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Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03138655
Recruitment Status : Completed
First Posted : May 3, 2017
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Collaborators:
Takeda Development Center Americas, Inc.
Takeda Development Centre Europe Ltd.
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Ulcerative Colitis
Crohn's Disease
Intervention Drug: Vedolizumab
Enrollment 89
Recruitment Details Participants took part in the study at 72 investigative sites in United States, Belgium, Canada, France, Germany, Hungary, Israel, Netherlands, Poland, Ukraine, United Kingdom and European Union from 8 November 2017 to 26 March 2020.
Pre-assignment Details Pediatric participants who weighed >10 kg with a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) were enrolled in 1:1 ratio to receive vedolizumab low or high dose groups per weight (<30 kg and >=30 kg).
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Period Title: Overall Study
Started 10 9 11 10 13 12 12 12
Completed 7 7 9 7 11 7 9 10
Not Completed 3 2 2 3 2 5 3 2
Reason Not Completed
Adverse Event             2             1             2             1             1             4             2             2
Withdrawal by Subject             0             1             0             0             0             0             1             0
Reason not Specified             1             0             0             2             1             1             0             0
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg Total
Hide Arm/Group Description Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Total of all reporting groups
Overall Number of Baseline Participants 10 9 11 10 13 12 12 12 89
Hide Baseline Analysis Population Description
Randomized Set included all participants who are randomized into the study regardless whether they received any dose of study drug or not.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
7.0
(3 to 12)
8.0
(2 to 12)
7.4
(2 to 12)
8.1
(3 to 12)
12.4
(8 to 17)
13.9
(9 to 17)
13.4
(10 to 17)
14.3
(11 to 17)
10.56
(2 to 17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
Female
4
  40.0%
4
  44.4%
4
  36.4%
5
  50.0%
5
  38.5%
6
  50.0%
8
  66.7%
3
  25.0%
39
  43.8%
Male
6
  60.0%
5
  55.6%
7
  63.6%
5
  50.0%
8
  61.5%
6
  50.0%
4
  33.3%
9
  75.0%
50
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
Hispanic or Latino
0
   0.0%
2
  22.2%
2
  18.2%
2
  20.0%
1
   7.7%
1
   8.3%
1
   8.3%
0
   0.0%
9
  10.1%
Not Hispanic or Latino
10
 100.0%
7
  77.8%
7
  63.6%
8
  80.0%
12
  92.3%
11
  91.7%
11
  91.7%
12
 100.0%
78
  87.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
2
  18.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
1
   8.3%
2
   2.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  10.0%
2
  22.2%
1
   9.1%
0
   0.0%
2
  15.4%
0
   0.0%
2
  16.7%
0
   0.0%
8
   9.0%
White
7
  70.0%
7
  77.8%
7
  63.6%
9
  90.0%
11
  84.6%
10
  83.3%
9
  75.0%
11
  91.7%
71
  79.8%
More than one race
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
0
   0.0%
3
   3.4%
Unknown or Not Reported
2
  20.0%
0
   0.0%
2
  18.2%
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5
   5.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
Belgium
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
2
  16.7%
1
   8.3%
5
   5.6%
France
0
   0.0%
0
   0.0%
1
   9.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
Hungary
1
  10.0%
0
   0.0%
1
   9.1%
1
  10.0%
3
  23.1%
4
  33.3%
4
  33.3%
3
  25.0%
17
  19.1%
Poland
2
  20.0%
1
  11.1%
4
  36.4%
2
  20.0%
1
   7.7%
0
   0.0%
2
  16.7%
3
  25.0%
15
  16.9%
United Kingdom
0
   0.0%
0
   0.0%
1
   9.1%
1
  10.0%
1
   7.7%
0
   0.0%
1
   8.3%
2
  16.7%
6
   6.7%
Ukraine
1
  10.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.2%
