|
41.33 score on a scale
Standard Deviation 8.438
|
39.86 score on a scale
Standard Deviation 7.312
|
36.68 score on a scale
Standard Deviation 8.055
|
39.22 score on a scale
Standard Deviation 7.511
|
39.21 score on a scale
Standard Deviation 8.303
|
36.94 score on a scale
Standard Deviation 8.087
|
37.99 score on a scale
Standard Deviation 8.430
|
43.32 score on a scale
Standard Deviation 10.405
|
38.77 score on a scale
Standard Deviation 7.024
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
Change at Week 148
|
9.08 score on a scale
Standard Deviation 9.090
|
9.35 score on a scale
Standard Deviation 8.228
|
10.34 score on a scale
Standard Deviation 6.524
|
12.15 score on a scale
Standard Deviation 9.941
|
12.54 score on a scale
Standard Deviation 9.695
|
11.26 score on a scale
Standard Deviation 7.231
|
9.37 score on a scale
Standard Deviation 8.223
|
8.94 score on a scale
Standard Deviation 8.442
|
9.81 score on a scale
Standard Deviation 8.727
|
10.39 score on a scale
Standard Deviation 6.824
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=40 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=82 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=20 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=24 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
Baseline
|
40.34 score on a scale
Standard Deviation 12.065
|
41.20 score on a scale
Standard Deviation 11.115
|
37.48 score on a scale
Standard Deviation 11.101
|
35.05 score on a scale
Standard Deviation 11.782
|
38.56 score on a scale
Standard Deviation 10.221
|
39.21 score on a scale
Standard Deviation 12.368
|
36.71 score on a scale
Standard Deviation 12.021
|
39.36 score on a scale
Standard Deviation 12.612
|
42.40 score on a scale
Standard Deviation 8.427
|
41.67 score on a scale
Standard Deviation 10.953
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
Change at Week 148
|
6.89 score on a scale
Standard Deviation 14.522
|
9.79 score on a scale
Standard Deviation 11.176
|
11.09 score on a scale
Standard Deviation 12.299
|
10.47 score on a scale
Standard Deviation 12.517
|
9.27 score on a scale
Standard Deviation 11.720
|
9.81 score on a scale
Standard Deviation 12.524
|
8.91 score on a scale
Standard Deviation 12.680
|
8.26 score on a scale
Standard Deviation 12.835
|
6.44 score on a scale
Standard Deviation 12.279
|
6.85 score on a scale
Standard Deviation 12.118
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=25 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=91 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=81 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
Baseline
|
42.23 score on a scale
Standard Deviation 8.073
|
41.52 score on a scale
Standard Deviation 8.401
|
40.23 score on a scale
Standard Deviation 6.713
|
37.29 score on a scale
Standard Deviation 8.057
|
38.82 score on a scale
Standard Deviation 8.231
|
39.16 score on a scale
Standard Deviation 8.177
|
36.92 score on a scale
Standard Deviation 8.023
|
37.85 score on a scale
Standard Deviation 8.538
|
41.12 score on a scale
Standard Deviation 9.029
|
39.30 score on a scale
Standard Deviation 7.264
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
Change at Week 172
|
10.08 score on a scale
Standard Deviation 8.996
|
9.20 score on a scale
Standard Deviation 8.324
|
9.68 score on a scale
Standard Deviation 6.804
|
11.83 score on a scale
Standard Deviation 8.042
|
13.21 score on a scale
Standard Deviation 9.194
|
10.88 score on a scale
Standard Deviation 7.837
|
9.61 score on a scale
Standard Deviation 8.461
|
9.07 score on a scale
Standard Deviation 7.519
|
10.47 score on a scale
Standard Deviation 8.921
|
8.55 score on a scale
Standard Deviation 8.546
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=25 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=91 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=81 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
Baseline
|
40.79 score on a scale
Standard Deviation 12.254
|
41.49 score on a scale
Standard Deviation 11.015
|
37.00 score on a scale
Standard Deviation 10.963
|
35.47 score on a scale
Standard Deviation 11.757
|
38.77 score on a scale
Standard Deviation 10.268
|
39.83 score on a scale
Standard Deviation 12.249
|
36.64 score on a scale
Standard Deviation 11.938
|
39.01 score on a scale
Standard Deviation 12.258
|
40.98 score on a scale
Standard Deviation 11.479
|
38.85 score on a scale
Standard Deviation 11.972
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
Change at Week 172
|
7.43 score on a scale
Standard Deviation 12.227
|
10.37 score on a scale
Standard Deviation 10.420
|
9.57 score on a scale
Standard Deviation 12.850
|
12.84 score on a scale
Standard Deviation 12.281
|
9.12 score on a scale
Standard Deviation 14.244
|
8.45 score on a scale
Standard Deviation 13.317
|
8.78 score on a scale
Standard Deviation 13.283
|
7.52 score on a scale
Standard Deviation 12.609
|
8.66 score on a scale
Standard Deviation 10.767
|
7.48 score on a scale
Standard Deviation 12.329
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=33 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=33 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=19 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
Baseline
|
40.72 score on a scale
Standard Deviation 7.823
|
40.83 score on a scale
Standard Deviation 8.135
|
40.52 score on a scale
Standard Deviation 7.242
|
35.64 score on a scale
Standard Deviation 7.862
|
36.65 score on a scale
Standard Deviation 9.250
|
39.33 score on a scale
Standard Deviation 8.136
|
39.53 score on a scale
Standard Deviation 7.830
|
38.40 score on a scale
Standard Deviation 9.680
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
Change at Week 196
|
11.82 score on a scale
Standard Deviation 9.370
|
9.98 score on a scale
Standard Deviation 7.569
|
9.31 score on a scale
Standard Deviation 5.771
|
12.35 score on a scale
Standard Deviation 8.867
|
14.10 score on a scale
Standard Deviation 10.616
|
11.75 score on a scale
Standard Deviation 8.261
|
6.94 score on a scale
Standard Deviation 8.667
|
