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    Clinical Trial Results:
    A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects with Ulcerative Colitis or Crohn’s Disease

    Summary
    EudraCT number
    		 2017-002231-41
    Trial protocol
    		 GB   DE   BE   HU   NL   PL   FR  
    Global end of trial date
    26 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Dec 2020
    First version publication date
    11 Dec 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    MLN0002-2003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03138655
    WHO universal trial number (UTN)
    		 U1111-1174-2041
    Other trial identifiers
    		 Israel: MLN0002-2003CTIL, NRES: 17/NE/0257, CRS: MOH_2017-09-18_000675
    Sponsors
    Sponsor organisation name
    Takeda Development Centre Europe, Ltd.
    Sponsor organisation address
    61 Aldwych, London, United Kingdom, WC2B 4AE
    Public contact
    Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Scientific contact
    Medical Director, Clinical Science, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000645-PIP01-09
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this trial was to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active ulcerative colitis (UC) or crohn's disease (CD).
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Nov 2017
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 5
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Hungary: 17
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Ukraine: 2
    Country: Number of subjects enrolled
    Israel: 13
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    United States: 29
    Worldwide total number of subjects
    89
    EEA total number of subjects
    44
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    46
    Adolescents (12-17 years)
    43
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    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
    Screening 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).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 UC: <30 kg Participants, Vedolizumab 100 mg
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 UC: <30 kg Participants, Vedolizumab 200 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 CD: <30 kg Participants, Vedolizumab 100 mg
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 CD: <30 kg Participants, Vedolizumab 200 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 UC: >=30 kg Participants, Vedolizumab 150 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 UC: >=30 kg Participants, Vedolizumab 300 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 CD: >=30 kg Participants, Vedolizumab 150 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Arm title
    		 CD: >=30 kg Participants, Vedolizumab 300 mg
    Arm description
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    MLN0002, ENTYVIO, KYNTELES
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab IV infusion.

    Number of subjects in period 1
    		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
    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
         Consent withdrawn by subject
    -
    1
    -
    -
    -
    -
    1
    -
         Adverse event, non-fatal
    2
    1
    2
    1
    1
    4
    2
    2
         Reason not Specified
    1
    -
    -
    2
    1
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    UC: <30 kg Participants, Vedolizumab 100 mg
    Reporting 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.

    Reporting group title
    UC: <30 kg Participants, Vedolizumab 200 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: <30 kg Participants, Vedolizumab 100 mg
    Reporting 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.

    Reporting group title
    CD: <30 kg Participants, Vedolizumab 200 mg
    Reporting group description
    		 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.

    Reporting group title
    UC: >=30 kg Participants, Vedolizumab 150 mg
    Reporting group description
    		 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.

    Reporting group title
    UC: >=30 kg Participants, Vedolizumab 300 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: >=30 kg Participants, Vedolizumab 150 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: >=30 kg Participants, Vedolizumab 300 mg
    Reporting group description
    		 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.

    Reporting group values
    		 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
    Number of subjects
    		 10 9 11 10 13 12 12 12 89
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 9 8 9 9 4 2 3 2 46
        Adolescents (12-17 years)
    		 1 1 2 1 9 10 9 10 43
    Age Continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 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) -
    Sex: Female, Male
    Units: participants
        Female
    		 4 4 4 5 5 6 8 3 39
        Male
    		 6 5 7 5 8 6 4 9 50
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 0 2 2 2 1 1 1 0 9
        Not Hispanic or Latino
    		 10 7 7 8 12 11 11 12 78
        Unknown or Not Reported
    		 0 0 2 0 0 0 0 0 2
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0 0 0 0 0
        Asian
    		 0 0 0 0 0 0 1 1 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0 0 0
        Black or African American
    		 1 2 1 0 2 0 2 0 8
        White
    		 7 7 7 9 11 10 9 11 71
        More than one race
    		 0 0 1 0 0 2 0 0 3
        Unknown or Not Reported
    		 2 0 2 1 0 0 0 0 5
    Region of Enrollment
    Units: Subjects
        Belgium
    		 1 0 0 0 0 1 2 1 5
        France
    		 0 0 1 0 0 0 0 0 1
        Hungary
    		 1 0 1 1 3 4 4 3 17
        Poland
    		 2 1 4 2 1 0 2 3 15
        United Kingdom
    		 0 0 1 1 1 0 1 2 6
        Ukraine
    		 1 1 0 0 0 0 0 0 2
        Israel
    		 3 2 0 2 3 2 0 1 13
        Canada
    		 0 0 0 0 0 0 1 0 1
        United States
    		 2 5 4 4 5 5 2 2 29
    Height
    Units: cm
        arithmetic mean (full range (min-max))
    		 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) -
    Weight
    Units: kg
        arithmetic mean (full range (min-max))
    		 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) -
    Body Mass Index (BMI)
    BMI = weight (kg) / height^2 (m^2)
    Units: kg/m^2
        arithmetic mean (full range (min-max))
    		 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) -

    End points

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    End points reporting groups
    Reporting group title
    UC: <30 kg Participants, Vedolizumab 100 mg
    Reporting 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.

