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    Clinical Trial Results:
    A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2)

    Summary
    EudraCT number
    		 2017-003238-96
    Trial protocol
    		 DE   GB   NL   LV   CZ   LT   ES   BE   HU   AT   SK   DK   HR   IT   RO  
    Global end of trial date
    17 Feb 2025

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Mar 2026
    First version publication date
    15 Dec 2022
    Other versions
    		 v1
    Version creation reason
    • New data added to full data set
    Final results to be added with ME2 Data

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I6T-MC-AMBG
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03524092
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16823
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    Lilly Corporate Center, Indianapolis, IN, United States, 46285
    Public contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,
    Scientific contact
    Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,
    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
    17 Feb 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Nov 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Oct 2018
    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
    Argentina: 11
    Country: Number of subjects enrolled
    Australia: 12
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Canada: 31
    Country: Number of subjects enrolled
    China: 166
    Country: Number of subjects enrolled
    Czechia: 52
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    France: 57
    Country: Number of subjects enrolled
    Germany: 37
    Country: Number of subjects enrolled
    Hungary: 23
    Country: Number of subjects enrolled
    India: 72
    Country: Number of subjects enrolled
    Ireland: 1
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Italy: 36
    Country: Number of subjects enrolled
    Japan: 123
    Country: Number of subjects enrolled
    Latvia: 29
    Country: Number of subjects enrolled
    Lithuania: 22
    Country: Number of subjects enrolled
    Malaysia: 6
    Country: Number of subjects enrolled
    Mexico: 10
    Country: Number of subjects enrolled
    Netherlands: 10
    Country: Number of subjects enrolled
    Poland: 122
    Country: Number of subjects enrolled
    Romania: 14
    Country: Number of subjects enrolled
    Russian Federation: 100
    Country: Number of subjects enrolled
    Serbia: 21
    Country: Number of subjects enrolled
    Slovakia: 21
    Country: Number of subjects enrolled
    Korea, Republic of: 25
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    Switzerland: 10
    Country: Number of subjects enrolled
    Taiwan: 3
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    Ukraine: 93
    Country: Number of subjects enrolled
    United Kingdom: 14
    Country: Number of subjects enrolled
    United States: 140
    Worldwide total number of subjects
    1328
    EEA total number of subjects
    468
    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)
    1216
    From 65 to 84 years
    112
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 1177 Participants (pts) enrolled in study of which 716 participants entered Blinded Maintenance Period as Induction Responder (IR) and 461 pts entered into open label extended Induction period as Induction Nonresponders. China Maximized Extended Enrollment (ME2): This is an extension phase of the main study, with an additional 151 pts.

    Pre-assignment
    Screening details
    		 This study designed to evaluate safety and efficacy of mirikizumab (miri) in achieving remission at Week (Wk) 40 in pts who completed 12 wk induction study I6T-MC-AMAN(NCT03518086) as clinical responders to mirikizumab. As pre-specified in analysis plan,outcome measures were not reported for ME2 arms/groups, as no formal efficacy was pre-specified

    Period 1
    Period 1 title
    Blinded Maintenance Period (Wk 0-40)
    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
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC)
    Arm description
    		 Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PBO SC every 4 weeks (Q4W).

    Arm title
    		 Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Arm description
    		 Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab SC Q4W.

    Arm title
    		 Maintenance Period: PBO IR - PBO SC
    Arm description
    		 Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
    Arm type
    		 PBO IR

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PBO SC every 4 weeks (Q4W).

    Arm title
    		 Maintenance Period: Miri IR - PBO SC - ME2 Cohort
    Arm description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PBO SC Q4W (ME2 Cohort).

    Arm title
    		 Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Arm description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab SC Q4W (ME2 Cohort).

    Arm title
    		 Maintenance Period: PBO IR - PBO SC - ME2 Cohort
    Arm description
    		 Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PBO SC every Q4W (ME2 Cohort).

    Number of subjects in period 1 [1]
    		Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC Maintenance Period: PBO IR - PBO SC Maintenance Period: Miri IR - PBO SC - ME2 Cohort Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort Maintenance Period: PBO IR - PBO SC - ME2 Cohort
    Started
    192
    389
    135
    21
    52
    12
    Received at Least One Dose of Study Drug
    192
    389
    135
    21
    52
    12
    Completed
    119
    347
    90
    12
    46
    8
    Not completed
    73
    42
    45
    9
    6
    4
         Consent withdrawn by subject
    7
    8
    6
    1
    -
    -
         Physician decision
    -
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    16
    6
    1
    2
    4
    -
         Pregnancy
    -
    -
    1
    -
    -
    -
         Protocol Violation
    -
    1
    1
    -
    -
    -
         Loss of Response Rescue Period
    42
    19
    29
    6
    2
    4
         Lost to follow-up
    -
    1
    -
    -
    -
    -
         Lack of efficacy
    8
    6
    7
    -
    -
    -
    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: Data is reported separately for Blinded Maintenance Period as Induction Responder (IR) and open label extended Induction period as Induction Nonresponders.
    Period 2
    Period 2 title
    Open Label Extended Induction (Wk 0-12)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Extended Induction: Induction Nonresponders - 300mg Miri IV
    Arm description
    		 Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
    Arm type
    		 Induction Nonresponders

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg mirikizumab IV Q4W for 3 doses.