9.83 score on a scale
Standard Deviation 8.111
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=33 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=33 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=19 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
Baseline
|
39.46 score on a scale
Standard Deviation 13.424
|
42.74 score on a scale
Standard Deviation 10.517
|
40.40 score on a scale
Standard Deviation 9.771
|
36.17 score on a scale
Standard Deviation 12.536
|
39.07 score on a scale
Standard Deviation 10.804
|
37.63 score on a scale
Standard Deviation 12.199
|
40.11 score on a scale
Standard Deviation 10.932
|
40.05 score on a scale
Standard Deviation 13.807
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
Change at Week 196
|
9.37 score on a scale
Standard Deviation 12.087
|
9.43 score on a scale
Standard Deviation 9.349
|
9.79 score on a scale
Standard Deviation 11.516
|
12.62 score on a scale
Standard Deviation 14.386
|
10.05 score on a scale
Standard Deviation 15.471
|
9.26 score on a scale
Standard Deviation 12.732
|
8.59 score on a scale
Standard Deviation 14.645
|
9.75 score on a scale
Standard Deviation 14.824
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=36 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
Baseline
|
39.99 score on a scale
Standard Deviation 7.219
|
40.71 score on a scale
Standard Deviation 7.605
|
39.33 score on a scale
Standard Deviation 6.820
|
37.54 score on a scale
Standard Deviation 8.054
|
38.32 score on a scale
Standard Deviation 8.047
|
40.28 score on a scale
Standard Deviation 8.878
|
37.95 score on a scale
Standard Deviation 8.232
|
37.77 score on a scale
Standard Deviation 8.654
|
39.17 score on a scale
Standard Deviation 13.987
|
38.79 score on a scale
Standard Deviation 7.735
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
Change at Week 248
|
11.22 score on a scale
Standard Deviation 10.562
|
9.95 score on a scale
Standard Deviation 8.355
|
11.43 score on a scale
Standard Deviation 8.047
|
11.70 score on a scale
Standard Deviation 6.541
|
13.88 score on a scale
Standard Deviation 8.511
|
9.98 score on a scale
Standard Deviation 9.027
|
9.32 score on a scale
Standard Deviation 9.261
|
10.50 score on a scale
Standard Deviation 8.803
|
15.98 score on a scale
Standard Deviation 7.868
|
9.88 score on a scale
Standard Deviation 6.977
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=36 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
Baseline
|
38.00 score on a scale
Standard Deviation 12.537
|
41.76 score on a scale
Standard Deviation 10.579
|
38.01 score on a scale
Standard Deviation 10.876
|
34.26 score on a scale
Standard Deviation 12.252
|
38.06 score on a scale
Standard Deviation 10.300
|
38.04 score on a scale
Standard Deviation 11.320
|
36.41 score on a scale
Standard Deviation 13.568
|
36.77 score on a scale
Standard Deviation 12.333
|
38.65 score on a scale
Standard Deviation 18.372
|
31.20 score on a scale
Standard Deviation 4.603
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
Change at Week 248
|
11.99 score on a scale
Standard Deviation 13.421
|
6.13 score on a scale
Standard Deviation 9.986
|
10.41 score on a scale
Standard Deviation 13.081
|
12.70 score on a scale
Standard Deviation 12.140
|
9.84 score on a scale
Standard Deviation 11.433
|
10.61 score on a scale
Standard Deviation 11.204
|
7.37 score on a scale
Standard Deviation 16.473
|
10.61 score on a scale
Standard Deviation 12.188
|
7.64 score on a scale
Standard Deviation 18.599
|
15.98 score on a scale
Standard Deviation 13.355
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=7 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=14 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=13 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=9 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=8 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
Baseline
|
36.89 score on a scale
Standard Deviation 5.913
|
38.84 score on a scale
Standard Deviation 7.720
|
39.22 score on a scale
Standard Deviation 5.469
|
36.56 score on a scale
Standard Deviation 8.514
|
34.80 score on a scale
Standard Deviation 8.431
|
39.97 score on a scale
Standard Deviation 6.626
|
41.04 score on a scale
Standard Deviation 12.016
|
34.80 score on a scale
Standard Deviation 10.515
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
Change at Week 300
|
12.03 score on a scale
Standard Deviation 10.338
|
10.58 score on a scale
Standard Deviation 8.335
|
11.15 score on a scale
Standard Deviation 6.497
|
15.47 score on a scale
Standard Deviation 9.920
|
14.42 score on a scale
Standard Deviation 6.749
|
10.69 score on a scale
Standard Deviation 6.448
|
9.10 score on a scale
Standard Deviation 9.330
|
6.41 score on a scale
Standard Deviation 9.023
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=7 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=14 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=13 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=9 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=8 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
Baseline
|
34.53 score on a scale
Standard Deviation 12.530
|
43.55 score on a scale
Standard Deviation 9.074
|
35.77 score on a scale
Standard Deviation 8.585
|
33.38 score on a scale
Standard Deviation 11.168
|
39.40 score on a scale
Standard Deviation 11.144
|
35.79 score on a scale
Standard Deviation 12.157
|
31.35 score on a scale
Standard Deviation 13.760
|
46.99 score on a scale
Standard Deviation 7.729
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
Change at Week 300
|
21.86 score on a scale
Standard Deviation 13.935
|
4.82 score on a scale
Standard Deviation 10.738
|
9.82 score on a scale
Standard Deviation 11.463
|
13.46 score on a scale
Standard Deviation 15.324
|
6.31 score on a scale
Standard Deviation 11.916
|
14.79 score on a scale
Standard Deviation 15.281
|
19.87 score on a scale
Standard Deviation 6.588
|
-3.67 score on a scale
Standard Deviation 20.577
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
Baseline
|
