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    Clinical Trial Results:
    A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects with Ulcerative Colitis and Crohn’s Disease

    Summary
    EudraCT number
    2008-002784-14
    Trial protocol
    EE   HU   AT   SK   IE   LV   CZ   NL   IS   PT   FR   BE   ES   MT   BG   SE   IT   DE   GR   GB  
    Global end of trial date
    31 Oct 2017

    Results information
    Results version number
    v1(current)
    This version publication date
    09 Nov 2018
    First version publication date
    09 Nov 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C13008
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00790933
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    One Takeda Parkway, Deerfield, IL, United States, 60015
    Public contact
    Medical Director, Takeda, +1 8778253327, trialdisclosures@takeda.com
    Scientific contact
    Medical Director, Takeda, +1 8778253327, trialdisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Oct 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Oct 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine the safety profile of long-term vedolizumab treatment
    Protection of trial subjects
    At each visit, the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 May 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    4 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Hong Kong: 3
    Country: Number of subjects enrolled
    India: 63
    Country: Number of subjects enrolled
    Australia: 100
    Country: Number of subjects enrolled
    Malaysia: 17
    Country: Number of subjects enrolled
    New Zealand: 26
    Country: Number of subjects enrolled
    Singapore: 2
    Country: Number of subjects enrolled
    South Africa: 36
    Country: Number of subjects enrolled
    Korea, Republic of: 59
    Country: Number of subjects enrolled
    Taiwan: 4
    Country: Number of subjects enrolled
    Czech Republic: 206
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Hungary: 98
    Country: Number of subjects enrolled
    Poland: 82
    Country: Number of subjects enrolled
    Romania: 4
    Country: Number of subjects enrolled
    Serbia: 2
    Country: Number of subjects enrolled
    Slovakia: 31
    Country: Number of subjects enrolled
    Bulgaria: 11
    Country: Number of subjects enrolled
    Estonia: 14
    Country: Number of subjects enrolled
    Israel: 56
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Russian Federation: 85
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    Canada: 355
    Country: Number of subjects enrolled
    United States: 591
    Country: Number of subjects enrolled
    Austria: 25
    Country: Number of subjects enrolled
    Belgium: 175
    Country: Number of subjects enrolled
    Denmark: 2
    Country: Number of subjects enrolled
    France: 46
    Country: Number of subjects enrolled
    Germany: 44
    Country: Number of subjects enrolled
    Iceland: 6
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Netherlands: 19
    Country: Number of subjects enrolled
    Norway: 14
    Country: Number of subjects enrolled
    Spain: 5
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Switzerland: 6
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    2243
    EEA total number of subjects
    820
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    2167
    From 65 to 84 years
    76
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.

    Pre-assignment
    Screening details
    Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Vedolizumab 300 mg (C13006)
    Arm description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Intravenous Infusion

    Investigational medicinal product name
    Vedolizumab Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Matching Placebo Intravenous Infusion

    Arm title
    Vedolizumab 300 mg (C13007)
    Arm description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Matching Placebo Intravenous Infusion

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Intravenous Infusion

    Arm title
    Vedolizumab 300 mg (C13011)
    Arm description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab Matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Matching Placebo Intravenous Infusion

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Intravenous Infusion

    Arm title
    Vedolizumab 300 mg (C13004)
    Arm description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Intravenous Infusion

    Arm title
    Vedolizumab 300 mg (C13008 De Novo Participants)
    Arm description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn’s disease (CD) or ulcerative colitis (UC) not treated in a previous study.
    Arm type
    Experimental

    Investigational medicinal product name
    Vedolizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Vedolizumab Intravenous Infusion

    Number of subjects in period 1
    Vedolizumab 300 mg (C13006) Vedolizumab 300 mg (C13007) Vedolizumab 300 mg (C13011) Vedolizumab 300 mg (C13004) Vedolizumab 300 mg (C13008 De Novo Participants)
    Started
    675
    726
    384
    37
    421
    Completed
    237
    246
    115
    23
    145
    Not completed
    438
    480
    269
    14
    276
         Study Terminated by Sponsor
    -
    -
    1
    -
    -
         Lack of efficacy
    192
    176
    130
    1
    121
         Reason Not Specified
    8
    16
    4
    1
    9
         Protocol Violation(s)
    8
    18
    7
    -
    12
         Adverse event, non-fatal
    94
    119
    65
    5
    69
         Consent withdrawn by subject
    123
    120
    52
    6
    50
         Lost to follow-up
    13
    31
    10
    1
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Vedolizumab 300 mg (C13006)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.

    Reporting group title
    Vedolizumab 300 mg (C13007)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.

    Reporting group title
    Vedolizumab 300 mg (C13011)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Reporting group title
    Vedolizumab 300 mg (C13004)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.

    Reporting group title
    Vedolizumab 300 mg (C13008 De Novo Participants)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn’s disease (CD) or ulcerative colitis (UC) not treated in a previous study.

