Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis

    Summary
    EudraCT number
    		 2016-001392-78
    Trial protocol
    		 HU   GB   BE   SE   AT   PT   GR   SK   IS   ES   BG   DE   NL   HR   NO   IT  
    Global end of trial date
    31 Mar 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Apr 2021
    First version publication date
    08 Apr 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    GS-US-418-3898
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02914522
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, CA, United States, 94404
    Public contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com
    Scientific contact
    Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.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 Mar 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of filgotinib as compared with placebo in establishing endoscopy/bleeding/stool frequency (EBS) remission at Week 10 and Week 58.
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Norway: 6
    Country: Number of subjects enrolled
    Poland: 188
    Country: Number of subjects enrolled
    Portugal: 2
    Country: Number of subjects enrolled
    Slovakia: 4
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    Sweden: 6
    Country: Number of subjects enrolled
    United Kingdom: 40
    Country: Number of subjects enrolled
    Croatia: 6
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Belgium: 36
    Country: Number of subjects enrolled
    Bulgaria: 5
    Country: Number of subjects enrolled
    Czechia: 17
    Country: Number of subjects enrolled
    France: 80
    Country: Number of subjects enrolled
    Germany: 70
    Country: Number of subjects enrolled
    Greece: 5
    Country: Number of subjects enrolled
    Hungary: 28
    Country: Number of subjects enrolled
    Ireland: 2
    Country: Number of subjects enrolled
    United States: 181
    Country: Number of subjects enrolled
    India: 145
    Country: Number of subjects enrolled
    Japan: 109
    Country: Number of subjects enrolled
    Ukraine: 106
    Country: Number of subjects enrolled
    Russian Federation: 59
    Country: Number of subjects enrolled
    Italy: 57
    Country: Number of subjects enrolled
    Korea, Republic of: 33
    Country: Number of subjects enrolled
    Australia: 31
    Country: Number of subjects enrolled
    Romania: 19
    Country: Number of subjects enrolled
    Switzerland: 19
    Country: Number of subjects enrolled
    Canada: 17
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Israel: 11
    Country: Number of subjects enrolled
    New Zealand: 10
    Country: Number of subjects enrolled
    South Africa: 8
    Country: Number of subjects enrolled
    Georgia: 4
    Country: Number of subjects enrolled
    Hong Kong: 4
    Country: Number of subjects enrolled
    Serbia: 4
    Country: Number of subjects enrolled
    Argentina: 3
    Country: Number of subjects enrolled
    Malaysia: 3
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Singapore: 1
    Worldwide total number of subjects
    1351
    EEA total number of subjects
    550
    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)
    1262
    From 65 to 84 years
    89
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Australia, New Zealand, North America, South America, Asia and Europe. The first participant was screened on 14 November 2016. The last study visit occurred on 31 March 2020.

    Pre-assignment
    Screening details
    		 2040 participants were screened.

    Period 1
    Period 1 title
    Induction Study: Up to Week 11
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Induction Study (Cohort A): Filgotinib 200 mg
    Arm description
    		 Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily for 10 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Arm title
    		 Induction Study (Cohort A): Filgotinib 100 mg
    Arm description
    		 Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily for 10 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Arm title
    		 Induction Study (Cohort A): Placebo
    Arm description
    		 Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Arm title
    		 Induction Study (Cohort B): Filgotinib 200 mg
    Arm description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily for 10 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Arm title
    		 Induction Study (Cohort B): Filgotinib 100 mg
    Arm description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily for 10 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Arm title
    		 Induction Study (Cohort B): Placebo
    Arm description
    		 Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily for 10 weeks

    Number of subjects in period 1 [1]
    		Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Started
    245
    277
    137
    262
    285
    142
    Completed
    235
    256
    127
    234
    262
    127
    Not completed
    10
    21
    10
    28
    23
    15
         Protocol violation
    -
    2
    1
    3
    4
    2
         Pregnancy
    -
    -
    -
    -
    1
    -
         Adverse event
    5
    6
    4
    18
    14
    10
         Non-compliance with study drug
    1
    -
    -
    -
    -
    -
         Withdrew consent
    4
    11
    4
    6
    3
    3
         Lost to follow-up
    -
    2
    1
    1
    -
    -
         Investigator's discretion
    -
    -
    -
    -
    1
    -
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 3 participants who were randomized but not treated were not included in the Safety Analysis Set.
    Period 2
    Period 2 title
    Maintenance Study: Week 11 to Week 58
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg
    Arm description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg administered once daily up to 47 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily up to 47 weeks