35.68 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
38.32 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
44.36 score on a scale
Standard Deviation 0.920
|
31.07 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
37.14 score on a scale
Standard Deviation 3.711
|
33.67 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
Change at Week 352
|
17.97 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
17.87 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
5.06 score on a scale
Standard Deviation 5.188
|
24.06 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
11.18 score on a scale
Standard Deviation 2.116
|
18.02 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
Baseline
|
42.19 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
35.34 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
32.72 score on a scale
Standard Deviation 7.252
|
22.18 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
39.80 score on a scale
Standard Deviation 14.563
|
42.98 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
Change at Week 352
|
17.40 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
19.87 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
14.14 score on a scale
Standard Deviation 10.114
|
25.04 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
8.65 score on a scale
Standard Deviation 7.463
|
13.08 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=67 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=52 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=126 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=136 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=151 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=162 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
Baseline
|
7.42 score on a scale
Standard Deviation 1.328
|
7.21 score on a scale
Standard Deviation 1.354
|
7.54 score on a scale
Standard Deviation 1.399
|
8.00 score on a scale
Standard Deviation 1.559
|
7.77 score on a scale
Standard Deviation 1.442
|
7.73 score on a scale
Standard Deviation 1.434
|
7.67 score on a scale
Standard Deviation 1.475
|
7.85 score on a scale
Standard Deviation 1.525
|
7.30 score on a scale
Standard Deviation 1.360
|
7.48 score on a scale
Standard Deviation 1.420
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
Change at Week 28
|
-1.29 score on a scale
Standard Deviation 1.873
|
-1.03 score on a scale
Standard Deviation 1.705
|
-1.44 score on a scale
Standard Deviation 1.568
|
-1.65 score on a scale
Standard Deviation 1.867
|
-1.82 score on a scale
Standard Deviation 1.675
|
-1.46 score on a scale
Standard Deviation 1.510
|
-0.75 score on a scale
Standard Deviation 1.648
|
-0.90 score on a scale
Standard Deviation 1.634
|
-0.96 score on a scale
Standard Deviation 1.380
|
-0.69 score on a scale
Standard Deviation 1.493
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=67 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=52 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=125 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=135 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=149 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=157 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
Baseline
|
58.4 score on a scale
Standard Deviation 20.96
|
62.1 score on a scale
Standard Deviation 16.54
|
53.5 score on a scale
Standard Deviation 17.30
|
51.5 score on a scale
Standard Deviation 17.57
|
52.2 score on a scale
Standard Deviation 18.72
|
52.3 score on a scale
Standard Deviation 18.39
|
53.2 score on a scale
Standard Deviation 18.02
|
51.3 score on a scale
Standard Deviation 19.09
|
56.4 score on a scale
Standard Deviation 19.64
|
55.6 score on a scale
Standard Deviation 16.72
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
Change at Week 28
|
22.7 score on a scale
Standard Deviation 24.11
|
20.0 score on a scale
Standard Deviation 18.75
|
25.1 score on a scale
Standard Deviation 22.09
|
23.8 score on a scale
Standard Deviation 23.79
|
27.6 score on a scale
Standard Deviation 22.58
|
23.7 score on a scale
Standard Deviation 22.51
|
16.8 score on a scale
Standard Deviation 22.55
|
19.9 score on a scale
Standard Deviation 22.44
|
17.1 score on a scale
Standard Deviation 21.75
|
13.4 score on a scale
Standard Deviation 19.48
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=65 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=56 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=107 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=118 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=133 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=135 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
Baseline
|
7.50 score on a scale
Standard Deviation 1.368
|
7.17 score on a scale
Standard Deviation 1.318
|
7.54 score on a scale
Standard Deviation 1.390
|
8.08 score on a scale
Standard Deviation 1.499
|
7.75 score on a scale
Standard Deviation 1.468
|
7.65 score on a scale
Standard Deviation 1.358
|
7.62 score on a scale
Standard Deviation 1.398
|
7.74 score on a scale
Standard Deviation 1.538
|
7.33 score on a scale
Standard Deviation 1.386
|
7.49 score on a scale
Standard Deviation 1.429
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
Change at Week 52
|
-1.59 score on a scale
Standard Deviation 1.775
|
-1.00 score on a scale
Standard Deviation 1.571
|
-1.43 score on a scale
Standard Deviation 1.556
|
-1.60 score on a scale
Standard Deviation 1.673
|
-1.77 score on a scale
Standard Deviation 1.640
|
-1.46 score on a scale
Standard Deviation 1.457
|
-0.87 score on a scale
Standard Deviation 1.666
|
-1.15 score on a scale
Standard Deviation 1.703
|
-0.95 score on a scale
Standard Deviation 1.551
|
-0.85 score on a scale
Standard Deviation 1.637
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=65 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=56 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=105 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=118 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=129 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=133 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