    Reporting group values
    Vedolizumab 300 mg (C13006) Vedolizumab 300 mg (C13007) Vedolizumab 300 mg (C13011) Vedolizumab 300 mg (C13004) Vedolizumab 300 mg (C13008 De Novo Participants) Total
    Number of subjects
    675 726 384 37 421 2243
    Age, Customized
    Units: Subjects
        <65
    646 710 376 35 400 2167
        >=65
    29 16 8 2 21 76
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    41.2 ± 13.27 37.3 ± 12.26 38.3 ± 12.87 43.9 ± 14.24 39.3 ± 14.23 -
    Sex: Female, Male
    Units: Subjects
        Female
    280 384 216 20 215 1115
        Male
    395 342 168 17 206 1128
    Race/Ethnicity, Customized
    Units: Subjects
        White
    557 641 349 36 398 1981
        Black
    10 17 7 0 8 42
        Native Hawaiian or Other Pacific Islander
    2 0 1 0 0 3
        Asian
    98 66 14 0 9 187
        American Indian or Alaskan Native
    2 0 0 1 0 3
        Other
    6 2 11 0 5 24
        Not Reported
    0 0 2 0 1 3
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    29 12 7 0 19 67
        Not Hispanic or Latino
    631 700 372 36 400 2139
        Unknown or Not Reported
    15 14 5 1 2 37
    Region of Enrollment
    Units: Subjects
        Australia
    41 30 8 0 21 100
        Hong Kong
    1 2 0 0 0 3
        India
    39 24 0 0 0 63
        Malaysia
    8 6 3 0 0 17
        New Zealand
    9 8 1 0 8 26
        Singapore
    1 1 0 0 0 2
        South Africa
    13 15 8 0 0 36
        Korea, Republic Of
    34 18 7 0 0 59
        Taiwan, Province Of China
    1 3 0 0 0 4
        Czech Republic
    34 67 36 0 69 206
        Greece
    5 0 0 0 0 5
        Hungary
    12 47 22 0 17 98
        Poland
    53 20 9 0 0 82
        Romania
    0 4 0 0 0 4
        Serbia
    0 2 0 0 0 2
        Slovakia
    0 14 17 0 0 31
        Bulgaria
    5 6 0 0 0 11
        Estonia
    9 5 0 0 0 14
        Israel
    2 12 21 0 21 56
        Latvia
    0 1 0 0 0 1
        Russia
    46 24 0 15 0 85
        Turkey
    6 3 0 0 0 9
        Ukraine
    0 9 0 0 0 9
        Canada
    73 98 75 22 87 355
        United States
    169 166 109 0 147 591
        Austria
    13 9 3 0 0 25
        Belgium
    48 48 33 0 46 175
        Denmark
    2 0 0 0 0 2
        France
    11 25 10 0 0 46
        Germany
    10 25 4 0 5 44
        Iceland
    3 3 0 0 0 6
        Ireland
    1 1 0 0 0 2
        Italy
    12 7 4 0 0 23
        Netherlands
    2 5 12 0 0 19
        Norway
    7 5 2 0 0 14
        Spain
    1 4 0 0 0 5
        Sweden
    0 5 0 0 0 5
        Switzerland
    2 4 0 0 0 6
        United Kingdom
    2 0 0 0 0 2
    Body Weight
    Units: kg
        arithmetic mean (standard deviation)
    74.10 ± 17.934 71.70 ± 19.600 71.29 ± 18.951 77.66 ± 18.907 75.45 ± 18.814 -
    BMI
    Body Mass Index = weight (kg)/[height (m)^2]. 999999 = BMI was not calculated for de novo participants as height was not collected for these participants. BMI data was available for only 1822 participants.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    25.39 ± 5.391 24.61 ± 6.039 24.56 ± 5.783 27.11 ± 6.523 999999 ± 999999 -

    End points

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    End points reporting groups
    Reporting group title
    Vedolizumab 300 mg (C13006)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab every 8 weeks (Q8W), IV infusion up to Week 52.

    Reporting group title
    Vedolizumab 300 mg (C13007)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52.

    Reporting group title
    Vedolizumab 300 mg (C13011)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Reporting group title
    Vedolizumab 300 mg (C13004)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78.

    Reporting group title
    Vedolizumab 300 mg (C13008 De Novo Participants)
    Reporting group description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn’s disease (CD) or ulcerative colitis (UC) not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (UC)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis (UC).

    Subject analysis set title
    Vedolizumab 300 mg (CD)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.

    Subject analysis set title
    Vedolizumab 300 mg (UC)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004 and C13006 with a diagnosis of Ulcerative colitis.

    Subject analysis set title
    Vedolizumab 300 mg (CD)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks. Includes De Novo participants and participants previously enrolled in studies C13004, C13007 and C13011 with a diagnosis of Crohn's disease.

    Subject analysis set title
    Vedolizumab 300 mg
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab matching placebo, IV infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction phase up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, IV infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Vedolizumab)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately up to 315 weeks including treatment in the previous study. In study C13011: vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, starting at Week 0, up to approximately 260 weeks in participants with Crohn’s disease not treated in a previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab matching placebo, intravenous infusion at Weeks 0 and 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13011 Placebo)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: vedolizumab matching placebo, IV infusion at Weeks 0, 2 and 6.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Week 0 and Week 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 50.

    Subject analysis set title
    Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q4W up to Week 52.

    Subject analysis set title
    Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W, up to approximately 260 weeks in participants with ulcerative colitis not treated in previous study.

    Subject analysis set title
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: vedolizumab 300 mg, intravenous infusion at Weeks 0 and 2 (Days 1 and 15) in Induction Phase. In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria received vedolizumab, IV infusion, Q8W up to Week 50.

    Primary: Percentage of Participants with One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    Percentage of Participants with One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [1]
    End point description
    An AE is defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (eg, clinically significant abnormal laboratory finding)/symptom/disease temporally associated with use of drug, whether or not it is considered related to drug. TEAE is defined as an AE with onset that occurs after receiving study drug. SAE is any experience that suggests significant hazard, contraindication, side effect or precaution that results in death, is life-threatening, required in-patient hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. Safety population, participants who participated in Studies C13004, C13006, C13007, C13011 and De Novo participants who received vedolizumab in Study C13008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
    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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
    Number of subjects analysed
    894
    1349
    Units: percentage of participants
        TEAEs
    93
    96
        SAEs
    31
    41
    No statistical analyses for this end point

    Primary: Number of Participants with Markedly Abnormal Safety Laboratory Findings

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    End point title
    Number of Participants with Markedly Abnormal Safety Laboratory Findings [2]
    End point description
    A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin <= 70 g/L, absolute lymphocyte count <0.5 X 10^9/L, leukocytes <2.0 X 10^9/L (absolute value), platelets <75.0 X 10^9/L, absolute neutrophil Count <1.0 X 10^9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0 x ULN, aspartate aminotransferase (AST) >3.0 x ULN, bilirubin >2.0 x ULN, amylase >2.0 x ULN, lipase >2.0 x ULN. Safety population, participants who participated in Studies C13004, C13006, C13007, C13011 and De Novo participants who received vedolizumab in Study C13008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
    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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
    Number of subjects analysed
    894
    1349
    Units: participants
        Hemoglobin <= 70 g/L
    16
    11
        Absolute Lymphocyte Count <0.5 X 10^9/L
    28
    56
        Leukocytes <2.0 X 10^9/L (Absolute Value)
    1
    3
        Platelets <75.0 X 10^9/L
    2
    5
        Absolute Neutrophil Count <1.0 X 10^9/L
    9
    9
        Prothrombin Time >1.25 x ULN
    42
    37
        ALT >3.0 x ULN
    30
    47
        AST >3.0 x ULN
    35
    34
        Bilirubin >2.0 x ULN
    12
    14
        Amylase >2.0 x ULN
    16
    36
        Lipase >2.0 x ULN
    27
    41
    No statistical analyses for this end point