Israel
3
  30.0%
2
  22.2%
0
   0.0%
2
  20.0%
3
  23.1%
2
  16.7%
0
   0.0%
1
   8.3%
13
  14.6%
Canada
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
1
   1.1%
United States
2
  20.0%
5
  55.6%
4
  36.4%
4
  40.0%
5
  38.5%
5
  41.7%
2
  16.7%
2
  16.7%
29
  32.6%
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
119.59
(82.7 to 146.0)
122.39
(84.9 to 143.0)
120.58
(83.5 to 146.0)
124.67
(96.5 to 137.6)
153.11
(128.0 to 176.1)
160.03
(138.3 to 185.4)
157.85
(134.3 to 182.5)
157.98
(141.9 to 181.5)
139.53
(82.7 to 185.4)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
22.38
(12.8 to 29.6)
23.23
(10.2 to 29.8)
22.06
(12.0 to 29.9)
23.37
(14.3 to 30.0)
46.22
(30.3 to 75.9)
53.98
(32.0 to 78.9)
51.53
(31.4 to 79.0)
45.89
(33.9 to 68.0)
36.08
(10.2 to 79.0)
Body Mass Index (BMI)   [1] 
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 10 participants 9 participants 11 participants 10 participants 13 participants 12 participants 12 participants 12 participants 89 participants
15.63
(13.4 to 18.7)
15.29
(12.4 to 20.0)
15.04
(13.5 to 17.2)
14.93
(12.4 to 16.9)
19.51
(16.4 to 26.5)
20.76
(16.7 to 27.1)
20.50
(14.4 to 24.5)
18.26
(15.8 to 25.9)
17.49
(12.4 to 27.1)
[1]
Measure Description: BMI = weight (kg) / height^2 (m^2)
1.Primary Outcome
Title AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14
Hide Description [Not Specified]
Time Frame From Day 43 (Week 6) post-dose up to pre-dose Day 99 (Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description:
Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Overall Number of Participants Analyzed 8 7 7 8 11 10 9 10
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
1933.5076  (1184.36284) 3231.1001  (1152.06628) 2344.4204  (1216.58345) 3091.7957  (1732.34795) 2449.9433  (772.66677) 4182.4869  (1751.87940) 1865.0004  (509.68268) 3176.6971  (928.32630)
2.Primary Outcome
Title Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14
Hide Description [Not Specified]
Time Frame From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description:
Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Overall Number of Participants Analyzed 9 8 7 8 11 10 9 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
39.3143  (21.34097) 61.2934  (18.14446) 46.8716  (23.07334) 63.6275  (28.29116) 44.6465  (11.48500) 77.2452  (28.49511) 37.4752  (18.26528) 63.1734  (15.08119)
3.Primary Outcome
Title Ctrough,Week 14: Observed Serum Concentration at the End of a Dosing Interval at Week 14
Hide Description [Not Specified]
Time Frame At the end of a dosing interval at Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis Set included all participants who received at least 1 dose of study drug and had at least 1 measurable concentration of vedolizumab. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description:
Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Overall Number of Participants Analyzed 8 7 8 8 11 10 10 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
9.3100  (9.48045) 10.7226  (10.35423) 8.7395  (7.77386) 10.3685  (11.30124) 16.3645  (16.93869) 21.4860  (18.01872) 3.9006  (3.62991) 7.8310  (9.44044)
4.Secondary Outcome
Title Percentage of UC Participants Who Achieve Clinical Response Based on Complete Mayo Score
Hide Description Clinical response was defined as a reduction in complete Mayo score of >= 3 points and >=30 % from Baseline with an accompanying decrease in rectal bleeding sub-score of >=1 point(s) or absolute rectal bleeding sub-score of <= 1 point. Mayo score was used in to assess UC disease activity. It consisted of 4 subscales: stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscale was scored on a scale of 0 to 3, where 0= normal condition and 3 = severe disease condition. The total Mayo score ranged from 0 to 12, with higher scores indicating more severe disease.