Baseline
|
57.5 score on a scale
Standard Deviation 21.39
|
61.9 score on a scale
Standard Deviation 16.18
|
52.3 score on a scale
Standard Deviation 18.09
|
50.8 score on a scale
Standard Deviation 17.82
|
52.6 score on a scale
Standard Deviation 19.43
|
52.7 score on a scale
Standard Deviation 18.38
|
53.3 score on a scale
Standard Deviation 17.21
|
52.2 score on a scale
Standard Deviation 18.94
|
55.9 score on a scale
Standard Deviation 20.51
|
56.3 score on a scale
Standard Deviation 16.21
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
Change at Week 52
|
22.9 score on a scale
Standard Deviation 27.46
|
18.5 score on a scale
Standard Deviation 20.31
|
27.0 score on a scale
Standard Deviation 21.87
|
27.9 score on a scale
Standard Deviation 20.70
|
30.8 score on a scale
Standard Deviation 21.59
|
25.0 score on a scale
Standard Deviation 18.85
|
19.9 score on a scale
Standard Deviation 22.83
|
23.5 score on a scale
Standard Deviation 23.03
|
20.8 score on a scale
Standard Deviation 21.93
|
17.6 score on a scale
Standard Deviation 22.69
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=89 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=106 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=120 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=113 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76
Baseline
|
7.48 score on a scale
Standard Deviation 1.379
|
7.18 score on a scale
Standard Deviation 1.337
|
7.56 score on a scale
Standard Deviation 1.267
|
8.11 score on a scale
Standard Deviation 1.434
|
7.72 score on a scale
Standard Deviation 1.420
|
7.64 score on a scale
Standard Deviation 1.385
|
7.69 score on a scale
Standard Deviation 1.489
|
7.74 score on a scale
Standard Deviation 1.545
|
7.28 score on a scale
Standard Deviation 1.348
|
7.52 score on a scale
Standard Deviation 1.464
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76
Change at Week 76
|
-1.38 score on a scale
Standard Deviation 1.498
|
-1.05 score on a scale
Standard Deviation 1.583
|
-1.33 score on a scale
Standard Deviation 1.513
|
-1.67 score on a scale
Standard Deviation 1.430
|
-1.50 score on a scale
Standard Deviation 1.724
|
-1.52 score on a scale
Standard Deviation 1.466
|
-1.11 score on a scale
Standard Deviation 1.518
|
-1.14 score on a scale
Standard Deviation 1.496
|
-1.26 score on a scale
Standard Deviation 1.481
|
-1.05 score on a scale
Standard Deviation 1.546
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=29 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=63 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=44 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=57 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=88 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=106 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=119 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=113 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76
Baseline
|
58.8 score on a scale
Standard Deviation 21.93
|
62.3 score on a scale
Standard Deviation 17.01
|
52.0 score on a scale
Standard Deviation 18.47
|
50.7 score on a scale
Standard Deviation 16.81
|
52.0 score on a scale
Standard Deviation 19.38
|
52.4 score on a scale
Standard Deviation 18.88
|
52.5 score on a scale
Standard Deviation 17.18
|
51.4 score on a scale
Standard Deviation 18.99
|
56.1 score on a scale
Standard Deviation 20.36
|
55.8 score on a scale
Standard Deviation 16.19
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76
Change at Week 76
|
20.9 score on a scale
Standard Deviation 25.66
|
18.7 score on a scale
Standard Deviation 20.65
|
25.1 score on a scale
Standard Deviation 19.62
|
27.3 score on a scale
Standard Deviation 18.87
|
30.3 score on a scale
Standard Deviation 23.68
|
27.0 score on a scale
Standard Deviation 21.49
|
22.2 score on a scale
Standard Deviation 20.82
|
23.3 score on a scale
Standard Deviation 21.40
|
19.2 score on a scale
Standard Deviation 25.10
|
17.8 score on a scale
Standard Deviation 22.04
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=55 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=84 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=96 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=114 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=105 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100
Baseline
|
7.48 score on a scale
Standard Deviation 1.451
|
7.22 score on a scale
Standard Deviation 1.325
|
7.55 score on a scale
Standard Deviation 1.391
|
8.04 score on a scale
Standard Deviation 1.507
|
7.69 score on a scale
Standard Deviation 1.446
|
7.67 score on a scale
Standard Deviation 1.375
|
7.71 score on a scale
Standard Deviation 1.428
|
7.71 score on a scale
Standard Deviation 1.507
|
7.28 score on a scale
Standard Deviation 1.360
|
7.53 score on a scale
Standard Deviation 1.401
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100
Change at Week 100
|
-1.48 score on a scale
Standard Deviation 1.602
|
-1.26 score on a scale
Standard Deviation 1.528
|
-1.43 score on a scale
Standard Deviation 1.452
|
-1.64 score on a scale
Standard Deviation 1.773
|
-1.73 score on a scale
Standard Deviation 1.741
|
-1.62 score on a scale
Standard Deviation 1.394
|
-1.04 score on a scale
Standard Deviation 1.609
|
-1.16 score on a scale
Standard Deviation 1.538
|
-1.37 score on a scale
Standard Deviation 1.477
|
-0.98 score on a scale
Standard Deviation 1.473
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=44 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=82 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=95 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=112 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=103 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100
Baseline
|
59.2 score on a scale
Standard Deviation 22.81
|
61.3 score on a scale
Standard Deviation 16.80
|
52.9 score on a scale
Standard Deviation 16.94
|
50.7 score on a scale
Standard Deviation 16.81
|
53.8 score on a scale
Standard Deviation 18.76
|