    Primary: Percentage of Participants with Clinically Significant Mean Change Over Time in Vital Sign Measurements

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    End point title
    Percentage of Participants with Clinically Significant Mean Change Over Time in Vital Sign Measurements [3]
    End point description
    Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE. Safety population, participants who participated in Studies C13004, C13006, C13007, C13011 and De Novo participants who received vedolizumab in Study C13008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
    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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
    Number of subjects analysed
    894
    1349
    Units: percentage of participants
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings

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    End point title
    Number of Participants with Clinically Significant Electrocardiogram (ECG) Findings [4]
    End point description
    A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs. Safety population, participants who participated in Studies C13004, C13006, C13007, C13011 and De Novo participants who received vedolizumab in Study C13008.
    End point type
    Primary
    End point timeframe
    From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
    Notes
    [4] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (UC) Vedolizumab 300 mg (CD)
    Number of subjects analysed
    894
    1349
    Units: participants
    7
    7
    No statistical analyses for this end point

    Primary: Time to Major Inflammatory Bowel Disease (IBD) - Related Events

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    End point title
    Time to Major Inflammatory Bowel Disease (IBD) - Related Events [5]
    End point description
    IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease. Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement. Here, 9999=Median and Confidence Interval was not estimable due to the low number of participants with events.
    End point type
    Primary
    End point timeframe
    Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)
    Notes
    [5] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg
    Number of subjects analysed
    2142
    Units: weeks
    median (confidence interval 95%)
        IBD-related events, UC
    9999 (9999 to 9999)
        IBD-related events, CD
    9999 (9999 to 9999)
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 [6]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). Total IBDQ score is calculated by summing scores from each domain; Total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
    Notes
    [6] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    38
    67
    76
    52
    62
    71
    127
    134
    150
    161
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    125.34 ± 34.895
    129.12 ± 34.289
    124.37 ± 31.632
    122.33 ± 31.114
    127.56 ± 33.718
    127.11 ± 30.537
    123.88 ± 31.620
    124.35 ± 33.310
    131.44 ± 27.715
    132.14 ± 32.245
        Change at Week 28
    60.00 ± 41.165
    62.71 ± 34.600
    62.53 ± 35.072
    57.17 ± 38.851
    57.52 ± 42.561
    51.48 ± 34.576
    41.71 ± 36.508
    40.49 ± 39.733
    42.90 ± 32.581
    30.84 ± 34.614
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 [7]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
    Notes
    [7] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    32
    65
    70
    49
    56
    63
    107
    117
    132
    134
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    123.53 ± 36.160
    131.17 ± 33.675
    125.03 ± 32.560
    120.29 ± 30.894
    129.46 ± 34.799
    128.69 ± 30.461
    125.30 ± 30.075
    125.31 ± 34.140
    130.63 ± 28.446
    132.71 ± 33.108
        Change at Week 52
    66.84 ± 41.733
    59.89 ± 33.170
    61.06 ± 37.386
    59.31 ± 34.837
    58.87 ± 40.707
    52.30 ± 29.385
    44.31 ± 37.923
    47.38 ± 37.687
    47.07 ± 30.463
    37.33 ± 40.232
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 [8]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
    Notes
    [8] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    29
    63
    63
    45
    55
    58
    91
    106
    118
    113
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    123.66 ± 36.115
    131.31 ± 33.726
    123.87 ± 31.752
    120.00 ± 29.667
    128.47 ± 34.724
    129.06 ± 31.694
    124.89 ± 31.629
    125.89 ± 34.478
    130.75 ± 28.587
    132.46 ± 33.245
        Change at Week 76
    65.53 ± 40.584
    59.88 ± 35.290
    64.27 ± 32.443
    59.91 ± 34.449
    55.05 ± 47.181
    52.85 ± 36.486
    47.43 ± 35.811
    46.32 ± 36.397
    50.59 ± 30.794
    40.14 ± 39.305
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 [9]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
    Notes
    [9] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    45
    27
    58
    58
    49
    55
    84
    96
    112
    104
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    120.89 ± 29.745
    124.70 ± 37.614
    130.90 ± 34.361
    124.52 ± 30.033
    129.53 ± 35.261
    128.25 ± 32.333
    123.50 ± 29.662
    128.35 ± 33.793
    132.41 ± 28.538
    132.48 ± 32.305
        Change at Week 100
    57.04 ± 38.448
    61.83 ± 41.505
    62.46 ± 32.502
    62.83 ± 34.475
    58.53 ± 45.644
    53.40 ± 32.651
    49.89 ± 36.806
    46.95 ± 34.691
    52.50 ± 32.267
    38.52 ± 36.982
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 [10]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
    Notes
    [10] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    54
    43
    47
    48
    80
    82
    95
    97
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    127.33 ± 36.470
    130.83 ± 34.399
    123.65 ± 30.180
    119.77 ± 29.963
    132.36 ± 34.573
    130.01 ± 33.454
    122.91 ± 29.869
    129.08 ± 33.576
    132.75 ± 28.131
    131.56 ± 31.567
        Change at Week 124
    63.94 ± 44.480
    60.94 ± 37.769
    63.71 ± 34.542
    61.91 ± 36.288
    53.91 ± 44.023
    53.74 ± 34.514
    46.62 ± 38.435
    47.60 ± 40.634
    54.47 ± 29.636
    40.35 ± 41.543
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 [11]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
    Notes
    [11] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    54
    53
    41
    43
    46
    76
    83
    93
    92
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    127.33 ± 36.470
    131.95 ± 34.649
    123.02 ± 29.685
    119.07 ± 30.344
    132.23 ± 35.877
    130.25 ± 34.108
    122.01 ± 28.967
    128.66 ± 34.624
    133.36 ± 28.616
    132.38 ± 32.172
        Change at Week 148
    60.66 ± 41.786
    62.72 ± 33.786
    65.81 ± 33.232
    60.41 ± 36.074
    54.53 ± 48.036
    56.08 ± 32.954
    52.30 ± 39.123
    49.40 ± 36.880
    54.50 ± 32.874
    42.13 ± 40.030
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 [12]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
    Notes
    [12] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    43
    24
    53
    49
    37
    43
    71
    76
    89
    80
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    131.60 ± 36.013
    130.25 ± 36.650
    132.93 ± 34.216
    123.47 ± 30.141
    120.49 ± 30.221
    132.31 ± 33.860
    120.70 ± 27.535
    127.42 ± 34.779
    133.34 ± 28.981
    131.69 ± 32.229
        Change at Week 172
    54.91 ± 40.758
    58.67 ± 42.513
    62.20 ± 33.187
    62.16 ± 33.969
    65.43 ± 35.350
    53.92 ± 33.132
    51.55 ± 40.714
    47.97 ± 35.121
    56.02 ± 33.863
    41.18 ± 40.805
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 [13]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
    Notes
    [13] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    37
    50
    46
    41
    41
    66
    71
    62
    51
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    127.33 ± 36.470
    119.35 ± 31.651
    135.33 ± 33.596
    122.00 ± 30.129
    130.39 ± 36.410
    132.16 ± 34.217
    121.15 ± 28.703
    126.44 ± 34.826
    136.55 ± 27.551
    137.27 ± 30.844
        Change at Week 196
    63.19 ± 38.061
    64.81 ± 36.563
    59.13 ± 33.318
    68.89 ± 34.578
    58.90 ± 46.107
    55.67 ± 32.453
    52.22 ± 42.363
    49.41 ± 35.662
    49.05 ± 30.390
    36.35 ± 41.424
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 [14]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
    Notes
    [14] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    21
    38
    36
    32
    32
    31
    38
    45
    3
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    116.05 ± 31.747
    133.61 ± 32.538
    120.28 ± 30.875
    116.63 ± 32.888
    131.81 ± 35.906
    129.37 ± 31.455
    122.00 ± 27.231
    125.93 ± 35.080
    127.00 ± 63.930
    128.00 ± 35.749
        Change at Week 248
    76.21 ± 38.693
    57.52 ± 31.841
    69.56 ± 38.680
    65.72 ± 34.776
    54.97 ± 41.658
    58.76 ± 35.250
    51.39 ± 45.950
    53.04 ± 38.830
    73.00 ± 48.446
    72.00 ± 32.156
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 [15]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
    Notes
    [15] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
    Number of subjects analysed
    7
    14
    13
    9
    8
    16
    4
    2
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    100.71 ± 21.831
    137.50 ± 30.478
    120.38 ± 24.401
    119.67 ± 33.463
    134.88 ± 36.957
    121.38 ± 30.133
    120.25 ± 19.085
    162.50 ± 47.376
        Change at Week 300
    94.29 ± 38.612
    55.43 ± 41.694
    67.54 ± 27.823
    69.00 ± 41.192
    53.00 ± 41.542
    72.00 ± 35.219
    73.50 ± 12.342
    2.00 ± 5.657
    No statistical analyses for this end point