    Arm title
    		 Extended Induction: Induction Nonresponders-300mg Miri IV-ME2
    Arm description
    		 Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg mirikizumab IV Q4W for 3 doses (ME2 Cohort).

    Number of subjects in period 2 [2]
    		Extended Induction: Induction Nonresponders - 300mg Miri IV Extended Induction: Induction Nonresponders-300mg Miri IV-ME2
    Started
    461
    66
    Completed
    271
    33
    Not completed
    190
    33
         Physician decision
    1
    -
         Consent withdrawn by subject
    6
    5
         Lack of capacity due to lack of staff
    1
    -
         Adverse event, non-fatal
    11
    1
         Covid-19 related study disruption
    4
    -
         Protocol Violation
    5
    1
         Lack of efficacy
    162
    26
    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: Included only participants who entered open label extended induction period.
    Period 3
    Period 3 title
    Open Label Maintenance Period (Wk 12-40)
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Open Label Maintenance Period (Wk 12-40)
    Arm description
    		 Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
    Arm type
    		 Open Label Maintenance Period

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab SC Q4W.

    Arm title
    		 Open Label Maintenance:Delayed Responders- 200mg Miri SC- ME2
    Arm description
    		 Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    200 mg mirikizumab SC Q4W (ME2 Cohort).

    Number of subjects in period 3
    		Open Label Maintenance Period (Wk 12-40) Open Label Maintenance:Delayed Responders- 200mg Miri SC- ME2
    Started
    271
    33
    Completed
    256
    30
    Not completed
    15
    3
         Consent withdrawn by subject
    -
    2
         Adverse event, non-fatal
    4
    1
         Covid-19 related study disruption
    1
    -
         Protocol Violation
    1
    -
         Lack of efficacy
    9
    -
    Period 4
    Period 4 title
    Loss of Response Rescue Period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
    Arm description
    		 Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
    Arm type
    		 LOR Rescue Period

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg mirikizumab IV Q4W.

    Arm title
    		 LOR Rescue Period:LOR Cohort-300 mg Miri IV - ME2 Cohort
    Arm description
    		 Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    300 mg mirikizumab IV Q4W (ME2 Cohort).

    Number of subjects in period 4 [3]
    		Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV LOR Rescue Period:LOR Cohort-300 mg Miri IV - ME2 Cohort
    Started
    90
    12
    Completed
    81
    9
    Not completed
    9
    3
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    2
    -
         Pregnancy
    1
    -
         Rolled Over to Study I6T‑MC‑AMAP (NCT03519945)
    -
    2
         Lack of efficacy
    5
    1
    Notes
    [3] - 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: Included only participants who experienced loss of response and were eligible for loss of response rescue induction.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC)
    Reporting group description
    		 Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Reporting group description
    		 Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: PBO IR - PBO SC
    Reporting group description
    		 Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: PBO IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC Maintenance Period: PBO IR - PBO SC Maintenance Period: Miri IR - PBO SC - ME2 Cohort Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort Maintenance Period: PBO IR - PBO SC - ME2 Cohort Total
    Number of subjects
    		 192 389 135 21 52 12 801
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: years
        arithmetic mean (standard deviation)
    		 41.20 ( 12.88 ) 43.30 ( 14.13 ) 40.80 ( 13.40 ) 49.10 ( 10.71 ) 42.50 ( 13.90 ) 56.20 ( 14.01 ) -
    Gender categorical
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        Female
    		 78 160 61 6 23 5 333
        Male
    		 114 229 74 15 29 7 468
    Ethnicity
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1). Ethnicity data collected only for United States (US) participants.
    Units: Subjects
        Hispanic or Latino
    		 2 12 2 16
        Not Hispanic or Latino
    		 18 33 8 59
        Unknown or Not Reported
    		 172 344 125 21 52 12 726
    Race
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        American Indian or Alaska Native
    		 1 3 2 0 0 0 6
        Asian
    		 51 93 28 21 52 12 257
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0 0 0
        Black or African American
    		 0 6 0 0 0 0 6
        White
    		 138 285 103 0 0 0 526
        More than one race
    		 0 0 2 0 0 0 2
        Unknown or Not Reported
    		 2 2 0 0 0 0 4
    Region of Enrollment
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        Argentina
    		 1 5 0 0 0 0 6
        Australia
    		 0 3 0 0 0 0 3
        Austria
    		 2 2 0 0 0 0 4
        Belgium
    		 1 2 2 0 0 0 5
        Canada
    		 3 5 2 0 0 0 10
        China
    		 3 4 1 21 52 12 93
        Czechia
    		 7 19 11 0 0 0 37
        Denmark
    		 3 3 0 0 0 0 6
        France
    		 10 18 6 0 0 0 34
        Germany
    		 5 13 3 0 0 0 21
        Hungary
    		 1 8 2 0 0 0 11
        India
    		 18 25 16 0 0 0 59
        Ireland
    		 0 1 0 0 0 0 1
        Israel
    		 3 6 1 0 0 0 10
        Italy
    		 3 12 4 0 0 0 19
        Japan
    		 25 47 8 0 0 0 80
        Latvia
    		 8 10 3 0 0 0 21
        Lithuania
    		 6 4 5 0 0 0 15
        Malaysia
    		 0 3 0 0 0 0 3
        Mexico
    		 1 3 2 0 0 0 6
        Netherlands
    		 1 6 0 0 0 0 7
        Poland
    		 15 32 13 0 0 0 60
        Romania
    		 4 2 0 0 0 0 6
        Russia
    		 19 36 16 0 0 0 71
        Serbia
    		 1 9 4 0 0 0 14
        Slovakia
    		 6 7 1 0 0 0 14
        South Korea
    		 3 8 1 0 0 0 12
        Spain
    		 1 6 4 0 0 0 11
        Switzerland
    		 0 4 0 0 0 0 4
        Taiwan
    		 1 1 0 0 0 0 2
        Turkey
    		 0 5 2 0 0 0 7
        Ukraine
    		 18 31 16 0 0 0 65
        United Kingdom
    		 2 4 2 0 0 0 8
        United States
    		 21 45 10 0 0 0 76
    Subject analysis sets