    Arm title
    		 Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Arm description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily up to 47 weeks

    Arm title
    		 Maintenance Study: FIL 100 mg From Induction FIL 100 mg
    Arm description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Filgotinib
    Investigational medicinal product code
    Other name
    GS-6034, formerly GLPG0634
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg administered once daily up to 47 weeks

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily up to 47 weeks

    Arm title
    		 Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Arm description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily up to 47 weeks

    Arm title
    		 Maintenance Study: Placebo From Induction Placebo
    Arm description
    		 Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily once daily for an additional 47 weeks (up to Week 58).
    Arm type
    		 Placebo

    Investigational medicinal product name
    PTM filgotinib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo administered once daily up to 47 weeks

    Number of subjects in period 2 [2]
    		Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Started
    202
    99
    179
    91
    93
    Completed
    150
    41
    104
    42
    64
    Not completed
    52
    58
    75
    49
    29
         Protocol-specified disease worsening
    34
    49
    53
    39
    21
         Protocol violation
    5
    5
    3
    -
    1
         Death
    2
    -
    -
    -
    -
         Pregnancy
    -
    -
    1
    2
    -
         Adverse event
    7
    2
    10
    4
    3
         Non-compliance with study drug
    -
    -
    -
    1
    -
         Withdrew consent
    4
    1
    6
    3
    4
         Investigator's discretion
    -
    1
    2
    -
    -
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants achieved either EBS remission/MCS response at Week 10 continued into Maintenance Study.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Induction Study (Cohort A): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Placebo
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Placebo
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks

    Reporting group values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Total
    Number of subjects
    		 245 277 137 262 285 142 1348
    Age categorical
    Units: Subjects
        <=18 years
    		 0 0 0 0 0 0 0
        Between 18 and 65 years
    		 234 261 129 243 264 128 1259
        >=65 years
    		 11 16 8 19 21 14 89
    Gender categorical
    Units: Subjects
        Female
    		 122 120 50 114 99 56 561
        Male
    		 123 157 87 148 186 86 787
    Race
    Not Permitted = local regulators did not allow collection of race or ethnicity information.
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 0 0 1
        Asian
    		 77 79 38 50 51 27 322
        Black or African American
    		 2 3 1 4 6 3 19
        White
    		 165 192 95 190 212 98 952
        Other
    		 0 2 2 0 0 1 5
        Not Permitted
    		 0 1 1 18 16 13 49
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 238 269 134 249 273 134 1297
        Hispanic or Latino
    		 6 6 3 8 8 4 35
        Not Permitted
    		 1 2 0 5 4 4 16

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Induction Study (Cohort A): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Placebo
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Placebo
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks
    Reporting group title
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg
    Reporting group description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Reporting group description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg
    Reporting group description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Reporting group description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Placebo
    Reporting group description
    		 Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily once daily for an additional 47 weeks (up to Week 58).

    Subject analysis set title
    Induction Study (Cohort A): Filgotinib 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Subject analysis set title
    Induction Study (Cohort A): Filgotinib 100 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Subject analysis set title
    Induction Study (Cohort A): Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Subject analysis set title
    Induction Study (Cohort B): Filgotinib 200 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Subject analysis set title
    Induction Study (Cohort B): Filgotinib 100 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Subject analysis set title
    Induction Study (Cohort B): Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Primary: Induction Study: Percentage of Participants Who Achieved EBS Remission at Week 10

    		 Close Top of page
    End point title
    		 Induction Study: Percentage of Participants Who Achieved EBS Remission at Week 10
    End point description
    EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease. Full Analysis Set (FAS) for the Induction study (Cohorts A and B) included all randomised participants who took at least 1 dose of study drug in the corresponding Induction study.
    End point type
    Primary
    End point timeframe
    Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Number of subjects analysed
    245
    277
    137
    262
    285
    142
    Units: percentage of participants
        number (confidence interval 95%)
    26.1 (20.4 to 31.8)
    19.1 (14.3 to 23.9)
    15.3 (8.9 to 21.7)
    11.5 (7.4 to 15.5)
    9.5 (5.9 to 13.0)
    4.2 (0.6 to 7.9)
    Statistical analysis title
    		 Induction Study (Cohort A): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 200 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0157 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    10.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.1
         upper limit
    		 19.5
    Notes
    [1] - Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort A): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 100 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3379 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    3.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.3
         upper limit
    		 12
    Notes
    [2] - CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort B): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 200 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0103 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    7.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 12.8
    Notes
    [3] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).
    Statistical analysis title
    		 Induction Study (Cohort B): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 100 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0645 [4]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 10.5
    Notes
    [4] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).