Time Frame Baseline (Day 1) and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title UC: <30 kg Participants, Vedolizumab 100 mg UC: <30 kg Participants, Vedolizumab 200 mg UC: >=30 kg Participants, Vedolizumab 150 mg UC: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description:
Participants with UC having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with UC having baseline weight of >=30 kg were randomized to this high dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Overall Number of Participants Analyzed 10 9 13 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
40.0
(12.2 to 73.8)
66.7
(29.9 to 92.5)
69.2
(38.6 to 90.9)
41.7
(15.2 to 72.3)
5.Secondary Outcome
Title Percentage of CD Participants Who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)
Hide Description Clinical response was defined as >=70 points decrease from Baseline in CDAI score at Week 14. The CDAI evaluated severity of signs and symptoms of CD. Information was collected on number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory, yielding 8 items that were combined with data from a 7-day diary to obtain total CDAI score. Index values of 150 and below were associated with quiescent disease; values above that indicated active disease, values >=220 indicated moderate to severe disease, and values above 450 were seen with extremely severe disease.
Time Frame Baseline (Day 1) and Week 14
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all randomized participants who received at least 1 dose of study drug. Overall number analyzed is the number of participants with data available for analyses.
Arm/Group Title CD: <30 kg Participants, Vedolizumab 100 mg CD: <30 kg Participants, Vedolizumab 200 mg CD: >=30 kg Participants, Vedolizumab 150 mg CD: >=30 kg Participants, Vedolizumab 300 mg
Hide Arm/Group Description:
Participants with CD having baseline weight of <30 kg were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of <30 kg were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Participants with CD having baseline weight of >=30 kg were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14.
Overall Number of Participants Analyzed 11 10 11 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
63.6
(30.8 to 89.1)
40.0
(12.2 to 73.8)
45.5
(16.7 to 76.6)
33.3
(9.9 to 65.1)
Time Frame From first dose of study drug up to Week 32
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety Analysis Set included all participants who received at least 1 dose of study drug. MedDRA v22.0 was used for >30 kg group and v23.0 for <30 kg group).
 
Arm/Group Title <30 kg Participants, Vedolizumab 100 mg <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 300 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
Hide Arm/Group Description Participants with UC or CD having baseline weight of <30 kg, were randomized to this low dose group and received vedolizumab 100 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC or CD having baseline weight of <30 kg, were randomized to this high dose group and received vedolizumab 200 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants from '<30 kg Participants, Vedolizumab 100 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 200 mg IV infusion at Week 14. Participants with UC or CD having baseline weight of >=30 kg, were randomized to this low dose group and received vedolizumab 150 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants with UC or CD having baseline weight of >=30 kg, were randomized to this low dose group and received vedolizumab 300 mg IV infusion on Day 1 and at Weeks 2, 6 and 14. Participants from '>=30 kg Participants, Vedolizumab 150 mg' low dose group who did not achieve Clinical Response at Week 14 were escalated to receive vedolizumab 300 mg IV infusion at Week 14.