    Subject analysis set title
    200 Milligram (mg) Miri SC
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received 200 mg mirikizumab SC every Q4W.

    Subject analysis set title
    Extended Induction: Induction Nonresponders - 300mg Miri IV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Subject analysis set title
    Extended Induction Induction Nonresponders-300mg Miri IV - ME2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Subject analysis sets values
    		 200 Milligram (mg) Miri SC Extended Induction: Induction Nonresponders - 300mg Miri IV Extended Induction Induction Nonresponders-300mg Miri IV - ME2
    Number of subjects
    652
    461
    66
    Age categorical
    Units: Subjects
    Age continuous
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: years
        arithmetic mean (standard deviation)
    ( )
    43.40 ( 13.86 )
    44.40 ( 14.82 )
    Gender categorical
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        Female
    166
    18
        Male
    295
    48
    Ethnicity
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1). Ethnicity data collected only for United States (US) participants.
    Units: Subjects
        Hispanic or Latino
    11
    0
        Not Hispanic or Latino
    53
    0
        Unknown or Not Reported
    397
    66
    Race
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        American Indian or Alaska Native
    4
    0
        Asian
    87
    66
        Native Hawaiian or Other Pacific Islander
    1
    0
        Black or African American
    6
    0
        White
    358
    0
        More than one race
    1
    0
        Unknown or Not Reported
    4
    0
    Region of Enrollment
    All randomized participants who are responders to Miri and PBO in induction study (LUCENT-1).
    Units: Subjects
        Argentina
    5
    0
        Australia
    9
    0
        Austria
    4
    0
        Belgium
    4
    0
        Canada
    21
    0
        China
    7
    66
        Czechia
    15
    0
        Denmark
    1
    0
        France
    23
    0
        Germany
    16
    0
        Hungary
    12
    0
        India
    13
    0
        Ireland
    0
    0
        Israel
    5
    0
        Italy
    17
    0
        Japan
    43
    0
        Latvia
    8
    0
        Lithuania
    7
    0
        Malaysia
    3
    0
        Mexico
    4
    0
        Netherlands
    3
    0
        Poland
    62
    0
        Romania
    8
    0
        Russia
    29
    0
        Serbia
    7
    0
        Slovakia
    7
    0
        South Korea
    13
    0
        Spain
    9
    0
        Switzerland
    6
    0
        Taiwan
    1
    0
        Turkey
    1
    0
        Ukraine
    28
    0
        United Kingdom
    6
    0
        United States
    64
    0

    End points

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    End points reporting groups
    Reporting group title
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC)
    Reporting group description
    		 Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Reporting group description
    		 Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: PBO IR - PBO SC
    Reporting group description
    		 Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: PBO IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
    Reporting group title
    Extended Induction: Induction Nonresponders - 300mg Miri IV
    Reporting group description
    		 Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Reporting group title
    Extended Induction: Induction Nonresponders-300mg Miri IV-ME2
    Reporting group description
    		 Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
    Reporting group title
    Open Label Maintenance Period (Wk 12-40)
    Reporting group description
    		 Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).

    Reporting group title
    Open Label Maintenance:Delayed Responders- 200mg Miri SC- ME2
    Reporting group description
    		 Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
    Reporting group title
    Loss of Response (LOR) Rescue Period:LOR Cohort-300 mg Miri IV
    Reporting group description
    		 Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.

    Reporting group title
    LOR Rescue Period:LOR Cohort-300 mg Miri IV - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.

    Subject analysis set title
    200 Milligram (mg) Miri SC
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants who received 200 mg mirikizumab SC every Q4W.