    Primary: Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
    End point description
    EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease. Full Analysis Set for the Maintenance Study included all participants randomised to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Study (Cohorts A and B) who achieved EBS remission or MCS response at Week 10, were rerandomised, and took at least 1 dose of study drug in the Maintenance Study.
    End point type
    Primary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    37.2 (30.2 to 44.2)
    11.2 (4.5 to 18.0)
    23.8 (17.2 to 30.5)
    13.5 (5.8 to 21.1)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16
         upper limit
    		 35.9
    Notes
    [5] - CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at maintenance baseline, and participation in Induction Study (Cohort A or B).
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.042 [6]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    10.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 20.7
    Notes
    [6] - CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at maintenance baseline, and participation in Induction Study (Cohort A or B).

    Secondary: Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10

    		 Close Top of page
    End point title
    		 Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
    End point description
    MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analysed.
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Number of subjects analysed
    245
    277
    137
    262
    285
    142
    Units: percentage of participants
        number (confidence interval 95%)
    24.5 (18.9 to 30.1)
    17.0 (12.4 to 21.6)
    12.4 (6.5 to 18.3)
    9.5 (5.8 to 13.3)
    6.0 (3.0 to 8.9)
    4.2 (0.6 to 7.9)
    Statistical analysis title
    		 Induction Study (Cohort A): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 200 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0053 [7]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 20.4
    Notes
    [7] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort A): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 100 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2295 [8]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 12.2
    Notes
    [8] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort B): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 200 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0393 [9]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    5.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 10.7
    Notes
    [9] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).
    Statistical analysis title
    		 Induction Study (Cohort B): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 100 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5308 [10]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.1
         upper limit
    		 6.6
    Notes
    [10] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).

    Secondary: Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10

    		 Close Top of page
    End point title
    		 Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
    End point description
    Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analysed.
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Number of subjects analysed
    245
    277
    137
    262
    285
    142
    Units: percentage of participants
        number (confidence interval 95%)
    12.2 (7.9 to 16.6)
    5.8 (2.8 to 8.7)
    3.6 (0.1 to 7.2)
    3.4 (1.0 to 5.8)
    2.1 (0.3 to 3.9)
    2.1 (0.0 to 4.8)
    Statistical analysis title
    		 Induction Study (Cohort A): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 200 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0047 [11]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    8.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.9
         upper limit
    		 14.3
    Notes
    [11] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort A): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 100 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3495 [12]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    2.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.6
         upper limit
    		 6.8
    Notes
    [12] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort B): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 200 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4269 [13]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 5.1
    Notes
    [13] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).
    Statistical analysis title
    		 Induction Study (Cohort B): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 100 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9987 [14]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 3.4
    Notes
    [14] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).

    Secondary: Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10

    		 Close Top of page
    End point title
    		 Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
    End point description
    Geboes histologic remission assessed using Geboes histologic scores for evaluation of disease severity in UC and classifies histologic changes. Remission:Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1:Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0=No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Participants in FAS for Induction study (Cohorts A and B) were analysed.
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Number of subjects analysed
    245
    277
    137
    262
    285
    142
    Units: percentage of participants
        number (confidence interval 95%)
    35.1 (28.9 to 41.3)
    23.8 (18.6 to 29.0)
    16.1 (9.5 to 22.6)
    19.8 (14.8 to 24.9)
    13.7 (9.5 to 17.8)
    8.5 (3.5 to 13.4)
    Statistical analysis title
    		 Induction Study (Cohort A): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 200 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [15]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 9.9
         upper limit
    		 28.2
    Notes
    [15] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort A): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 100 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0672 [16]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    7.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.7
         upper limit
    		 16.2
    Notes
    [16] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort B): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 200 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0019 [17]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    11.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 4.2
         upper limit
    		 18.6
    Notes
    [17] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).
    Statistical analysis title
    		 Induction Study (Cohort B): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 100 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1286 [18]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    5.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 11.8
    Notes
    [18] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).