51.9 score on a scale
Standard Deviation 19.02
|
51.9 score on a scale
Standard Deviation 16.53
|
52.2 score on a scale
Standard Deviation 19.18
|
56.5 score on a scale
Standard Deviation 20.68
|
55.3 score on a scale
Standard Deviation 16.49
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100
Change at Week 100
|
20.4 score on a scale
Standard Deviation 27.47
|
20.7 score on a scale
Standard Deviation 17.45
|
26.4 score on a scale
Standard Deviation 21.82
|
26.9 score on a scale
Standard Deviation 22.39
|
29.4 score on a scale
Standard Deviation 23.09
|
26.9 score on a scale
Standard Deviation 21.76
|
22.3 score on a scale
Standard Deviation 20.11
|
23.1 score on a scale
Standard Deviation 21.82
|
19.4 score on a scale
Standard Deviation 26.78
|
16.6 score on a scale
Standard Deviation 21.92
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=97 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=98 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124
Baseline
|
7.33 score on a scale
Standard Deviation 1.271
|
7.24 score on a scale
Standard Deviation 1.329
|
7.61 score on a scale
Standard Deviation 1.406
|
8.14 score on a scale
Standard Deviation 1.457
|
7.62 score on a scale
Standard Deviation 1.423
|
7.69 score on a scale
Standard Deviation 1.446
|
7.73 score on a scale
Standard Deviation 1.441
|
7.65 score on a scale
Standard Deviation 1.510
|
7.28 score on a scale
Standard Deviation 1.223
|
7.54 score on a scale
Standard Deviation 1.401
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124
Change at Week 124
|
-1.52 score on a scale
Standard Deviation 1.805
|
-1.07 score on a scale
Standard Deviation 1.566
|
-1.52 score on a scale
Standard Deviation 1.539
|
-1.70 score on a scale
Standard Deviation 1.655
|
-1.60 score on a scale
Standard Deviation 1.690
|
-1.69 score on a scale
Standard Deviation 1.560
|
-0.85 score on a scale
Standard Deviation 1.662
|
-1.05 score on a scale
Standard Deviation 1.637
|
-1.34 score on a scale
Standard Deviation 1.560
|
-1.07 score on a scale
Standard Deviation 1.639
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=58 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=42 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=47 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=79 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=82 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=96 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=95 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124
Baseline
|
61.2 score on a scale
Standard Deviation 21.60
|
61.6 score on a scale
Standard Deviation 16.98
|
52.0 score on a scale
Standard Deviation 16.58
|
50.0 score on a scale
Standard Deviation 16.87
|
54.8 score on a scale
Standard Deviation 17.87
|
52.4 score on a scale
Standard Deviation 19.58
|
51.8 score on a scale
Standard Deviation 16.77
|
52.8 score on a scale
Standard Deviation 19.62
|
56.1 score on a scale
Standard Deviation 20.59
|
55.6 score on a scale
Standard Deviation 15.81
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124
Change at Week 124
|
24.0 score on a scale
Standard Deviation 25.45
|
19.7 score on a scale
Standard Deviation 18.12
|
23.8 score on a scale
Standard Deviation 21.39
|
29.4 score on a scale
Standard Deviation 21.15
|
28.1 score on a scale
Standard Deviation 20.71
|
24.5 score on a scale
Standard Deviation 28.36
|
21.1 score on a scale
Standard Deviation 21.77
|
23.8 score on a scale
Standard Deviation 21.41
|
22.2 score on a scale
Standard Deviation 26.13
|
18.1 score on a scale
Standard Deviation 24.00
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=76 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=94 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=93 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148
Baseline
|
7.33 score on a scale
Standard Deviation 1.271
|
7.20 score on a scale
Standard Deviation 1.337
|
7.64 score on a scale
Standard Deviation 1.415
|
8.17 score on a scale
Standard Deviation 1.447
|
7.60 score on a scale
Standard Deviation 1.450
|
7.65 score on a scale
Standard Deviation 1.370
|
7.75 score on a scale
Standard Deviation 1.434
|
7.72 score on a scale
Standard Deviation 1.541
|
7.31 score on a scale
Standard Deviation 1.376
|
7.52 score on a scale
Standard Deviation 1.396
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148
Change at Week 148
|
-1.30 score on a scale
Standard Deviation 1.589
|
-1.26 score on a scale
Standard Deviation 1.544
|
-1.62 score on a scale
Standard Deviation 1.417
|
-1.66 score on a scale
Standard Deviation 1.559
|
-1.74 score on a scale
Standard Deviation 1.774
|
-1.67 score on a scale
Standard Deviation 1.175
|
-1.11 score on a scale
Standard Deviation 1.740
|
-1.36 score on a scale
Standard Deviation 1.679
|
-1.47 score on a scale
Standard Deviation 1.591
|
-1.24 score on a scale
Standard Deviation 1.644
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=54 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=40 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=83 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=92 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=91 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148
Baseline
|
61.2 score on a scale
Standard Deviation 21.60
|
61.5 score on a scale
Standard Deviation 17.24
|
51.4 score on a scale
Standard Deviation 16.62
|
49.4 score on a scale
Standard Deviation 17.04
|
54.3 score on a scale
Standard Deviation 18.04
|
52.1 score on a scale
Standard Deviation 19.63
|
51.5 score on a scale
Standard Deviation 16.66
|
52.0 score on a scale
Standard Deviation 19.73
|
56.2 score on a scale
Standard Deviation 20.93
|
55.6 score on a scale
Standard Deviation 16.31
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148
Change at Week 148
|
23.4 score on a scale
Standard Deviation 27.31
|
21.9 score on a scale
Standard Deviation 18.53
|
28.7 score on a scale
Standard Deviation 19.43
|
28.2 score on a scale
Standard Deviation 20.56
|
28.2 score on a scale
Standard Deviation 21.30
|
24.7 score on a scale
Standard Deviation 22.11
|