    Reporting group title
    UC: <30 kg Participants, Vedolizumab 200 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: <30 kg Participants, Vedolizumab 100 mg
    Reporting 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.

    Reporting group title
    CD: <30 kg Participants, Vedolizumab 200 mg
    Reporting group description
    		 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.

    Reporting group title
    UC: >=30 kg Participants, Vedolizumab 150 mg
    Reporting group description
    		 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.

    Reporting group title
    UC: >=30 kg Participants, Vedolizumab 300 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: >=30 kg Participants, Vedolizumab 150 mg
    Reporting group description
    		 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.

    Reporting group title
    CD: >=30 kg Participants, Vedolizumab 300 mg
    Reporting group description
    		 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.

    Primary: AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14

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    End point title
    		 AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14 [1]
    End point 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. Number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses data were available for this endpoint.
    End point values
    		 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
    Number of subjects analysed
    8
    7
    7
    8
    11
    10
    9
    10
    Units: h*ng/mL
        arithmetic mean (standard deviation)
    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
    No statistical analyses for this end point

    Primary: Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14

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    End point title
    		 Cav,Week 14: Average Serum Concentration During a Dosing Interval at Week 14 [2]
    End point 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. Number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    From Day 43 (week 6) post-dose up to pre-dose Day 99 (Week 14)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses data were available for this endpoint.
    End point values
    		 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
    Number of subjects analysed
    9
    8
    7
    8
    11
    10
    9
    10
    Units: ng/mL
        arithmetic mean (standard deviation)
    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
    No statistical analyses for this end point

    Primary: Ctrough,Week 14: Observed Serum Concentration at the end of a Dosing Interval at Week 14

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    End point title
    		 Ctrough,Week 14: Observed Serum Concentration at the end of a Dosing Interval at Week 14 [3]
    End point 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. Number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    At the end of a dosing interval at Week 14
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analyses data were available for this endpoint.
    End point values
    		 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
    Number of subjects analysed
    8
    7
    8
    8
    11
    10
    10
    10
    Units: ng/mL
        arithmetic mean (standard deviation)
    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
    No statistical analyses for this end point

    Secondary: Percentage of UC Participants who Achieve Clinical Response Based on Complete Mayo Score

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    End point title
    		 Percentage of UC Participants who Achieve Clinical Response Based on Complete Mayo Score [4]
    End point 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. Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 14
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported by dose in this endpoint.
    End point values
    		 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
    Number of subjects analysed
    10
    9
    13
    12
    Units: percentage of participants
        number (confidence interval 95%)
    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)
    No statistical analyses for this end point

    Secondary: Percentage of CD Participants who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI)

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    End point title
    		 Percentage of CD Participants who Achieve Clinical Response Based on Crohn's Disease Activity Index (CDAI) [5]
    End point 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. FAS included all randomized participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Week 14
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data is reported by dose in this endpoint.
    End point values
    		 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
    Number of subjects analysed
    11
    10
    11
    12
    Units: percentage of participants
        number (confidence interval 95%)
    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)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to Week 32
    Adverse event reporting additional description
    At each visit investigator had to document any occurrence of AEs and abnormal laboratory findings.Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment.Safety Analysis Set:all participants who received >=1 dose of study drug.MedDRA v22.0: >30kg group;v23.0:<30kg group).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0 23.0
    Reporting groups
    Reporting group title
    <30 kg Participants, Vedolizumab 200 mg
    Reporting group description
    		 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.

    Reporting group title
    <30 kg Participants, Vedolizumab 100 mg
    Reporting 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.

    Reporting group title
    >=30 kg Participants, Vedolizumab 300 mg
    Reporting group description
    		 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.

    Reporting group title
    <30 kg Participants, Vedolizumab 100 mg to 200 mg
    Reporting group description
    		 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.

    Reporting group title
    >=30 kg Participants, Vedolizumab 150 mg
    Reporting group description
    		 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.

    Reporting group title
    >=30 kg Participants, Vedolizumab 150 mg to 300 mg
    Reporting group description
    		 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.