    Secondary: Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10

    		 Close Top of page
    End point title
    		 Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
    End point description
    MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Participants in the Full Analysis Set for the Induction Study (Cohorts A and B) were analysed.
    End point type
    Secondary
    End point timeframe
    Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo
    Number of subjects analysed
    245
    277
    137
    262
    285
    142
    Units: percentage of participants
        number (confidence interval 95%)
    12.2 (7.9 to 16.6)
    8.7 (5.2 to 12.2)
    4.4 (0.6 to 8.2)
    3.8 (1.3 to 6.3)
    2.1 (0.3 to 3.9)
    2.1 (0.0 to 4.8)
    Statistical analysis title
    		 Induction Study (Cohort A): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 200 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    382
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0105 [19]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    7.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.9
         upper limit
    		 13.8
    Notes
    [19] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort A): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort A): Filgotinib 100 mg v Induction Study (Cohort A): Placebo
    Number of subjects included in analysis
    414
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1062 [20]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1
         upper limit
    		 9.6
    Notes
    [20] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1.
    Statistical analysis title
    		 Induction Study (Cohort B): 200 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 200 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    404
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3084 [21]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.2
         upper limit
    		 5.6
    Notes
    [21] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).
    Statistical analysis title
    		 Induction Study (Cohort B): 100 mg vs Placebo
    Comparison groups
    Induction Study (Cohort B): Filgotinib 100 mg v Induction Study (Cohort B): Placebo
    Number of subjects included in analysis
    427
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9109 [22]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 3.4
    Notes
    [22] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Day 1, and number of prior exposure to biologic agent (<=1, >1).

    Secondary: Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845

    		 Close Top of page
    End point title
    		 Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
    End point description
    Cmax is defined as the maximum observed concentration of drug. PK Substudy Analysis Set included all randomised participants who took at least 1 dose of filgotinib, participated in the PK substudy, and had at least 1 nonmissing intensive concentration value for filgotinib and/or GS-829845 with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Number of subjects analysed
    4
    11
    9
    17
    Units: nanograms per millilitre (ng/mL)
    arithmetic mean (standard deviation)
        Filgotinib (n= 4, 10, 9 ,17)
    1746.3 ( 1244.05 )
    725.1 ( 313.36 )
    2283.3 ( 1012.03 )
    977.9 ( 403.51 )
        Metabolite GS-829845 (n= 4, 11, 9, 17)
    3227.5 ( 1204.50 )
    1812.2 ( 701.46 )
    4373.3 ( 1121.58 )
    2002.9 ( 598.73 )
    No statistical analyses for this end point

    Secondary: Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845

    		 Close Top of page
    End point title
    		 Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
    End point description
    Tmax is defined as the time to reach maximum observed concentration of drug. Participants in the PK Substudy Analysis Set with available data were analysed.
    End point type
    Secondary
    End point timeframe
    Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Number of subjects analysed
    4
    11
    9
    17
    Units: hour (h)
    median (full range (min-max))
        Filgotinib (n= 4, 10, 9 ,17)
    1.50 (0.75 to 2.00)
    0.75 (0.50 to 3.00)
    1.00 (0.50 to 2.25)
    0.57 (0.42 to 3.00)
        Metabolite GS-829845 (n= 4, 11, 9, 17)
    3.76 (2.00 to 4.00)
    3.00 (1.00 to 6.00)
    3.02 (2.13 to 6.00)
    3.00 (1.03 to 6.00)
    No statistical analyses for this end point

    Secondary: Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984

    		 Close Top of page
    End point title
    		 Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
    End point description
    AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). Participants in the PK Substudy Analysis Set with available data were analysed.
    End point type
    Secondary
    End point timeframe
    Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Number of subjects analysed
    4
    11
    9
    17
    Units: hour*nanograms per millilitre (h*ng/mL)
    arithmetic mean (standard deviation)
        Filgotinib (n= 4, 10, 8 ,15)
    5501.3 ( 1956.39 )
    1909.3 ( 788.13 )
    6475.6 ( 1643.00 )
    2492.3 ( 852.52 )
        Metabolite GS-829845 (n= 4, 10, 7, 15)
    57982.0 ( 17767.52 )
    31187.9 ( 11858.78 )
    80208.6 ( 25096.57 )
    36075.6 ( 13396.86 )
    No statistical analyses for this end point