24.9 score on a scale
Standard Deviation 25.63
|
24.6 score on a scale
Standard Deviation 22.24
|
23.9 score on a scale
Standard Deviation 23.40
|
21.1 score on a scale
Standard Deviation 22.50
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=25 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=49 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=91 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=81 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172
Baseline
|
7.28 score on a scale
Standard Deviation 1.308
|
7.17 score on a scale
Standard Deviation 1.326
|
7.67 score on a scale
Standard Deviation 1.449
|
8.03 score on a scale
Standard Deviation 1.385
|
7.65 score on a scale
Standard Deviation 1.446
|
7.70 score on a scale
Standard Deviation 1.337
|
7.71 score on a scale
Standard Deviation 1.436
|
7.81 score on a scale
Standard Deviation 1.548
|
7.33 score on a scale
Standard Deviation 1.407
|
7.62 score on a scale
Standard Deviation 1.428
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172
Change at Week 172
|
-1.24 score on a scale
Standard Deviation 1.535
|
-1.19 score on a scale
Standard Deviation 1.665
|
-1.45 score on a scale
Standard Deviation 1.569
|
-1.76 score on a scale
Standard Deviation 1.747
|
-1.74 score on a scale
Standard Deviation 1.747
|
-1.72 score on a scale
Standard Deviation 1.098
|
-1.07 score on a scale
Standard Deviation 1.722
|
-1.27 score on a scale
Standard Deviation 1.695
|
-1.52 score on a scale
Standard Deviation 1.546
|
-1.23 score on a scale
Standard Deviation 1.653
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=25 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=53 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=48 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=43 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=42 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=70 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=75 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=90 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=80 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172
Baseline
|
61.6 score on a scale
Standard Deviation 22.40
|
62.1 score on a scale
Standard Deviation 16.84
|
51.3 score on a scale
Standard Deviation 16.87
|
49.7 score on a scale
Standard Deviation 17.87
|
54.2 score on a scale
Standard Deviation 17.79
|
52.4 score on a scale
Standard Deviation 20.42
|
51.3 score on a scale
Standard Deviation 16.58
|
50.9 score on a scale
Standard Deviation 19.40
|
55.9 score on a scale
Standard Deviation 20.95
|
55.4 score on a scale
Standard Deviation 15.90
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172
Change at Week 172
|
19.8 score on a scale
Standard Deviation 27.91
|
20.3 score on a scale
Standard Deviation 21.59
|
25.9 score on a scale
Standard Deviation 21.53
|
29.2 score on a scale
Standard Deviation 22.92
|
29.4 score on a scale
Standard Deviation 21.40
|
25.9 score on a scale
Standard Deviation 25.70
|
26.0 score on a scale
Standard Deviation 20.30
|
23.9 score on a scale
Standard Deviation 23.72
|
25.2 score on a scale
Standard Deviation 22.04
|
22.2 score on a scale
Standard Deviation 21.21
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=50 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=66 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=51 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196
Baseline
|
7.33 score on a scale
Standard Deviation 1.271
|
7.14 score on a scale
Standard Deviation 1.325
|
7.54 score on a scale
Standard Deviation 1.312
|
8.11 score on a scale
Standard Deviation 1.487
|
7.68 score on a scale
Standard Deviation 1.474
|
7.66 score on a scale
Standard Deviation 1.389
|
7.71 score on a scale
Standard Deviation 1.476
|
7.82 score on a scale
Standard Deviation 1.579
|
7.34 score on a scale
Standard Deviation 1.292
|
7.61 score on a scale
Standard Deviation 1.297
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196
Change at Week 196
|
-1.30 score on a scale
Standard Deviation 1.436
|
-1.06 score on a scale
Standard Deviation 1.490
|
-1.52 score on a scale
Standard Deviation 1.426
|
-1.89 score on a scale
Standard Deviation 1.449
|
-1.85 score on a scale
Standard Deviation 1.783
|
-1.90 score on a scale
Standard Deviation 1.375
|
-1.12 score on a scale
Standard Deviation 1.687
|
-1.42 score on a scale
Standard Deviation 1.555
|
-1.44 score on a scale
Standard Deviation 1.656
|
-1.37 score on a scale
Standard Deviation 1.697
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=27 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=50 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=46 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=41 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=66 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=71 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=62 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=51 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196
Baseline
|
61.2 score on a scale
Standard Deviation 21.60
|
61.3 score on a scale
Standard Deviation 16.63
|
52.5 score on a scale
Standard Deviation 17.01
|
49.0 score on a scale
Standard Deviation 18.41
|
54.2 score on a scale
Standard Deviation 17.71
|
52.8 score on a scale
Standard Deviation 20.56
|
51.5 score on a scale
Standard Deviation 16.72
|
51.5 score on a scale
Standard Deviation 19.58
|
56.7 score on a scale
Standard Deviation 20.21
|
56.5 score on a scale
Standard Deviation 14.35
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196
Change at Week 196
|
22.9 score on a scale
Standard Deviation 28.01
|
21.6 score on a scale
Standard Deviation 17.20
|
26.4 score on a scale
Standard Deviation 20.17
|
31.9 score on a scale
Standard Deviation 23.39
|
29.1 score on a scale
Standard Deviation 22.45
|
29.2 score on a scale
Standard Deviation 22.32
|
24.6 score on a scale
Standard Deviation 21.32
|
23.3 score on a scale
Standard Deviation 26.17
|
22.1 score on a scale
Standard Deviation 22.91
|
23.2 score on a scale
Standard Deviation 18.14