    Subject analysis set title
    Extended Induction: Induction Nonresponders - 300mg Miri IV
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Subject analysis set title
    Extended Induction Induction Nonresponders-300mg Miri IV - ME2
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Primary: Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders) [1]
    End point description
    Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). Analysis population description (APD): Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Primary
    End point timeframe
    Week 40
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    25.1 (18.8 to 31.5)
    49.9 (44.7 to 55.0)
    Statistical analysis title
    		 Percentage of Participants in Clinical Remission
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 15.2
         upper limit
    		 31.2

    Secondary: Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders) [2]
    End point description
    Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 40
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    29.1 (22.4 to 35.7)
    58.6 (53.6 to 63.7)
    Statistical analysis title
    		 Percentage of Participants in Endoscopic Remission
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    28.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.2
         upper limit
    		 36.8

    Secondary: Percentage of Participants with Histologic Remission at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants with Histologic Remission at Week 40 (Mirikizumab Induction Responders) [3]
    End point description
    Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis. Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration). APD: Modified Intention-to-treat population (mITT): All randomized participants (pts) who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 40
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    24.6 (18.3 to 30.9)
    48.5 (43.4 to 53.6)
    Statistical analysis title
    		 Percentage of Pts with Histologic Remission
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    22.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 14.5
         upper limit
    		 30.5

    Secondary: Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders) [4]
    End point description
    Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline. Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 40
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    39.7 (32.5 to 46.8)
    71.0 (66.3 to 75.6)
    Statistical analysis title
    		 Percentage of Pts in Symptomatic Remission
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    30.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.9
         upper limit
    		 38.6

    Secondary: Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders) [5]
    End point description
    Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore. APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 40
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    40.8 (33.6 to 48.0)
    72.6 (68.0 to 77.2)
    Statistical analysis title
    		 Percentage of Participants in Endoscopic Response
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.4
         upper limit
    		 39.6

    Secondary: Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders) [6]
    End point description
    Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of >= 2 points and >=30% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration). APD: mITT: All randomized participants who received at least one dose of study drug and who had the modified Mayo score measured correctly at baseline.
    End point type
    Secondary
    End point timeframe
    Week 40 Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (confidence interval 95%)
    49.2 (41.8 to 56.5)
    80.3 (76.2 to 84.4)
    Statistical analysis title
    		 Percentage of Participants in Clinical Response
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    30.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 22.3
         upper limit
    		 38.9

    Secondary: Change from Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)

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    End point title
    		 Change from Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders) [7]
    End point description
    The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point. Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." Scores range from 32 to 224; a higher score indicates a better quality of life. Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other). Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Induction Baseline, Week 40 APD: mITT: All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline IBDQ measurement.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: score on a scale
        least squares mean (standard error)
    24.51 ( 2.767 )
    49.75 ( 2.102 )
    Statistical analysis title
    		 Change from Baseline to Week 40 in IBDQ
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [8]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    25.24
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.16
         upper limit
    		 31.32
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.094
    Notes
    [8] - ANCOVA with modified baseline observation carried forward (mBOCF).

    Secondary: Change from Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)

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    End point title
    		 Change from Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders) [9]
    End point description
    Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation. Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12. APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline fecal calprotectin measurement. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Induction Baseline, Week 40
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: milligram per kilogram (mg/kg)
        least squares mean (standard error)
    -1155.82 ( 221.394 )
    -1995.47 ( 172.443 )
    Statistical analysis title
    		 Change from Baseline in Fecal Calprotectin
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    544
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [10]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -839.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1323.08
         upper limit
    		 -356.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    245.99
    Notes
    [10] - ANCOVA with modified baseline observation carried forward (mBOCF).

    Secondary: Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)

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    End point title
    		 Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders) [11]
    End point description
    The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency). Higher scores indicate more severe urgency. Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other). Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Induction Baseline, Week 40 APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least 1 dose of study drug and had a baseline and at least one post-baseline urgency NRS measurement.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    104
    316
    Units: score on a scale
        least squares mean (standard error)
    -2.74 ( 0.202 )
    -3.80 ( 0.139 )
    Statistical analysis title
    		 Change From Baseline to Week 40 in NRS
    Comparison groups
    Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) v Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LS Mean difference (Final Values)
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.51
         upper limit
    		 -0.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.228

    Secondary: Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)

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    End point title
    		 Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders) [12]
    End point description
    Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded. APD: Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of study drug. Participants were analysed per their assigned treatment arm regardless of the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Week 40
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint is reported only for randomized arms as described in the protocol.
    End point values
    		 Maintenance Period: Miri IR - Placebo (PBO) Subcutaneous (SC) Maintenance Period: Miri IR - 200 Milligram (mg) Miri SC
    Number of subjects analysed
    179
    365
    Units: percentage of participants
        number (not applicable)
    1.1
    0
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK): Clearance of Mirikizumab