    Primary: Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352

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    End point title
    Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 [16]
    End point description
    IBDQ is an instrument used to assess quality of life in adult participants with IBD. It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing scores from each domain; total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies at both Baseline and Week 352. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. Here, 9999=Standard deviation (SD) was not calculated for 1 participant.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
    Notes
    [16] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Number of subjects analysed
    1
    1
    3
    1
    2
    1
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    89.00 ± 9999
    120.00 ± 9999
    118.00 ± 32.047
    70.00 ± 9999
    137.00 ± 28.284
    126.00 ± 9999
        Change at Week 352
    123.00 ± 9999
    86.00 ± 9999
    66.00 ± 33.181
    131.00 ± 9999
    37.50 ± 28.991
    84.00 ± 9999
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 [17]
    End point description
    Short Form-36 (SF-36) is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary(PCS)score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg(C13004)arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
    Notes
    [17] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    38
    67
    76
    52
    62
    71
    127
    136
    151
    162
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.57 ± 8.599
    41.15 ± 8.313
    40.05 ± 7.634
    37.05 ± 7.522
    37.87 ± 8.113
    39.09 ± 7.771
    37.92 ± 8.355
    36.81 ± 8.274
    40.06 ± 8.631
    39.20 ± 7.306
        Change at Week 28
    10.20 ± 8.792
    8.22 ± 9.015
    8.89 ± 7.110
    9.85 ± 8.789
    12.46 ± 8.900
    9.60 ± 7.620
    6.48 ± 8.514
    7.74 ± 9.310
    7.07 ± 8.752
    5.67 ± 7.695
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 [18]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
    Notes
    [18] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    38
    67
    76
    52
    62
    71
    127
    136
    151
    162
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.98 ± 11.349
    40.70 ± 11.226
    38.28 ± 11.039
    35.49 ± 11.139
    38.53 ± 10.631
    37.70 ± 12.423
    36.60 ± 11.545
    38.04 ± 12.567
    40.87 ± 11.385
    39.29 ± 11.535
        Change at Week 28
    8.36 ± 13.096
    11.10 ± 11.098
    11.52 ± 12.464
    13.35 ± 11.857
    10.88 ± 12.396
    10.94 ± 12.386
    7.48 ± 12.061
    6.34 ± 13.161
    6.48 ± 10.809
    3.72 ± 12.377
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 [19]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
    Notes
    [19] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    32
    49
    56
    63
    107
    64
    69
    118
    133
    135
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.94 ± 8.930
    36.75 ± 7.510
    37.82 ± 8.301
    39.23 ± 7.807
    37.87 ± 7.992
    41.72 ± 8.314
    40.12 ± 7.694
    37.40 ± 8.171
    40.51 ± 8.454
    39.27 ± 7.469
        Change at Week 52
    9.55 ± 10.155
    9.43 ± 9.088
    12.97 ± 9.147
    9.98 ± 7.824
    7.48 ± 8.800
    8.57 ± 7.889
    9.77 ± 6.766
    8.97 ± 8.743
    8.37 ± 8.401
    6.72 ± 7.842
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 [20]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
    Notes
    [20] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    32
    49
    56
    63
    107
    64
    69
    118
    133
    135
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.33 ± 11.878
    35.43 ± 11.445
    39.45 ± 9.910
    38.98 ± 11.963
    36.80 ± 11.052
    41.18 ± 11.150
    38.29 ± 11.062
    38.54 ± 12.379
    40.32 ± 11.333
    39.16 ± 11.518
        Change at Week 52
    10.27 ± 12.895
    12.68 ± 11.843
    10.54 ± 11.719
    8.40 ± 11.598
    8.27 ± 11.770
    10.40 ± 10.777
    12.18 ± 11.506
    7.86 ± 13.129
    6.71 ± 10.363
    6.23 ± 12.306
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component at Week 76