All-Cause Mortality
<30 kg Participants, Vedolizumab 100 mg <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 300 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/19 (0.00%)   0/4 (0.00%)   0/18 (0.00%)   0/24 (0.00%)   0/6 (0.00%) 
Hide Serious Adverse Events
<30 kg Participants, Vedolizumab 100 mg <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 300 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/17 (23.53%)   6/19 (31.58%)   2/4 (50.00%)   2/18 (11.11%)   8/24 (33.33%)   1/6 (16.67%) 
Blood and lymphatic system disorders             
Anaemia  1  0/17 (0.00%)  1/19 (5.26%)  1/4 (25.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastrointestinal disorders             
Colitis ulcerative  1  0/17 (0.00%)  2/19 (10.53%)  0/4 (0.00%)  1/18 (5.56%)  3/24 (12.50%)  0/6 (0.00%) 
Crohn's disease  1  0/17 (0.00%)  3/19 (15.79%)  0/4 (0.00%)  1/18 (5.56%)  2/24 (8.33%)  0/6 (0.00%) 
Abdominal pain  1  0/17 (0.00%)  1/19 (5.26%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Colitis  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Gastrointestinal obstruction  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Small intestinal obstruction  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Infections and infestations             
Clostridium difficile infection  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Enterobacter sepsis  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Pelvic abscess  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Septic shock  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Varicella  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Bacterial infection  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Pneumonia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Staphylococcal sepsis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Viral infection  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications             
Procedural intestinal perforation  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Stoma site inflammation  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Metabolism and nutrition disorders             
Malnutrition  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Decreased appetite  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders             
Pleural mass  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA v22.0, v23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
<30 kg Participants, Vedolizumab 100 mg <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 300 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/17 (94.12%)   13/19 (68.42%)   3/4 (75.00%)   15/18 (83.33%)   20/24 (83.33%)   6/6 (100.00%) 
Blood and lymphatic system disorders             
Anaemia  1  1/17 (5.88%)  3/19 (15.79%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Lymphopenia  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  1/18 (5.56%)  2/24 (8.33%)  0/6 (0.00%) 
Microcytic anaemia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Ear and labyrinth disorders             
Ear pain  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Endocrine disorders             
Cushingoid  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Secondary adrenocortical insufficiency  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Eye disorders             
Swelling of eyelid  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Eye swelling  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Ocular hyperaemia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders             
Abdominal pain  1  5/17 (29.41%)  3/19 (15.79%)  1/4 (25.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Vomiting  1  1/17 (5.88%)  1/19 (5.26%)  2/4 (50.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Crohn's disease  1  2/17 (11.76%)  1/19 (5.26%)  0/4 (0.00%)  1/18 (5.56%)  2/24 (8.33%)  0/6 (0.00%) 
Abdominal distension  1  0/17 (0.00%)  1/19 (5.26%)  1/4 (25.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Diarrhoea  1  0/17 (0.00%)  0/19 (0.00%)  2/4 (50.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Abdominal rigidity  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Abdominal tenderness  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Abnormal faeces  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Anal fissure  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Anal fistula  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Chapped lips  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Colitis ulcerative  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  1/24 (4.17%)  0/6 (0.00%) 
Gastritis  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Lip swelling  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Melaena  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Mouth ulceration  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Nausea  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  2/6 (33.33%) 
Rectal haemorrhage  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Constipation  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  2/24 (8.33%)  0/6 (0.00%) 
Abdominal pain upper  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastrointestinal inflammation  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastrointestinal obstruction  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastrooesophageal reflux disease  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Glossodynia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Haemorrhoids  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Stomatitis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Toothache  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
General disorders             
Pyrexia  1  1/17 (5.88%)  2/19 (10.53%)  1/4 (25.00%)  0/18 (0.00%)  3/24 (12.50%)  0/6 (0.00%) 
Face oedema  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Influenza like illness  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Infusion site irritation  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Asthenia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Chest pain  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Fatigue  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Malaise  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Immune system disorders             
Allergy to arthropod sting  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Hypersensitivity  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Seasonal allergy  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Infections and infestations             
Respiratory tract infection viral  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Upper respiratory tract infection  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  1/18 (5.56%)  1/24 (4.17%)  1/6 (16.67%) 
Viral infection  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  1/18 (5.56%)  2/24 (8.33%)  1/6 (16.67%) 
Bronchitis  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  2/18 (11.11%)  0/24 (0.00%)  0/6 (0.00%) 
Ear infection  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  3/18 (16.67%)  0/24 (0.00%)  0/6 (0.00%) 