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    End point title
    		 Pharmacokinetics (PK): Clearance of Mirikizumab
    End point description
    Clearance of mirikizumab was evaluated. APD: All randomized participants who received at least one dose of study drug subcutaneously (both induction responders and nonresponders) and had evaluable PK data.
    End point type
    Secondary
    End point timeframe
    Predose: Weeks 0, 4, 12, 24 and 40
    End point values
    		 200 Milligram (mg) Miri SC
    Number of subjects analysed
    652
    Units: Liters per Hour (L/h)
        geometric mean (geometric coefficient of variation)
    0.0487 ( 54 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up to week 56
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug. Gender-specific events occurring exclusively in female participants have had the number of participants at risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Maintenance Period: PBO IR - PBO SC
    Reporting group description
    		 Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 mg Miri SC
    Reporting group description
    		 Participants who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: PBO IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - PBO SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Open Label Maintenance:Delayed Responders-200 mg Miri SC-ME2
    Reporting group description
    		 Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).

    Reporting group title
    LOR Rescue Period: LOR Cohort-300 mg Miri IV
    Reporting group description
    		 Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab IV Q4W for 3 doses.

    Reporting group title
    LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab IV Q4W for 3 doses.

    Reporting group title
    Extended Induction: Induction Nonresponders - 300mg Miri IV
    Reporting group description
    		 Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Reporting group title
    Extended Induction: Induction Nonresponders-300mg Miri IV-ME2
    Reporting group description
    		 Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.

    Reporting group title
    Open Label Maintenance: Delayed Responders - 200 mg Miri SC
    Reporting group description
    		 Participants who initially did not respond to induction study (LUCENT-1) but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).

    Reporting group title
    Maintenance Period: Miri IR - PBO SC
    Reporting group description
    		 Participants who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.

    Reporting group title
    Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Reporting group description
    		 Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.