    Secondary: Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984

    		 Close Top of page
    End point title
    		 Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
    End point description
    AUClast is defined as the concentration of drug from time zero to the last observable concentration. Participants in the PK Substudy Analysis Set with available data were analysed.
    End point type
    Secondary
    End point timeframe
    Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Number of subjects analysed
    4
    11
    9
    17
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Filgotinib (n= 4, 10, 9 ,17)
    5537.3 ( 1900.93 )
    1881.9 ( 797.51 )
    6743.1 ( 1743.68 )
    2420.3 ( 837.26 )
        Metabolite GS-829845 (n= 4, 11, 9, 17)
    60938.4 ( 6961.77 )
    30643.2 ( 12935.37 )
    79286.3 ( 27968.49 )
    34385.6 ( 15160.15 )
    No statistical analyses for this end point

    Secondary: Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984

    		 Close Top of page
    End point title
    		 Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the PK Substudy Analysis Set with available data were analysed.
    End point type
    Secondary
    End point timeframe
    Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 8
    End point values
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg
    Number of subjects analysed
    4
    11
    9
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Filgotinib (n= 3, 8, 8 ,13)
    12.0 ( 4.74 )
    4.5 ( 3.61 )
    36.6 ( 79.06 )
    4.1 ( 3.05 )
        Metabolite GS-829845 (n= 3, 10, 8, 15)
    2050.0 ( 493.66 )
    934.8 ( 372.68 )
    2581.3 ( 777.07 )
    1062.8 ( 463.67 )
    No statistical analyses for this end point

    Secondary: Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
    End point description
    MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Participants in the Full Analysis Set for the Maintenance Study were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    34.7 (27.8 to 41.5)
    9.2 (3.0 to 15.4)
    22.7 (16.1 to 29.2)
    13.5 (5.8 to 21.1)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [23]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    25.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16
         upper limit
    		 35
    Notes
    [23] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0658 [24]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.1
         upper limit
    		 19.5
    Notes
    [24] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.

    Secondary: Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
    End point description
    Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58. Participants in the Full Analysis Set for the Maintenance Study were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    18.1 (12.5 to 23.7)
    5.1 (0.2 to 10.0)
    8.7 (4.2 to 13.2)
    7.9 (1.7 to 14.0)
    Statistical analysis title
    		 Maintenance Study: Filgotinib 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0024 [25]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.3
         upper limit
    		 20.6
    Notes
    [25] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7951 [26]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7
         upper limit
    		 8.7
    Notes
    [26] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.

    Secondary: Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
    End point description
    Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58. Participants in the Full Analysis Set who were on corticosteroids at Maintenance Study baseline were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    92
    47
    81
    37
    Units: percentage of participants
        number (confidence interval 95%)
    27.2 (17.5 to 36.8)
    6.4 (0.0 to 14.4)
    13.6 (5.5 to 21.7)
    5.4 (0.0 to 14.0)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    139
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0055 [27]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    20.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.7
         upper limit
    		 33.9
    Notes
    [27] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    118
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1265 [28]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    8.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.2
         upper limit
    		 20.6
    Notes
    [28] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.

    Secondary: Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
    End point description
    Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). Participants in the Full Analysis Set for the Maintenance Study were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    15.6 (10.3 to 20.9)
    6.1 (0.9 to 11.4)
    13.4 (8.0 to 18.7)
    7.9 (1.7 to 14.0)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0157 [29]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    9.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.8
         upper limit
    		 17.1
    Notes
    [29] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1808 [30]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    5.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 13.9
    Notes
    [30] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.

    Secondary: Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
    End point description
    Geboes histologic remission assessed using Geboes histologic scores for evaluation of disease severity in UC and classifies histologic changes. Remission:Grade 0 of <=0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1:Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0=No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue). Participants in Full Analysis Set for the Maintenance Study were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    38.2 (31.2 to 45.2)
    13.3 (6.0 to 20.5)
    27.9 (20.9 to 34.9)
    18.0 (9.4 to 26.5)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [31]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    24.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.6
         upper limit
    		 35.2
    Notes
    [31] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0521 [32]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    9.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 21.2
    Notes
    [32] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.

    Secondary: Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58

    		 Close Top of page
    End point title
    		 Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
    End point description
    MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA assessment subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]). Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease. Participants in the Full Analysis Set for the Maintenance Study were analysed.
    End point type
    Secondary
    End point timeframe
    Week 58
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects analysed
    199
    98
    172
    89
    Units: percentage of participants
        number (confidence interval 95%)
    22.1 (16.1 to 28.1)
    6.1 (0.9 to 11.4)
    12.2 (7.0 to 17.4)
    7.9 (1.7 to 14.0)
    Statistical analysis title
    		 Maintenance Study: 200 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg v Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0005 [33]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 7.8
         upper limit
    		 24.2
    Notes
    [33] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participation in Cohort A or B.
    Statistical analysis title
    		 Maintenance Study: 100 mg vs Placebo
    Comparison groups
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg v Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Number of subjects included in analysis
    261
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.2946 [34]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Difference in Percentages
    Point estimate
    4.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.9
         upper limit
    		 12.6
    Notes
    [34] - CMH test is stratified by concomitant use of oral, systemic corticosteroids (Yes or No) and of immunomodulators (Yes or No) at Maintenance baseline, and participating in Cohort A or B.