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=36 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248
Baseline
|
7.48 score on a scale
Standard Deviation 1.365
|
7.21 score on a scale
Standard Deviation 1.119
|
7.69 score on a scale
Standard Deviation 1.215
|
8.09 score on a scale
Standard Deviation 1.510
|
7.66 score on a scale
Standard Deviation 1.450
|
7.84 score on a scale
Standard Deviation 1.463
|
7.63 score on a scale
Standard Deviation 1.532
|
7.89 score on a scale
Standard Deviation 1.541
|
7.33 score on a scale
Standard Deviation 1.155
|
7.75 score on a scale
Standard Deviation 1.500
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248
Change at Week 248
|
-1.67 score on a scale
Standard Deviation 1.653
|
-1.03 score on a scale
Standard Deviation 1.619
|
-1.58 score on a scale
Standard Deviation 1.339
|
-2.03 score on a scale
Standard Deviation 1.425
|
-1.81 score on a scale
Standard Deviation 1.554
|
-1.97 score on a scale
Standard Deviation 1.538
|
-1.05 score on a scale
Standard Deviation 2.039
|
-1.57 score on a scale
Standard Deviation 1.521
|
-2.00 score on a scale
Standard Deviation 1.000
|
-2.00 score on a scale
Standard Deviation 1.414
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=21 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=37 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=36 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=32 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=31 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=38 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=45 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248
Change at Week 248
|
27.5 score on a scale
Standard Deviation 25.77
|
17.7 score on a scale
Standard Deviation 18.62
|
28.0 score on a scale
Standard Deviation 22.14
|
34.9 score on a scale
Standard Deviation 18.79
|
32.1 score on a scale
Standard Deviation 19.98
|
29.9 score on a scale
Standard Deviation 24.37
|
24.7 score on a scale
Standard Deviation 25.34
|
28.9 score on a scale
Standard Deviation 27.65
|
28.7 score on a scale
Standard Deviation 32.72
|
34.3 score on a scale
Standard Deviation 11.44
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248
Baseline
|
57.2 score on a scale
Standard Deviation 21.28
|
61.6 score on a scale
Standard Deviation 16.17
|
52.1 score on a scale
Standard Deviation 16.63
|
47.2 score on a scale
Standard Deviation 18.17
|
52.3 score on a scale
Standard Deviation 16.40
|
53.2 score on a scale
Standard Deviation 19.72
|
50.8 score on a scale
Standard Deviation 17.39
|
49.0 score on a scale
Standard Deviation 19.37
|
61.3 score on a scale
Standard Deviation 28.11
|
47.5 score on a scale
Standard Deviation 7.33
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=7 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=14 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=13 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=9 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=8 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300
Baseline
|
8.14 score on a scale
Standard Deviation 1.069
|
7.50 score on a scale
Standard Deviation 0.941
|
8.08 score on a scale
Standard Deviation 1.115
|
8.33 score on a scale
Standard Deviation 1.803
|
7.88 score on a scale
Standard Deviation 1.356
|
7.94 score on a scale
Standard Deviation 1.063
|
7.75 score on a scale
Standard Deviation 2.062
|
7.00 score on a scale
Standard Deviation 0.000
|
—
|
—
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300
Change at Week 300
|
-2.29 score on a scale
Standard Deviation 1.799
|
-1.43 score on a scale
Standard Deviation 2.065
|
-1.77 score on a scale
Standard Deviation 1.363
|
-2.11 score on a scale
Standard Deviation 1.965
|
-2.00 score on a scale
Standard Deviation 2.138
|
-2.25 score on a scale
Standard Deviation 1.438
|
-1.50 score on a scale
Standard Deviation 1.291
|
0.50 score on a scale
Standard Deviation 2.121
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=7 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=14 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=13 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=9 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=8 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=16 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
n=4 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300
Baseline
|
58.1 score on a scale
Standard Deviation 20.27
|
64.9 score on a scale
Standard Deviation 11.82
|
55.7 score on a scale
Standard Deviation 10.10
|
50.4 score on a scale
Standard Deviation 22.34
|
53.1 score on a scale
Standard Deviation 15.80
|
42.9 score on a scale
Standard Deviation 19.54
|
43.5 score on a scale
Standard Deviation 19.12
|
52.0 score on a scale
Standard Deviation 24.04
|
—
|
—
|
|
Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300
Change at Week 300
|
23.6 score on a scale
Standard Deviation 29.14
|
20.4 score on a scale
Standard Deviation 17.92
|
28.4 score on a scale
Standard Deviation 14.78
|
33.2 score on a scale
Standard Deviation 25.83
|
31.3 score on a scale
Standard Deviation 17.47
|
43.6 score on a scale
Standard Deviation 23.17
|
40.3 score on a scale
Standard Deviation 9.50
|
13.0 score on a scale
Standard Deviation 11.31
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352
Baseline
|
8.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
8.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
8.33 score on a scale
Standard Deviation 0.577
|
12.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
8.00 score on a scale
Standard Deviation 1.414
|
9.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352
Change at Week 352
|
-2.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
-3.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
-1.33 score on a scale
Standard Deviation 1.528
|
-6.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
-1.00 score on a scale
Standard Deviation 0.000
|
-4.00 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Vedolizumab 300 mg (C13006 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase.