    Serious adverse events
    		 Maintenance Period: PBO IR - PBO SC Maintenance Period: Miri IR - 200 mg Miri SC Maintenance Period: PBO IR - PBO SC - ME2 Cohort Maintenance Period: Miri IR - PBO SC - ME2 Cohort Open Label Maintenance:Delayed Responders-200 mg Miri SC-ME2 LOR Rescue Period: LOR Cohort-300 mg Miri IV LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort Extended Induction: Induction Nonresponders - 300mg Miri IV Extended Induction: Induction Nonresponders-300mg Miri IV-ME2 Open Label Maintenance: Delayed Responders - 200 mg Miri SC Maintenance Period: Miri IR - PBO SC Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 135 (5.93%)
    13 / 389 (3.34%)
    1 / 12 (8.33%)
    4 / 21 (19.05%)
    3 / 33 (9.09%)
    3 / 90 (3.33%)
    2 / 12 (16.67%)
    24 / 461 (5.21%)
    4 / 66 (6.06%)
    9 / 271 (3.32%)
    16 / 192 (8.33%)
    7 / 52 (13.46%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    adenocarcinoma of colon
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    colorectal adenoma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    gastric cancer
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    kaposi's sarcoma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    lipoma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    neuroendocrine tumour
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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 / 0
    1 / 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
    0 / 0
    plasmablastic lymphoma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    rectal cancer
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    thyroid cancer
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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 / 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
    0 / 0
    Vascular disorders
    deep vein thrombosis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    granulomatosis with polyangiitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    hypovolaemic shock
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Surgical and medical procedures
    colectomy total
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    proctocolectomy
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    retinopexy
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    tooth extraction
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    abortion missed
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed [1]
    1 / 61 (1.64%)
    0 / 160 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 43 (0.00%)
    0 / 7 (0.00%)
    0 / 166 (0.00%)
    0 / 18 (0.00%)
    0 / 111 (0.00%)
    0 / 78 (0.00%)
    0 / 23 (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
    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
    0 / 0
    Immune system disorders
    anaphylactic reaction
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    Reproductive system and breast disorders
    rectocele
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed [2]
    0 / 61 (0.00%)
    1 / 160 (0.63%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 43 (0.00%)
    0 / 7 (0.00%)
    0 / 166 (0.00%)
    0 / 18 (0.00%)
    0 / 111 (0.00%)
    0 / 78 (0.00%)
    0 / 23 (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
    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
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    Psychiatric disorders
    depression suicidal
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    neurologic somatic symptom disorder
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Investigations
    blood glucose increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    human chorionic gonadotropin increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Injury, poisoning and procedural complications
    anastomotic fistula
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    1 / 66 (1.52%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    brain contusion
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    compression fracture
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    patella fracture
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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 / 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
    0 / 0
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (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 / 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
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    ischaemic stroke
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    migraine
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    presyncope
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    Blood and lymphatic system disorders
    immune thrombocytopenia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    Eye disorders
    maculopathy
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    retinal detachment
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Gastrointestinal disorders
    anorectal polyp
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    colitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    colitis ulcerative
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    2 / 33 (6.06%)
    1 / 90 (1.11%)
    1 / 12 (8.33%)
    9 / 461 (1.95%)
    2 / 66 (3.03%)
    3 / 271 (1.11%)
    7 / 192 (3.65%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    1 / 2
    0 / 2
    1 / 1
    1 / 1
    0 / 9
    1 / 2
    2 / 3
    0 / 7
    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
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    gastritis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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 / 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
    0 / 0
    ileus
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    inguinal hernia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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 / 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
    0 / 0
    intestinal obstruction
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    1 / 66 (1.52%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    large intestine perforation
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    large intestine polyp
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    1 / 66 (1.52%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    peptic ulcer
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    pneumoperitoneum
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    rectal haemorrhage
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    Skin and subcutaneous tissue disorders
    pruritus
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    xanthelasma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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 / 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
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    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
    0 / 0
    ureterolithiasis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    0 / 0
    Endocrine disorders
    autoimmune thyroiditis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    back pain
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    sacral pain
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Infections and infestations
    abdominal abscess
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    anal abscess
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    bacillus infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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 / 1
    0 / 0