    Secondary: Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845

    		 Close Top of page
    End point title
    		 Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
    End point description
    Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845. PK Analysis Set included all participants in the Safety Analysis Set who who took at least 1 dose of filgotinib and had at least 1 nonmissing plasma concentration value for filgotinib and/or its metabolite GS-829845 with available data were analysed. -99999 signifies the value was below the limit of quantitation. Data was not collected for the Maintenance Study Placebo arms.
    End point type
    Secondary
    End point timeframe
    Week 26 (any Time) and Week 58 (predose)
    End point values
    		 Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg
    Number of subjects analysed
    173
    136
    Units: ng/mL
    median (inter-quartile range (Q1-Q3))
        Filgotinib: Week 26 (n= 169, 127)
    8.5 (5.0 to 25.8)
    4.4 (2.5 to 14.0)
        Filgotinib: Week 58 (n= 44, 26)
    3.9 (-99999 to 9.1)
    4.1 (-99999 to 6.9)
        Metabolite GS-829845: Week 26 (n= 170, 130)
    2495.0 (1940.0 to 3010.0)
    1180.0 (852.0 to 1550.0)
        Metabolite GS-829845: Week 58 (n= 44, 26)
    1930.0 (1320.0 to 2630.0)
    973.5 (773.0 to 1350.0)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Induction Study: first dose date up to one day before the Maintenance first dose date or last dose date whichever is earlier (maximum 17 weeks) plus 30 days, Maintenance study: First dose to the last dose in the Maintenance Study (maximum 51 weeks) plus
    Adverse event reporting additional description
    Adverse Events: Safety Analysis Set for the study included all participants who took at least 1 dose of study drug in either the Induction Study (Cohorts A and B) or the Maintenance Study. All-Cause Mortality: All Randomized Analysis Set included all participants who were randomized on Day 1 into each corresponding study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Induction Study (Cohort A): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort A): Placebo
    Reporting group description
    		 Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 200 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Induction Study (Cohort B): Filgotinib 100 mg
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks

    Reporting group title
    Induction Study (Cohort B): Placebo
    Reporting group description
    		 Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.

    Reporting group title
    Maintenance Study: FIL 200 mg From Induction FIL 200 mg
    Reporting group description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Filgotinib 200 mg
    Reporting group description
    		 Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: FIL 100 mg From Induction FIL 100 mg
    Reporting group description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Filgotinib 100 mg
    Reporting group description
    		 Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Reporting group title
    Maintenance Study: Placebo From Induction Placebo
    Reporting group description
    		 Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).