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.
|
Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
n=3 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.
|
Vedolizumab 300 mg (C13007 Placebo)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
n=2 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.
|
Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
n=1 Participants
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.
|
Vedolizumab 300 mg (C13011 Placebo)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13011 Vedolizumab)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
|
Vedolizumab 300 mg (C13008 De Novo Participants - UC)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.
|
Vedolizumab 300 mg (C13008 De Novo Participants - CD)
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn's disease not treated in a previous study.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352
Change at Week 352
|
46.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
40.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
24.3 score on a scale
Standard Deviation 20.11
|
64.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
24.0 score on a scale
Standard Deviation 8.49
|
59.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
|
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352
Baseline
|
52.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
50.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
48.0 score on a scale
Standard Deviation 8.19
|
15.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
50.0 score on a scale
Standard Deviation 14.14
|
31.0 score on a scale
Standard Deviation NA
SD was not calculated for 1 participant.
|
—
|
—
|
—
|
—
|
Adverse Events
Vedolizumab 300 mg
Serious events: 825 serious events
Other events: 1820 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Vedolizumab 300 mg
n=2243 participants at risk
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13006, C13007 and C13011.
|
|---|---|
|
Gastrointestinal disorders
Crohn's disease
|
10.0%
225/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Epiploic appendagitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pouchitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
5.3%
120/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.2%
50/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
29/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.62%
14/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal stenosis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.76%
17/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.36%
8/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.67%
15/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterocutaneous fistula
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
10/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.31%
7/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
9/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colon dysplasia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectal stenosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Food poisoning
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Peritonitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Megacolon
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Periproctitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Anal abscess
|
1.5%
33/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.85%
19/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis
|
0.76%
17/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.58%
13/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diverticulitis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abdominal wall abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Enterocolitis infectious
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Rectal abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia
|
0.94%
21/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lobar pneumonia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Lung infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.49%
11/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridial infection
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Clostridium colitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cellulitis
|
0.31%
7/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Asymptomatic bacteriuria
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vaginal cellulitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sepsis
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Septic shock
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urosepsis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Meningitis viral
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Viral infection
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Laryngitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Peritonsillar abscess
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tonsillitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pelvic abscess
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Blister infected
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pilonidal cyst
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Klebsiella infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Klebsiella sepsis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Abscess jaw
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Campylobacter intestinal infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Meningitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tooth abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infectious mononucleosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vulval abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
West Nile viral infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Giardiasis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Cholangitis suppurative
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes simplex
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Psoas abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Tinea pedis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Infusion site infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the appendix
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula discharge
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.31%
7/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
7/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.31%
7/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pain
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Hernia obstructive
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Device dislocation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pseudopolyp
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
No therapeutic response
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.45%
10/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Sciatica
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Aphasia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Syncope
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Grand mal convulsion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Migraine
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Multiple sclerosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Optic neuritis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Convulsion
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Spinal cord compression
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
11/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal colic
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urethral prolapse
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.62%
14/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.27%
6/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.22%
5/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Ovarian adhesion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Ovarian mass
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Cystocele
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Myopericarditis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Tachycardia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Depression
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Stress
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Homicidal ideation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Affective disorder
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
3/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Axillary vein thrombosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypertension
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Thrombosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Varicose vein
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight decreased
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood glucose increased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
C-reactive protein increased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin decreased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Scar
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Uveitis
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vitreous floaters
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Retinal detachment
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vision blurred
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Congenital, familial and genetic disorders
Vitello-intestinal duct remnant
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.18%
4/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Malaise
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
General physical health deterioration
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Renal failure acute
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Intracranial hypotension
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Liver function test abnormal
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Serum sickness
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Rectourethral fistula
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vulval cellulitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Enterocolitis viral
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Vestibular neuronitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Acute sinusitis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Postoperative abscess
|
0.09%
2/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Incision site infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Peridiverticular abscess
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Ear infection
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Mastoiditis
|
0.04%
1/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Vedolizumab 300 mg
n=2243 participants at risk
Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13006, C13007 and C13011.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
26.5%
594/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.9%
379/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
10.5%
235/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
9.6%
216/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
9.6%
216/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
9.3%
208/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
7.8%
175/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.5%
393/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
14.8%
333/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
14.8%
333/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
284/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
11.2%
251/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.1%
227/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
139/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.5%
482/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.7%
239/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.6%
125/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
121/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
20.2%
452/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
7.2%
162/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Pyrexia
|
12.3%
277/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
10.2%
229/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
6.6%
148/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.2%
251/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.5%
168/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
8.1%
181/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.8%
153/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.4%
122/2243 • From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
- Publication restrictions are in place
Restriction type: OTHER