    Serious adverse events
    		 <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg >=30 kg Participants, Vedolizumab 300 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 19 (31.58%)
    4 / 17 (23.53%)
    8 / 24 (33.33%)
    2 / 4 (50.00%)
    2 / 18 (11.11%)
    1 / 6 (16.67%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stoma site inflammation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 17 (0.00%)
    3 / 24 (12.50%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 17 (0.00%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 3
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Pleural mass
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 4%
    Non-serious adverse events
    		 <30 kg Participants, Vedolizumab 200 mg <30 kg Participants, Vedolizumab 100 mg >=30 kg Participants, Vedolizumab 300 mg <30 kg Participants, Vedolizumab 100 mg to 200 mg >=30 kg Participants, Vedolizumab 150 mg >=30 kg Participants, Vedolizumab 150 mg to 300 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    13 / 19 (68.42%)
    16 / 17 (94.12%)
    20 / 24 (83.33%)
    3 / 4 (75.00%)
    15 / 18 (83.33%)
    6 / 6 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pallor
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Haematoma
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 17 (5.88%)
    3 / 24 (12.50%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    9
    1
    0
    0
    Face oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Infusion site irritation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Asthenia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Malaise
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Reproductive system and breast disorders
    Menstruation delayed
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vulvovaginal pruritus
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Vulvovaginal swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    3
    1
    1
    0
    0
    2
    Cough
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    2
    0
    1
    0
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Upper-airway cough syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Fear of injection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Investigations
    C-reactive protein increased
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Blood albumin decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    Blood bicarbonate decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Body temperature increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    Clostridium test positive
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Haematocrit decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    3
    0
    1
    0
    Weight decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Amylase increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Red blood cell count decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Blood calcium decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Torus fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Joint injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Limb injury
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Procedural dizziness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Procedural pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 17 (5.88%)
    3 / 24 (12.50%)
    0 / 4 (0.00%)
    2 / 18 (11.11%)
    2 / 6 (33.33%)
         occurrences all number
    2
    2
    4
    0
    2
    2
    Dizziness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    1
    2
    0
    0
    0
    Lymphopenia
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    3
    0
    1
    0
    Microcytic anaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Eye disorders
    Swelling of eyelid
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    3 / 19 (15.79%)
    5 / 17 (29.41%)
    1 / 24 (4.17%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    3
    8
    2
    1
    0
    0
    Vomiting
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    2 / 4 (50.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    0
    3
    1
    0
    Crohn's disease
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 17 (11.76%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    1
    2
    2
    0
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    1
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    2 / 4 (50.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    Abdominal rigidity
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Abdominal tenderness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Abnormal faeces
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Anal fissure
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Anal fistula
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Chapped lips
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Colitis ulcerative
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    Gastritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Lip swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Melaena
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Mouth ulceration
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    Rectal haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    Nail bed inflammation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Rash pruritic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    Eczema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Miliaria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Erythema nodosum
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Acute kidney injury
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Dysuria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    4
    0
    0
    0
    Proteinuria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Endocrine disorders
    Cushingoid
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Secondary adrenocortical insufficiency
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 17 (11.76%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    2
    2
    0
    0
    1
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Costochondritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    Fistula discharge
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    Infections and infestations
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    1 / 6 (16.67%)
         occurrences all number
    1
    2
    1
    0
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 17 (5.88%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    2
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    2 / 18 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    2
    0
    Ear infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    3 / 18 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    3
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    Influenza
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    2 / 24 (8.33%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    0
    2
    0
    0
    2
    Pharyngitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 17 (0.00%)
    3 / 24 (12.50%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    4
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 17 (5.88%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    2 / 18 (11.11%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Gastrointestinal candidiasis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infected bite
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Molluscum contagiosum
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Peritonitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Salmonellosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    1 / 4 (25.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Iron deficiency
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    1 / 18 (5.56%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Hypophosphataemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    0 / 24 (0.00%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Weight gain poor
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 17 (0.00%)
    1 / 24 (4.17%)
    0 / 4 (0.00%)
    0 / 18 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Apr 2017
    Amendment 1: The primary purpose of this amendment was to make following changes. • Updated administrative details • Updated exposure information • Updated to allow enrollment of of pediatric participants who weigh <30 kg
    17 Jan 2018
    Amendment 3: The primary purpose of this amendment was to make following changes. • Amended references to Study Vedolizumab-2005 to include blinded dosing • Specified that tumor necrotsis factor (TNF)-α antagonists may not be administered after participant consents to participate • Defined chronic nonsteroidal anti-inflammatory drug use • Amended the concomitant oral corticosteroid dosing information. • Added specific details regarding provision of study drug and associated supplies. • Specified that the erythrocyte sedimentation rate may be performed at a local laboratory • Removed urinalysis • Removed electrocardiogram assessments • Amended pharmacokinetic sample collection information • Amended immunogenicity sample information • Deleted pharmacogenomics assessment • Specified that no endoscopy is required if a subject withdraws before Week 6 • Amended the interim analyses information • Updated the protocol deviation information

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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