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component at Week 76 [21]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
    Notes
    [21] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    29
    63
    63
    45
    55
    58
    106
    90
    120
    114
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.79 ± 8.801
    41.33 ± 8.517
    40.07 ± 7.625
    37.03 ± 7.675
    37.92 ± 8.353
    39.59 ± 7.809
    37.47 ± 8.147
    37.53 ± 8.286
    40.73 ± 8.552
    39.25 ± 7.667
        Change at Week 76
    9.69 ± 9.714
    8.97 ± 8.891
    10.54 ± 6.416
    10.48 ± 7.797
    11.98 ± 9.496
    10.28 ± 7.651
    8.82 ± 8.501
    7.77 ± 8.397
    9.73 ± 8.461
    7.31 ± 8.436
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 [22]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
    Notes
    [22] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    29
    63
    63
    45
    55
    58
    106
    90
    120
    114
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.41 ± 11.201
    41.30 ± 10.710
    38.26 ± 10.974
    35.50 ± 11.582
    38.86 ± 10.046
    38.52 ± 12.244
    39.03 ± 12.679
    36.68 ± 11.947
    40.32 ± 11.673
    39.16 ± 11.712
        Change at Week 76
    9.64 ± 14.272
    8.52 ± 11.462
    10.51 ± 12.334
    12.92 ± 13.174
    8.02 ± 14.020
    9.13 ± 13.719
    8.26 ± 12.809
    8.27 ± 12.720
    7.77 ± 10.989
    7.16 ± 13.144
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 [23]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
    Notes
    [23] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    45
    27
    58
    58
    49
    84
    96
    54
    114
    105
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    36.97 ± 7.677
    41.26 ± 8.825
    41.03 ± 8.260
    40.29 ± 7.480
    38.11 ± 8.169
    37.26 ± 7.974
    37.90 ± 8.297
    39.59 ± 7.989
    41.13 ± 8.579
    39.28 ± 7.458
        Change at Week 100
    11.18 ± 8.322
    10.28 ± 8.418
    9.41 ± 7.934
    9.42 ± 7.556
    12.97 ± 9.396
    8.47 ± 8.096
    9.45 ± 8.747
    10.78 ± 8.926
    9.70 ± 8.869
    7.40 ± 8.473
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 [24]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
    Notes
    [24] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    45
    27
    58
    58
    49
    84
    96
    54
    114
    105
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    35.61 ± 11.568
    39.56 ± 11.833
    41.10 ± 11.140
    38.21 ± 10.885
    38.76 ± 10.215
    36.61 ± 11.894
    39.43 ± 12.474
    37.41 ± 11.857
    40.39 ± 11.559
    39.04 ± 11.604
        Change at Week 100
    10.64 ± 13.629
    8.80 ± 14.395
    9.87 ± 10.552
    10.82 ± 12.303
    8.94 ± 13.798
    8.25 ± 12.562
    7.93 ± 11.053
    9.98 ± 11.450
    7.66 ± 10.685
    6.94 ± 13.189
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 [25]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
    Notes
    [25] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    54
    43
    47
    48
    80
    83
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    41.75 ± 7.947
    41.08 ± 8.219
    39.88 ± 7.332
    37.00 ± 7.854
    38.58 ± 8.078
    39.31 ± 8.279
    37.09 ± 8.044
    38.36 ± 8.240
    41.10 ± 8.747
    39.01 ± 7.363
        Change at Week 124
    10.12 ± 9.685
    7.91 ± 9.483
    10.15 ± 8.551
    11.79 ± 8.053
    12.87 ± 8.803
    11.01 ± 8.319
    8.36 ± 7.495
    7.77 ± 9.228
    10.56 ± 8.804
    9.27 ± 8.274
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 [26]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
    Notes
    [26] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    54
    43
    47
    48
    80
    83
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    40.34 ± 12.065
    40.81 ± 11.132
    37.85 ± 11.106
    35.29 ± 11.668
    38.59 ± 9.956
    38.33 ± 12.409
    39.04 ± 12.421
    36.64 ± 11.938
    40.87 ± 11.156
    38.90 ± 11.427
        Change at Week 124
    9.53 ± 16.289
    10.02 ± 10.734
    9.70 ± 12.781
    11.35 ± 12.681
    9.20 ± 12.521
    10.38 ± 13.230
    8.50 ± 12.808
    8.78 ± 13.283
    7.73 ± 11.048
    6.26 ± 13.274
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 [27]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
    Notes
    [27] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    82
    53
    43
    46
    76
    40
    20
    24
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    41.75 ± 7.947
    41.33 ± 8.438
    37.99 ± 8.430
    39.86 ± 7.312
    39.22 ± 7.511
    39.21 ± 8.303
    36.94 ± 8.087
    36.68 ± 8.055
    43.32 ± 10.405
    38.77 ± 7.024
        Change at Week 148
    9.08 ± 9.090
    9.35 ± 8.228
    8.94 ± 8.442
    10.34 ± 6.524
    12.54 ± 9.695
    11.26 ± 7.231
    9.37 ± 8.223
    12.15 ± 9.941
    9.81 ± 8.727
    10.39 ± 6.824
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 [28]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
    Notes
    [28] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    82
    54
    53
    43
    46
    76
    40
    20
    24
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    40.34 ± 12.065
    39.36 ± 12.612
    41.20 ± 11.115
    37.48 ± 11.101
    38.56 ± 10.221
    39.21 ± 12.368
    36.71 ± 12.021
    35.05 ± 11.782
    42.40 ± 8.427
    41.67 ± 10.953
        Change at Week 148
    6.89 ± 14.522
    8.26 ± 12.835
    9.79 ± 11.176
    11.09 ± 12.299
    9.27 ± 11.720
    9.81 ± 12.524
    8.91 ± 12.680
    10.47 ± 12.517
    6.44 ± 12.279
    6.85 ± 12.118
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 [29]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
    Notes
    [29] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    43
    53
    49
    37
    43
    71
    25
    75
    91
    81