Gastroenteritis norovirus  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Hordeolum  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Influenza  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Nasopharyngitis  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  2/24 (8.33%)  1/6 (16.67%) 
Pharyngitis  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  3/24 (12.50%)  0/6 (0.00%) 
Pneumonia  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Oral herpes  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  1/6 (16.67%) 
Pharyngitis streptococcal  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  2/18 (11.11%)  0/24 (0.00%)  0/6 (0.00%) 
Clostridium difficile infection  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Fungal skin infection  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastroenteritis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Gastrointestinal candidiasis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Gastrointestinal infection  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Herpes zoster  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Infected bite  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Molluscum contagiosum  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Otitis externa  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Peritonitis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Salmonellosis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Injury, poisoning and procedural complications             
Torus fracture  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Arthropod bite  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Joint injury  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Limb injury  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Procedural dizziness  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Procedural pain  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Investigations             
C-reactive protein increased  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Blood albumin decreased  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Blood bicarbonate decreased  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Blood glucose increased  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Body temperature increased  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Clostridium test positive  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Haematocrit decreased  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Haemoglobin decreased  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  2/24 (8.33%)  0/6 (0.00%) 
Weight decreased  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Amylase increased  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Liver function test increased  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Red blood cell count decreased  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Blood calcium decreased  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Iron deficiency  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  1/24 (4.17%)  1/6 (16.67%) 
Hypoalbuminaemia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Hypophosphataemia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Weight gain poor  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  2/17 (11.76%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  2/24 (8.33%)  1/6 (16.67%) 
Back pain  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Costochondritis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Myalgia  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Pain in extremity  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Fistula discharge  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Joint swelling  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Skin papilloma  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Nervous system disorders             
Headache  1  1/17 (5.88%)  2/19 (10.53%)  0/4 (0.00%)  2/18 (11.11%)  3/24 (12.50%)  2/6 (33.33%) 
Dizziness  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  2/6 (33.33%) 
Psychiatric disorders             
Depression  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Anxiety  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Fear of injection  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Insomnia  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Renal and urinary disorders             
Nephrolithiasis  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Acute kidney injury  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Dysuria  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Proteinuria  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Reproductive system and breast disorders             
Menstruation delayed  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Vulvovaginal pruritus  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Vulvovaginal swelling  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Oropharyngeal pain  1  1/17 (5.88%)  3/19 (15.79%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  1/6 (16.67%) 
Cough  1  0/17 (0.00%)  2/19 (10.53%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  2/6 (33.33%) 
Rhinorrhoea  1  1/17 (5.88%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  1/6 (16.67%) 
Nasal congestion  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Tonsillar hypertrophy  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Upper-airway cough syndrome  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Asthma  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Dyspnoea exertional  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Skin and subcutaneous tissue disorders             
Dermatitis  1  0/17 (0.00%)  0/19 (0.00%)  1/4 (25.00%)  0/18 (0.00%)  0/24 (0.00%)  1/6 (16.67%) 
Nail bed inflammation  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Rash pruritic  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Skin lesion  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Eczema  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  1/24 (4.17%)  0/6 (0.00%) 
Miliaria  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Night sweats  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Psoriasis  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Skin exfoliation  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  1/18 (5.56%)  0/24 (0.00%)  0/6 (0.00%) 
Erythema nodosum  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
Vascular disorders             
Hot flush  1  0/17 (0.00%)  1/19 (5.26%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Pallor  1  1/17 (5.88%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  0/24 (0.00%)  0/6 (0.00%) 
Haematoma  1  0/17 (0.00%)  0/19 (0.00%)  0/4 (0.00%)  0/18 (0.00%)  1/24 (4.17%)  0/6 (0.00%) 
1
Term from vocabulary, MedDRA v22.0, v23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03138655    
Other Study ID Numbers: MLN0002-2003
2017-002231-41 ( EudraCT Number )
U1111-1174-2041 ( Other Identifier: WHO )
MLN0002-2003CTIL ( Registry Identifier: Israel )
17/NE/0257 ( Registry Identifier: NRES )
MOH_2017-09-18_000675 ( Other Identifier: CRS )
First Submitted: April 19, 2017
First Posted: May 3, 2017
Results First Submitted: November 25, 2020
Results First Posted: December 21, 2020
Last Update Posted: December 21, 2020