    covid-19 pneumonia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    campylobacter gastroenteritis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    clostridium difficile infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    cytomegalovirus colitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    escherichia infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    gastroenteritis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    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
    0 / 0
    influenza
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         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
    1 / 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
    0 / 0
    klebsiella infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    large intestine infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    1 / 3
    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
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    subcutaneous abscess
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    tonsillitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    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
    0 / 0
    Metabolism and nutrition disorders
    hypoglycaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    0 / 52 (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 / 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
    0 / 0
    hypokalaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (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
    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
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender-specific events occurring exclusively in female participants have had the number of participants at risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender-specific events occurring exclusively in female participants have had the number of participants at risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Maintenance Period: PBO IR - PBO SC Maintenance Period: Miri IR - 200 mg Miri SC Maintenance Period: PBO IR - PBO SC - ME2 Cohort Maintenance Period: Miri IR - PBO SC - ME2 Cohort Open Label Maintenance:Delayed Responders-200 mg Miri SC-ME2 LOR Rescue Period: LOR Cohort-300 mg Miri IV LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort Extended Induction: Induction Nonresponders - 300mg Miri IV Extended Induction: Induction Nonresponders-300mg Miri IV-ME2 Open Label Maintenance: Delayed Responders - 200 mg Miri SC Maintenance Period: Miri IR - PBO SC Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 135 (42.96%)
    143 / 389 (36.76%)
    10 / 12 (83.33%)
    16 / 21 (76.19%)
    13 / 33 (39.39%)
    18 / 90 (20.00%)
    4 / 12 (33.33%)
    74 / 461 (16.05%)
    22 / 66 (33.33%)
    91 / 271 (33.58%)
    82 / 192 (42.71%)
    32 / 52 (61.54%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    uterine leiomyoma
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed [3]
    0 / 61 (0.00%)
    0 / 160 (0.00%)
    0 / 5 (0.00%)
    0 / 6 (0.00%)
    1 / 7 (14.29%)
    0 / 43 (0.00%)
    0 / 7 (0.00%)
    0 / 166 (0.00%)
    0 / 18 (0.00%)
    0 / 111 (0.00%)
    0 / 78 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    hypotension
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    2 / 192 (1.04%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    2
    0
    General disorders and administration site conditions
    oedema peripheral
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 389 (0.51%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    1 / 12 (8.33%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    2 / 271 (0.74%)
    1 / 192 (0.52%)
    0 / 52 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    1
    1
    1
    0
    3
    1
    0
    pyrexia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    6 / 135 (4.44%)
    13 / 389 (3.34%)
    1 / 12 (8.33%)
    1 / 21 (4.76%)
    1 / 33 (3.03%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    0 / 66 (0.00%)
    6 / 271 (2.21%)
    5 / 192 (2.60%)
    3 / 52 (5.77%)
         occurrences all number
    8
    14
    1
    1
    1
    1
    0
    3
    0
    7
    7
    3
    Respiratory, thoracic and mediastinal disorders
    pulmonary mass
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    4 / 389 (1.03%)
    0 / 12 (0.00%)
    2 / 21 (9.52%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    2 / 66 (3.03%)
    0 / 271 (0.00%)
    1 / 192 (0.52%)
    1 / 52 (1.92%)
         occurrences all number
    1
    4
    0
    4
    0
    1
    0
    0
    2
    0
    1
    1
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    3 / 389 (0.77%)
    0 / 12 (0.00%)
    2 / 21 (9.52%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    1 / 66 (1.52%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    3
    0
    4
    0
    1
    0
    1
    1
    1
    0
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    2 / 33 (6.06%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    2 / 271 (0.74%)
    3 / 192 (1.56%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    1
    0
    2
    3
    1
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    5 / 135 (3.70%)
    10 / 389 (2.57%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    1 / 66 (1.52%)
    3 / 271 (1.11%)
    5 / 192 (2.60%)
    1 / 52 (1.92%)
         occurrences all number
    5
    11
    1
    0
    0
    0
    0
    3
    1
    3
    6
    1
    weight increased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    2 / 33 (6.06%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    1
    1
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    weight decreased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    2 / 135 (1.48%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 389 (0.77%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    1 / 192 (0.52%)
    3 / 52 (5.77%)
         occurrences all number
    1
    4
    0
    0
    2
    0
    0
    0
    0
    1
    2
    3
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    sinus bradycardia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    ventricular extrasystoles
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    dizziness
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    2 / 90 (2.22%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    1 / 66 (1.52%)
    1 / 271 (0.37%)
    1 / 192 (0.52%)
    1 / 52 (1.92%)
         occurrences all number
    0
    1
    1
    0
    0
    2
    0
    3
    3
    1
    1
    1
    headache
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    5 / 135 (3.70%)
    16 / 389 (4.11%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    5 / 90 (5.56%)
    0 / 12 (0.00%)
    8 / 461 (1.74%)
    1 / 66 (1.52%)
    13 / 271 (4.80%)
    2 / 192 (1.04%)
    2 / 52 (3.85%)
         occurrences all number
    18
    21
    0
    1
    0
    5
    0
    10
    3
    21
    5
    4
    sleep deficit
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    8 / 135 (5.93%)
    8 / 389 (2.06%)
    2 / 12 (16.67%)
    3 / 21 (14.29%)
    1 / 33 (3.03%)
    5 / 90 (5.56%)
    0 / 12 (0.00%)
    7 / 461 (1.52%)
    4 / 66 (6.06%)
    9 / 271 (3.32%)
    9 / 192 (4.69%)
    2 / 52 (3.85%)
         occurrences all number
    11
    8
    3
    3
    1
    5
    0
    7
    4
    9
    12
    2
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    3 / 135 (2.22%)
    11 / 389 (2.83%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    0 / 66 (0.00%)
    3 / 271 (1.11%)
    4 / 192 (2.08%)
    4 / 52 (7.69%)
         occurrences all number
    3
    13
    0
    0
    0
    0
    0
    3
    0
    5
    4
    4
    anorectal polyp
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    2 / 33 (6.06%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    2 / 192 (1.04%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    1
    0
    0
    2
    0
    colitis ulcerative
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    17 / 135 (12.59%)
    26 / 389 (6.68%)
    3 / 12 (25.00%)
    6 / 21 (28.57%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    4 / 461 (0.87%)
    1 / 66 (1.52%)
    10 / 271 (3.69%)
    35 / 192 (18.23%)