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    38.82 ± 8.231
    41.52 ± 8.401
    40.23 ± 6.713
    37.29 ± 8.057
    39.16 ± 8.177
    36.92 ± 8.023
    42.23 ± 8.073
    37.85 ± 8.538
    41.12 ± 9.029
    39.30 ± 7.264
        Change at Week 172
    13.21 ± 9.194
    9.20 ± 8.324
    9.68 ± 6.804
    11.83 ± 8.042
    10.88 ± 7.837
    9.61 ± 8.461
    10.08 ± 8.996
    9.07 ± 7.519
    10.47 ± 8.921
    8.55 ± 8.546
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 [30]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
    Notes
    [30] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    43
    53
    49
    37
    43
    71
    25
    75
    91
    81
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    38.77 ± 10.268
    41.49 ± 11.015
    37.00 ± 10.963
    35.47 ± 11.757
    39.83 ± 12.249
    36.64 ± 11.938
    40.79 ± 12.254
    39.01 ± 12.258
    40.98 ± 11.479
    38.85 ± 11.972
        Change at Week 172
    9.12 ± 14.244
    10.37 ± 10.420
    9.57 ± 12.850
    12.84 ± 12.281
    8.45 ± 13.317
    8.78 ± 13.283
    7.43 ± 12.227
    7.52 ± 12.609
    8.66 ± 10.767
    7.48 ± 12.329
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 [31]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
    Notes
    [31] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
    Number of subjects analysed
    16
    33
    29
    31
    27
    33
    19
    21
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    40.72 ± 7.823
    40.83 ± 8.135
    40.52 ± 7.242
    35.64 ± 7.862
    36.65 ± 9.250
    39.33 ± 8.136
    39.53 ± 7.830
    38.40 ± 9.680
        Change at Week 196
    11.82 ± 9.370
    9.98 ± 7.569
    9.31 ± 5.771
    12.35 ± 8.867
    14.10 ± 10.616
    11.75 ± 8.261
    6.94 ± 8.667
    9.83 ± 8.111
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 [32]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
    Notes
    [32] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
    Number of subjects analysed
    16
    33
    29
    31
    27
    33
    19
    21
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.46 ± 13.424
    42.74 ± 10.517
    40.40 ± 9.771
    36.17 ± 12.536
    39.07 ± 10.804
    37.63 ± 12.199
    40.11 ± 10.932
    40.05 ± 13.807
        Change at Week 196
    9.37 ± 12.087
    9.43 ± 9.349
    9.79 ± 11.516
    12.62 ± 14.386
    10.05 ± 15.471
    9.26 ± 12.732
    8.59 ± 14.645
    9.75 ± 14.824
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 [33]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
    Notes
    [33] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    21
    38
    36
    32
    32
    31
    38
    45
    3
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    39.99 ± 7.219
    40.71 ± 7.605
    39.33 ± 6.820
    37.54 ± 8.054
    38.32 ± 8.047
    40.28 ± 8.878
    37.95 ± 8.232
    37.77 ± 8.654
    39.17 ± 13.987
    38.79 ± 7.735
        Change at Week 248
    11.22 ± 10.562
    9.95 ± 8.355
    11.43 ± 8.047
    11.70 ± 6.541
    13.88 ± 8.511
    9.98 ± 9.027
    9.32 ± 9.261
    10.50 ± 8.803
    15.98 ± 7.868
    9.88 ± 6.977
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 [34]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
    Notes
    [34] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    21
    38
    36
    32
    32
    31
    38
    45
    3
    4
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    38.00 ± 12.537
    41.76 ± 10.579
    38.01 ± 10.876
    34.26 ± 12.252
    38.06 ± 10.300
    38.04 ± 11.320
    36.41 ± 13.568
    36.77 ± 12.333
    38.65 ± 18.372
    31.20 ± 4.603
        Change at Week 248
    11.99 ± 13.421
    6.13 ± 9.986
    10.41 ± 13.081
    12.70 ± 12.140
    9.84 ± 11.433
    10.61 ± 11.204
    7.37 ± 16.473
    10.61 ± 12.188
    7.64 ± 18.599
    15.98 ± 13.355
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 [35]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
    Notes
    [35] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
    Number of subjects analysed
    7
    14
    13
    9
    8
    16
    4
    2
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    36.89 ± 5.913
    38.84 ± 7.720
    39.22 ± 5.469
    36.56 ± 8.514
    34.80 ± 8.431
    39.97 ± 6.626
    41.04 ± 12.016
    34.80 ± 10.515
        Change at Week 300
    12.03 ± 10.338
    10.58 ± 8.335
    11.15 ± 6.497
    15.47 ± 9.920
    14.42 ± 6.749
    10.69 ± 6.448
    9.10 ± 9.330
    6.41 ± 9.023
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 [36]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
    Notes
    [36] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab)
    Number of subjects analysed
    7
    14
    13
    9
    8
    16
    4
    2
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    34.53 ± 12.530
    43.55 ± 9.074
    35.77 ± 8.585
    33.38 ± 11.168
    39.40 ± 11.144
    35.79 ± 12.157
    31.35 ± 13.760
    46.99 ± 7.729
        Change at Week 300
    21.86 ± 13.935
    4.82 ± 10.738
    9.82 ± 11.463
    13.46 ± 15.324
    6.31 ± 11.916
    14.79 ± 15.281
    19.87 ± 6.588
    -3.67 ± 20.577
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 [37]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. Here, 9999=SD was not calculated for 1 participant.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
    Notes
    [37] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Number of subjects analysed
    1
    1
    3
    1
    2
    1
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    35.68 ± 9999
    38.32 ± 9999
    44.36 ± 0.920
    31.07 ± 9999
    37.14 ± 3.711
    33.67 ± 9999
        Change at Week 352
    17.97 ± 9999
    17.87 ± 9999
    5.06 ± 5.188
    24.06 ± 9999
    11.18 ± 2.116
    18.02 ± 9999
    No statistical analyses for this end point