    Serious adverse events
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 245 (1.22%)
    13 / 277 (4.69%)
    4 / 137 (2.92%)
    19 / 262 (7.25%)
    15 / 285 (5.26%)
    9 / 142 (6.34%)
    9 / 202 (4.46%)
    0 / 99 (0.00%)
    8 / 179 (4.47%)
    7 / 91 (7.69%)
    4 / 93 (4.30%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic infarction
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Type I hypersensitivity
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst ruptured
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femur fracture
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    1 / 137 (0.73%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery stenosis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 245 (0.41%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    1 / 137 (0.73%)
    1 / 262 (0.38%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    0 / 245 (0.00%)
    3 / 277 (1.08%)
    3 / 137 (2.19%)
    7 / 262 (2.67%)
    5 / 285 (1.75%)
    5 / 142 (3.52%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 4
    1 / 7
    0 / 5
    0 / 5
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal mucocoele
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dental cyst
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 245 (0.41%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supernumerary teeth
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    2 / 262 (0.76%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    2 / 179 (1.12%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    1 / 137 (0.73%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    2 / 285 (0.70%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute hepatitis B
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    1 / 142 (0.70%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    1 / 262 (0.38%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 245 (0.41%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    1 / 202 (0.50%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 245 (0.00%)
    1 / 277 (0.36%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    1 / 137 (0.73%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    1 / 179 (0.56%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    0 / 285 (0.00%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    1 / 93 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 245 (0.00%)
    0 / 277 (0.00%)
    0 / 137 (0.00%)
    0 / 262 (0.00%)
    1 / 285 (0.35%)
    0 / 142 (0.00%)
    0 / 202 (0.00%)
    0 / 99 (0.00%)
    0 / 179 (0.00%)
    0 / 91 (0.00%)
    0 / 93 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Induction Study (Cohort A): Filgotinib 200 mg Induction Study (Cohort A): Filgotinib 100 mg Induction Study (Cohort A): Placebo Induction Study (Cohort B): Filgotinib 200 mg Induction Study (Cohort B): Filgotinib 100 mg Induction Study (Cohort B): Placebo Maintenance Study: FIL 200 mg From Induction FIL 200 mg Maintenance Study: Placebo From Induction Filgotinib 200 mg Maintenance Study: FIL 100 mg From Induction FIL 100 mg Maintenance Study: Placebo From Induction Filgotinib 100 mg Maintenance Study: Placebo From Induction Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 245 (16.33%)
    43 / 277 (15.52%)
    20 / 137 (14.60%)
    83 / 262 (31.68%)
    77 / 285 (27.02%)
    55 / 142 (38.73%)
    67 / 202 (33.17%)
    33 / 99 (33.33%)
    53 / 179 (29.61%)
    33 / 91 (36.26%)
    26 / 93 (27.96%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 245 (4.49%)
    12 / 277 (4.33%)
    6 / 137 (4.38%)
    19 / 262 (7.25%)
    10 / 285 (3.51%)
    9 / 142 (6.34%)
    7 / 202 (3.47%)
    0 / 99 (0.00%)
    10 / 179 (5.59%)
    5 / 91 (5.49%)
    5 / 93 (5.38%)
         occurrences all number
    11
    14
    8
    21
    13
    13
    8
    0
    10
    5
    8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 245 (2.45%)
    10 / 277 (3.61%)
    4 / 137 (2.92%)
    12 / 262 (4.58%)
    11 / 285 (3.86%)
    10 / 142 (7.04%)
    4 / 202 (1.98%)
    0 / 99 (0.00%)
    4 / 179 (2.23%)
    1 / 91 (1.10%)
    0 / 93 (0.00%)
         occurrences all number
    7
    10
    4
    12
    11
    11
    4
    0
    4
    1
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    5 / 245 (2.04%)
    1 / 277 (0.36%)
    1 / 137 (0.73%)
    6 / 262 (2.29%)
    3 / 285 (1.05%)
    8 / 142 (5.63%)
    6 / 202 (2.97%)
    1 / 99 (1.01%)
    4 / 179 (2.23%)
    3 / 91 (3.30%)
    1 / 93 (1.08%)
         occurrences all number
    5
    1
    1
    6
    4
    8
    7
    1
    4
    3
    1
    Gastrointestinal disorders
    Colitis ulcerative
         subjects affected / exposed
    6 / 245 (2.45%)
    3 / 277 (1.08%)
    5 / 137 (3.65%)
    14 / 262 (5.34%)
    11 / 285 (3.86%)
    6 / 142 (4.23%)
    21 / 202 (10.40%)
    18 / 99 (18.18%)
    18 / 179 (10.06%)
    16 / 91 (17.58%)
    10 / 93 (10.75%)
         occurrences all number
    6
    3
    5
    14
    11
    6
    23
    18
    18
    17
    11
    Abdominal pain
         subjects affected / exposed
    3 / 245 (1.22%)
    3 / 277 (1.08%)
    3 / 137 (2.19%)
    8 / 262 (3.05%)
    7 / 285 (2.46%)
    9 / 142 (6.34%)
    8 / 202 (3.96%)
    6 / 99 (6.06%)
    6 / 179 (3.35%)
    2 / 91 (2.20%)
    4 / 93 (4.30%)
         occurrences all number
    3
    3
    3
    9
    7
    9
    8
    9
    7
    2
    4
    Nausea
         subjects affected / exposed
    8 / 245 (3.27%)
    3 / 277 (1.08%)
    1 / 137 (0.73%)
    7 / 262 (2.67%)
    15 / 285 (5.26%)
    6 / 142 (4.23%)
    5 / 202 (2.48%)
    1 / 99 (1.01%)
    4 / 179 (2.23%)
    0 / 91 (0.00%)
    2 / 93 (2.15%)
         occurrences all number
    8
    3
    1
    8
    16
    6
    6
    1
    4
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 245 (0.00%)
    4 / 277 (1.44%)
    2 / 137 (1.46%)
    8 / 262 (3.05%)
    10 / 285 (3.51%)
    7 / 142 (4.93%)
    8 / 202 (3.96%)
    7 / 99 (7.07%)
    6 / 179 (3.35%)
    3 / 91 (3.30%)
    4 / 93 (4.30%)
         occurrences all number
    0
    5
    2
    8
    11
    8
    9
    7
    6
    3
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 245 (2.86%)
    9 / 277 (3.25%)
    2 / 137 (1.46%)
    20 / 262 (7.63%)
    20 / 285 (7.02%)
    11 / 142 (7.75%)
    22 / 202 (10.89%)
    6 / 99 (6.06%)
    12 / 179 (6.70%)
    6 / 91 (6.59%)
    5 / 93 (5.38%)
         occurrences all number
    7
    9
    2
    21
    21
    11
    25
    8
    17
    6
    5
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 245 (0.82%)
    2 / 277 (0.72%)
    0 / 137 (0.00%)
    13 / 262 (4.96%)
    4 / 285 (1.40%)
    5 / 142 (3.52%)
    11 / 202 (5.45%)
    3 / 99 (3.03%)
    6 / 179 (3.35%)
    3 / 91 (3.30%)
    3 / 93 (3.23%)
         occurrences all number
    3
    2
    0
    14
    4
    6
    12
    4
    8
    3
    3