    4 / 52 (7.69%)
         occurrences all number
    18
    30
    3
    6
    1
    0
    0
    4
    1
    11
    35
    5
    diarrhoea
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    3 / 135 (2.22%)
    10 / 389 (2.57%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    2 / 33 (6.06%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    2 / 461 (0.43%)
    1 / 66 (1.52%)
    8 / 271 (2.95%)
    1 / 192 (0.52%)
    1 / 52 (1.92%)
         occurrences all number
    3
    10
    0
    0
    3
    0
    0
    2
    1
    9
    1
    1
    haemorrhoids
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    2 / 135 (1.48%)
    5 / 389 (1.29%)
    0 / 12 (0.00%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    1 / 461 (0.22%)
    1 / 66 (1.52%)
    6 / 271 (2.21%)
    3 / 192 (1.56%)
    1 / 52 (1.92%)
         occurrences all number
    2
    5
    0
    1
    0
    0
    1
    1
    1
    6
    3
    1
    large intestine polyp
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 389 (0.77%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    1 / 461 (0.22%)
    1 / 66 (1.52%)
    0 / 271 (0.00%)
    2 / 192 (1.04%)
    0 / 52 (0.00%)
         occurrences all number
    2
    3
    0
    0
    1
    0
    1
    1
    1
    0
    2
    0
    Skin and subcutaneous tissue disorders
    papule
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    thyroiditis subacute
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    4 / 135 (2.96%)
    26 / 389 (6.68%)
    1 / 12 (8.33%)
    1 / 21 (4.76%)
    0 / 33 (0.00%)
    3 / 90 (3.33%)
    0 / 12 (0.00%)
    15 / 461 (3.25%)
    1 / 66 (1.52%)
    19 / 271 (7.01%)
    8 / 192 (4.17%)
    1 / 52 (1.92%)
         occurrences all number
    4
    27
    2
    1
    0
    5
    0
    15
    1
    24
    8
    1
    back pain
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    4 / 135 (2.96%)
    6 / 389 (1.54%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    1 / 66 (1.52%)
    3 / 271 (1.11%)
    4 / 192 (2.08%)
    0 / 52 (0.00%)
         occurrences all number
    4
    6
    1
    0
    0
    0
    0
    0
    1
    3
    4
    0
    osteoarthritis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 389 (0.51%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    neck pain
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 389 (0.77%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    1 / 192 (0.52%)
    0 / 52 (0.00%)
         occurrences all number
    1
    3
    1
    0
    0
    1
    0
    0
    0
    1
    1
    0
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    5 / 135 (3.70%)
    8 / 389 (2.06%)
    1 / 12 (8.33%)
    3 / 21 (14.29%)
    1 / 33 (3.03%)
    1 / 90 (1.11%)
    1 / 12 (8.33%)
    4 / 461 (0.87%)
    4 / 66 (6.06%)
    6 / 271 (2.21%)
    4 / 192 (2.08%)
    6 / 52 (11.54%)
         occurrences all number
    5
    8
    1
    3
    1
    1
    1
    4
    4
    6
    4
    6
    bronchitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    4 / 389 (1.03%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    4
    1
    0
    1
    0
    0
    1
    0
    1
    0
    1
    clostridium difficile infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    1 / 389 (0.26%)
    0 / 12 (0.00%)
    2 / 21 (9.52%)
    1 / 33 (3.03%)
    2 / 90 (2.22%)
    0 / 12 (0.00%)
    4 / 461 (0.87%)
    3 / 66 (4.55%)
    3 / 271 (1.11%)
    3 / 192 (1.56%)
    0 / 52 (0.00%)
         occurrences all number
    1
    1
    0
    3
    1
    2
    0
    5
    3
    4
    4
    0
    gastrointestinal infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    1 / 389 (0.26%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    1 / 33 (3.03%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    1 / 135 (0.74%)
    3 / 389 (0.77%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    2 / 461 (0.43%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    4 / 52 (7.69%)
         occurrences all number
    1
    3
    0
    0
    0
    0
    0
    2
    0
    0
    0
    4
    localised infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    9 / 135 (6.67%)
    28 / 389 (7.20%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    15 / 461 (3.25%)
    0 / 66 (0.00%)
    14 / 271 (5.17%)
    11 / 192 (5.73%)
    3 / 52 (5.77%)
         occurrences all number
    12
    38
    0
    0
    0
    1
    0
    15
    0
    15
    11
    3
    upper respiratory tract infection
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    2 / 135 (1.48%)
    7 / 389 (1.80%)
    1 / 12 (8.33%)
    4 / 21 (19.05%)
    4 / 33 (12.12%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    3 / 461 (0.65%)
    6 / 66 (9.09%)
    9 / 271 (3.32%)
    5 / 192 (2.60%)
    8 / 52 (15.38%)
         occurrences all number
    2
    9
    3
    5
    5
    1
    0
    3
    6
    9
    6
    12
    Metabolism and nutrition disorders
    electrolyte imbalance
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    hyperkalaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    1 / 12 (8.33%)
    0 / 21 (0.00%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    0 / 12 (0.00%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    1 / 271 (0.37%)
    2 / 192 (1.04%)
    0 / 52 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    1
    2
    0
    hypoalbuminaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    0 / 389 (0.00%)
    0 / 12 (0.00%)
    2 / 21 (9.52%)
    0 / 33 (0.00%)
    0 / 90 (0.00%)
    1 / 12 (8.33%)
    0 / 461 (0.00%)
    0 / 66 (0.00%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    1 / 52 (1.92%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    1
    hypokalaemia
    alternative dictionary used: MedDRA 28.0
         subjects affected / exposed
    0 / 135 (0.00%)
    2 / 389 (0.51%)
    1 / 12 (8.33%)
    2 / 21 (9.52%)
    1 / 33 (3.03%)
    1 / 90 (1.11%)
    0 / 12 (0.00%)
    1 / 461 (0.22%)
    4 / 66 (6.06%)
    0 / 271 (0.00%)
    0 / 192 (0.00%)
    0 / 52 (0.00%)
         occurrences all number
    0
    2
    1
    4
    4
    1
    0
    1
    4
    0
    0
    0
    Notes
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender-specific events occurring exclusively in female participants have had the number of participants at risk adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Sep 2019
    • Replaced Primary objective, major secondary objectives, added Other secondary objectives • Added: 50% biological 50% conventional failure split • Follicle stimulating hormone (FSH) testing optional in women to confirm nonchild-bearing potential • Clarified infusion-reaction related samples • Clarified collection of Endoscopy • Clarified conditions when patients perform health outcome assessments • Clarified when informed consent form (ICF) be obtained • Clarified schedule of activities • Minimized study procedures for participants • Visit window changed between AMAN and AMBG • Clarification of Inclusion Criteria • Added assessments if drug hypersensitivity event observed • Changed the term Study treatment to study drug as study drug is blinded • Clarified term “mucosal healing” • Primary endpoint terminology changed from “durable clinical remission” to “clinical remission”; “remission changed to response” with mirikizumab induction treatment for clarification of treatment • Text deleted for medical monitor consult for endoscopy findings • Added when early termination visit (ETV) endoscopy should be discussed with the medical monitor. • Added Centers for Disease Control and Prevention guidance (CDC) was for the United States (US) and the World Health Organization (WHO) was for countries outside of the US • Deleted clinical study report (CSR) coordinating investigator “with the most enrolled participant's” will be selected by the study team • Clarified use of permitted and prohibited Medications

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

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