    Primary: Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352

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    End point title
    Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 [38]
    End point description
    SF-36 is a questionnaire that evaluates a person’s HRQOL. It includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary(MCS)score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies at both Baseline and Week 352. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. Here, 9999=SD was not calculated for 1 participant.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
    Notes
    [38] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W)
    Number of subjects analysed
    1
    1
    3
    1
    2
    1
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    42.19 ± 9999
    35.34 ± 9999
    32.72 ± 7.252
    22.18 ± 9999
    39.80 ± 14.563
    42.98 ± 9999
        Change at Week 352
    17.40 ± 9999
    19.87 ± 9999
    14.14 ± 10.114
    25.04 ± 9999
    8.65 ± 7.463
    13.08 ± 9999
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 [39]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
    Notes
    [39] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13011 Placebo)
    Number of subjects analysed
    38
    67
    76
    52
    62
    71
    136
    151
    162
    126
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.42 ± 1.328
    7.21 ± 1.354
    7.54 ± 1.399
    8.00 ± 1.559
    7.77 ± 1.442
    7.73 ± 1.434
    7.85 ± 1.525
    7.30 ± 1.360
    7.48 ± 1.420
    7.67 ± 1.475
        Change at Week 28
    -1.29 ± 1.873
    -1.03 ± 1.705
    -1.44 ± 1.568
    -1.65 ± 1.867
    -1.82 ± 1.675
    -1.46 ± 1.510
    -0.90 ± 1.634
    -0.96 ± 1.380
    -0.69 ± 1.493
    -0.75 ± 1.648
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 [40]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
    Notes
    [40] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    38
    67
    52
    62
    75
    70
    125
    135
    149
    157
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    58.4 ± 20.96
    62.1 ± 16.54
    51.5 ± 17.57
    52.2 ± 18.72
    53.5 ± 17.30
    52.3 ± 18.39
    53.2 ± 18.02
    51.3 ± 19.09
    56.4 ± 19.64
    55.6 ± 16.72
        Change at Week 28
    22.7 ± 24.11
    20.0 ± 18.75
    23.8 ± 23.79
    27.6 ± 22.58
    25.1 ± 22.09
    23.7 ± 22.51
    16.8 ± 22.55
    19.9 ± 22.44
    17.1 ± 21.75
    13.4 ± 19.48
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 [41]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
    Notes
    [41] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13007 Placebo)
    Number of subjects analysed
    32
    65
    70
    56
    63
    107
    118
    133
    135
    48
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.50 ± 1.368
    7.17 ± 1.318
    7.54 ± 1.390
    7.75 ± 1.468
    7.65 ± 1.358
    7.62 ± 1.398
    7.74 ± 1.538
    7.33 ± 1.386
    7.49 ± 1.429
    8.08 ± 1.499
        Change at Week 52
    -1.59 ± 1.775
    -1.00 ± 1.571
    -1.43 ± 1.556
    -1.77 ± 1.640
    -1.46 ± 1.457
    -0.87 ± 1.666
    -1.15 ± 1.703
    -0.95 ± 1.551
    -0.85 ± 1.637
    -1.60 ± 1.673
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 [42]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
    Notes
    [42] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    65
    70
    49
    56
    118
    31
    62
    105
    129
    133
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    61.9 ± 16.18
    52.3 ± 18.09
    50.8 ± 17.82
    52.6 ± 19.43
    52.2 ± 18.94
    57.5 ± 21.39
    52.7 ± 18.38
    53.3 ± 17.21
    55.9 ± 20.51
    56.3 ± 16.21
        Change at Week 52
    18.5 ± 20.31
    27.0 ± 21.87
    27.9 ± 20.70
    30.8 ± 21.59
    23.5 ± 23.03
    22.9 ± 27.46
    25.0 ± 18.85
    19.9 ± 22.83
    20.8 ± 21.93
    17.6 ± 22.69
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 [43]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
    Notes
    [43] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Placebo)
    Number of subjects analysed
    29
    63
    45
    58
    106
    113
    120
    62
    54
    89
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.48 ± 1.379
    7.56 ± 1.267
    8.11 ± 1.434
    7.64 ± 1.385
    7.74 ± 1.545
    7.52 ± 1.464
    7.28 ± 1.348
    7.18 ± 1.337
    7.72 ± 1.420
    7.69 ± 1.489
        Change at Week 76
    -1.38 ± 1.498
    -1.33 ± 1.513
    -1.67 ± 1.430
    -1.52 ± 1.466
    -1.14 ± 1.496
    -1.05 ± 1.546
    -1.26 ± 1.481
    -1.05 ± 1.583
    -1.50 ± 1.724
    -1.11 ± 1.518
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 [44]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
    Notes
    [44] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Number of subjects analysed
    29
    63
    106
    113
    62
    54
    44
    57
    88
    119
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    58.8 ± 21.93
    52.0 ± 18.47
    51.4 ± 18.99
    55.8 ± 16.19
    62.3 ± 17.01
    52.0 ± 19.38
    50.7 ± 16.81
    52.4 ± 18.88
    52.5 ± 17.18
    56.1 ± 20.36
        Change at Week 76
    20.9 ± 25.66
    25.1 ± 19.62
    23.3 ± 21.40
    17.8 ± 22.04
    18.7 ± 20.65
    30.3 ± 23.68
    27.3 ± 18.87
    27.0 ± 21.49
    22.2 ± 20.82
    19.2 ± 25.10
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 [45]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
    Notes
    [45] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    45
    27
    58
    58
    49
    55
    84
    96
    114
    105
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    8.04 ± 1.507
    7.48 ± 1.451
    7.22 ± 1.325
    7.55 ± 1.391
    7.69 ± 1.446
    7.67 ± 1.375
    7.71 ± 1.428
    7.71 ± 1.507
    7.28 ± 1.360
    7.53 ± 1.401
        Change at Week 100
    -1.64 ± 1.773
    -1.48 ± 1.602
    -1.26 ± 1.528
    -1.43 ± 1.452
    -1.73 ± 1.741
    -1.62 ± 1.394
    -1.04 ± 1.609
    -1.16 ± 1.538
    -1.37 ± 1.477
    -0.98 ± 1.473
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 [46]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
    Notes
    [46] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    58
    49
    112
    54
    44
    82
    95
    103
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    59.2 ± 22.81
    61.3 ± 16.80
    52.9 ± 16.94
    53.8 ± 18.76
    56.5 ± 20.68
    51.9 ± 19.02
    50.7 ± 16.81
    51.9 ± 16.53
    52.2 ± 19.18
    55.3 ± 16.49
        Change at Week 100
    20.4 ± 27.47
    20.7 ± 17.45
    26.4 ± 21.82
    29.4 ± 23.09
    19.4 ± 26.78
    26.9 ± 21.76
    26.9 ± 22.39
    22.3 ± 20.11
    23.1 ± 21.82
    16.6 ± 21.92
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 [47]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
    Notes
    [47] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    54
    43
    47
    48
    80
    83
    97
    98
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.33 ± 1.271
    7.24 ± 1.329
    7.61 ± 1.406
    8.14 ± 1.457
    7.62 ± 1.423
    7.69 ± 1.446
    7.73 ± 1.441
    7.65 ± 1.510
    7.28 ± 1.223
    7.54 ± 1.401
        Change at Week 124
    -1.52 ± 1.805
    -1.07 ± 1.566
    -1.52 ± 1.539
    -1.70 ± 1.655
    -1.60 ± 1.690
    -1.69 ± 1.560
    -0.85 ± 1.662
    -1.05 ± 1.637
    -1.34 ± 1.560
    -1.07 ± 1.639
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 [48]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
    Notes
    [48] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    58
    54
    47
    82
    42
    47
    79
    96
    95
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    61.2 ± 21.60
    61.6 ± 16.98
    52.0 ± 16.58
    54.8 ± 17.87
    52.8 ± 19.62
    50.0 ± 16.87
    52.4 ± 19.58
    51.8 ± 16.77
    56.1 ± 20.59
    55.6 ± 15.81
        Change at Week 124
    24.0 ± 25.45
    19.7 ± 18.12
    23.8 ± 21.39
    28.1 ± 20.71
    23.8 ± 21.41
    29.4 ± 21.15
    24.5 ± 28.36
    21.1 ± 21.77
    22.2 ± 26.13
    18.1 ± 24.00
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 [49]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
    Notes
    [49] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    54
    53
    41
    43
    46
    76
    83
    94
    93
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.33 ± 1.271
    7.20 ± 1.337
    7.64 ± 1.415
    8.17 ± 1.447
    7.60 ± 1.450
    7.65 ± 1.370
    7.75 ± 1.434
    7.72 ± 1.541
    7.31 ± 1.376
    7.52 ± 1.396
        Change at Week 148
    -1.30 ± 1.589
    -1.26 ± 1.544
    -1.62 ± 1.417
    -1.66 ± 1.559
    -1.74 ± 1.774
    -1.67 ± 1.175
    -1.11 ± 1.740
    -1.36 ± 1.679
    -1.47 ± 1.591
    -1.24 ± 1.644
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 [50]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
    Notes
    [50] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    54
    53
    43
    83
    40
    45
    75
    92
    91
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    61.2 ± 21.60
    61.5 ± 17.24
    51.4 ± 16.62
    54.3 ± 18.04
    52.0 ± 19.73
    49.4 ± 17.04
    52.1 ± 19.63
    51.5 ± 16.66
    56.2 ± 20.93
    55.6 ± 16.31
        Change at Week 148
    23.4 ± 27.31
    21.9 ± 18.53
    28.7 ± 19.43
    28.2 ± 21.30
    24.6 ± 22.24
    28.2 ± 20.56
    24.7 ± 22.11
    24.9 ± 25.63
    23.9 ± 23.40
    21.1 ± 22.50
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 [51]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
    Notes
    [51] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13011 Placebo)
    Number of subjects analysed
    43
    53
    49
    43
    25
    75
    91
    81
    38
    70
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.65 ± 1.446
    7.17 ± 1.326
    7.67 ± 1.449
    7.70 ± 1.337
    7.28 ± 1.308
    7.81 ± 1.548
    7.33 ± 1.407
    7.62 ± 1.428
    8.03 ± 1.385
    7.71 ± 1.436
        Change at Week 172
    -1.74 ± 1.747
    -1.19 ± 1.665
    -1.45 ± 1.569
    -1.72 ± 1.098
    -1.24 ± 1.535
    -1.27 ± 1.695
    -1.52 ± 1.546
    -1.23 ± 1.653
    -1.76 ± 1.747
    -1.07 ± 1.722
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 [52]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
    Notes
    [52] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13008 De Novo Participants - CD) Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13008 De Novo Participants - UC)
    Number of subjects analysed
    43
    53
    80
    25
    75
    38
    70
    48
    42
    90
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    54.2 ± 17.79
    62.1 ± 16.84
    55.4 ± 15.90
    61.6 ± 22.40
    50.9 ± 19.40
    49.7 ± 17.87
    51.3 ± 16.58
    51.3 ± 16.87
    52.4 ± 20.42
    55.9 ± 20.95
        Change at Week 172
    29.4 ± 21.40
    20.3 ± 21.59
    22.2 ± 21.21
    19.8 ± 27.91
    23.9 ± 23.72
    29.2 ± 22.92
    26.0 ± 20.30
    25.9 ± 21.53
    25.9 ± 25.70
    25.2 ± 22.04
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 [53]
    End point description
    EQ-5D health states questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
    Notes
    [53] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    37
    50
    46
    41
    41
    66
    71
    62
    51
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    7.33 ± 1.271
    8.11 ± 1.487
    7.14 ± 1.325
    7.54 ± 1.312
    7.68 ± 1.474
    7.66 ± 1.389
    7.71 ± 1.476
    7.82 ± 1.579
    7.34 ± 1.292
    7.61 ± 1.297
        Change at Week 196
    -1.30 ± 1.436
    -1.89 ± 1.449
    -1.06 ± 1.490
    -1.52 ± 1.426
    -1.85 ± 1.783
    -1.90 ± 1.375
    -1.12 ± 1.687
    -1.42 ± 1.555
    -1.44 ± 1.656
    -1.37 ± 1.697
    No statistical analyses for this end point

    Primary: Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196

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    End point title
    Change from Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 [54]
    End point description
    EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
    End point type
    Primary
    End point timeframe
    Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
    Notes
    [54] - 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: Statistical analysis was not planned for this endpoint.
    End point values
    Vedolizumab 300 mg (C13006 Placebo) Vedolizumab 300 mg (C13007 Placebo) Vedolizumab 300 mg (C13006 Vedolizumab Q8W) Vedolizumab 300 mg (C13006 Vedolizumab Q4W) Vedolizumab 300 mg (C13007 Vedolizumab Q8W) Vedolizumab 300 mg (C13007 Vedolizumab Q4W) Vedolizumab 300 mg (C13011 Placebo) Vedolizumab 300 mg (C13011 Vedolizumab) Vedolizumab 300 mg (C13008 De Novo Participants - UC) Vedolizumab 300 mg (C13008 De Novo Participants - CD)
    Number of subjects analysed
    27
    37
    50
    46
    41
    41
    66
    71
    62
    51
    Units: score on a scale
    arithmetic mean (standard deviation)
        Baseline
    61.2 ± 21.60
    49.0 ± 18.41
    61.3 ± 16.63
    52.5 ± 17.01