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 Sep 2016
    Amendment 1: • Updates were made in the text in response to US Food and Drug Administration (FDA) requests. • Updated Study Procedures Table and footnotes to reflect changes made to study visits assessments/procedures in the protocol. • Protocol GS-US-418-3899 title changed from open-label extension to long-term extension (LTE) study. • Sections were updated with emerging relevant nonclinical and clinical data. • A novel histologic endpoint was added to account for the evolution of understanding and thinking surrounding histologic healing. • Criteria for discontinuation for febrile neutropenia, anemia, and international normalized ratio (INR) value when considering hepatic laboratory changes were added to ensure subject safety. Additional text surrounding departure from the study clarified that pregnant subjects were to discontinue the study and that early termination (ET) and posttreatment visits were requested for subjects withdrawing. • An exclusion criterion of severe hepatic impairment defined by Child-Pugh Class C was added.
    27 Oct 2016
    Amendment 2: • Updates were made in the text in response to the Voluntary Harmonization Procedure (VHP) request to include MCS remission (alternative definition) as a secondary endpoint at Week 10 and Week 58. • Text was updated to clarify that lymphocyte-depleting therapies and natalizumab were prohibited concomitant medications for the duration of the study. • A rationale for the exclusion of potent P-glycoprotein (P-gp) inducers was added upon VHP request. • Additional Week 26 and Week 58 electrocardiogram (ECG) procedures were added upon VHP request. • Text was added to clarify that coagulation parameters should be tested in cases where either aspartate or alanine aminotransferase (AST/ALT) was > 3 * upper limit of normal (ULN), to enable compliance with subject discontinuation parameters based on AST/ALT and INR.
    15 Jun 2017
    Amendment 3: • Updates were made in the text in response to the South Korean Ministry of Food and Drug Safety request that the use of filgotinib 200 mg in males in Korea be limited to subjects who had failed 2 classes of biologic therapies (any TNF-α antagonist and vedolizumab). • Guidance from investigators regarding rate of steroid tapering was added to text and clarity was added regarding handling of subjects who exceed baseline steroid doses. • Sections were updated with emerging relevant clinical and pipeline data. • Text was updated to reflect that subjects were up to date on colorectal cancer surveillance processes prior to entering the screening period. • Text was added to clarify the type of colectomies that were excluded • Clarity around tuberculosis (TB) eligibility was added. • Instructions for recording the Normal Stool Count and ensuring eligibility prior to endoscopy were added.
    05 Mar 2018
    Amendment 4: • The number of sites was increased to ensure that a target number of subjects were enrolled in the study considering the accumulated enrollment rate. • Provided additional clarity on inclusion/exclusion criteria including those for hepatitis. • Provided additional flexibility for enhanced safety monitoring (with increased flexibility for data monitoring committee [DMC] meeting scheduling and suggested infectious workups for disease worsening).
    02 Apr 2019
    Amendment 5: • Removed plans for interim unblinded analysis for a prespecified sponsor’s executive team review.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 20:14:28 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA