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    Clinical Trial Results:
    Protocol I6T-MC-AMAF A Phase 2, Multicenter, Randomized, Parallel-arm, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2016-001098-34
    Trial protocol
    		 DE   PL  
    Global end of trial date
    08 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 May 2020
    First version publication date
    21 May 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I6T-MC-AMAF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02899988
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16481
    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
    08 May 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.
    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
    14 Sep 2016
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 4 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    United States: 82
    Country: Number of subjects enrolled
    Japan: 20
    Country: Number of subjects enrolled
    Poland: 65
    Country: Number of subjects enrolled
    Germany: 15
    Worldwide total number of subjects
    205
    EEA total number of subjects
    80
    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)
    183
    From 65 to 84 years
    22
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 No Text Available

    Pre-assignment
    Screening details
    		 No Text Available

    Period 1
    Period 1 title
    Induction Period (16 Weeks)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Induction: Placebo
    Arm description
    		 Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo subcutaneously (SC) every 8 weeks (Q8W).

    Arm title
    		 Induction: 30 mg Mirikizumab Q8W
    Arm description
    		 Induction: Participants received 30 mg mirikizumab SC Q8W during Induction period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg mirikizumab SC Q8W.

    Arm title
    		 Induction:100 mg Mirikizumab Q8W
    Arm description
    		 Induction:Participants received 100 mg mirikizumab SC Q8W during Induction period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg mirikizumab SC Q8W.

    Arm title
    		 Induction: 300 mg Mirikizumab Q8W
    Arm description
    		 Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab SC Q8W.

    Number of subjects in period 1
    		Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Started
    52
    51
    51
    51
    Received at least one dose of study drug
    52
    51
    51
    51
    Completed
    50
    49
    51
    49
    Not completed
    2
    2
    0
    2
         Consent withdrawn by subject
    2
    1
    -
    -
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    -
    -
    -
    2
    Period 2
    Period 2 title
    Maintenance Period (88 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ Psoriasis Area and Severity Index ( PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg mirikizumab as needed (PRN).

    Arm title
    		 Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    100 mg mirikizumab as needed (PRN).

    Arm title
    		 Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab as needed (PRN).

    Arm title
    		 Maintenance: Placebo to 300 mg Mirikizumab Q8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period. Follow-up: Participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab Q8W.

    Arm title
    		 Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: Participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab Q8W.

    Arm title
    		 Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab Q8W.

    Arm title
    		 Maintenance: 300 mg Mirikizumab Q8W
    Arm description
    		 Maintenance: Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    LY3074828
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 mg mirikizumab SC Q8W.

    Number of subjects in period 2
    		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN Maintenance: Placebo to 300 mg Mirikizumab Q8W Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W Maintenance: 300 mg Mirikizumab Q8W
    Started
    15
    30
    34
    50
    34
    21
    15
    Rescue Participants
    0 [1]
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    0 [6]
    0 [7]
    Roll over to AMAH (NCT03556202)
    9 [8]
    18 [9]
    26 [10]
    42 [11]
    24 [12]
    17 [13]
    0 [14]
    Completed
    13
    27
    30
    45
    30
    19
    13
    Not completed
    2
    3
    4
    5
    4
    2
    2
         Consent withdrawn by subject
    1
    -
    3
    2
    2
    -
    1
         Adverse event, non-fatal
    1
    2
    1
    2
    2
    2
    1
         Lost to follow-up
    -
    1
    -
    1
    -
    -
    -
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [10] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [11] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started to maintenance period.
    [12] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [13] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    [14] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: It's a milestone independent of the number that started maintenance period.
    Period 3
    Period 3 title
    Follow-Up (16 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maintenance: Placebo to 300 mg Mirikizumab Q8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period. Follow-up: Participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: Participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Arm description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [15]
    		Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN Maintenance: Placebo to 300 mg Mirikizumab Q8W Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Started
    2
    2
    3
    3
    6
    2
    Completed
    2
    2
    3
    3
    6
    2
    Notes
    [15] - 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: Not all participants that completed maintenance period continued to follow-up period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Induction: Placebo
    Reporting group description
    		 Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.

    Reporting group title
    Induction: 30 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 30 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Induction:100 mg Mirikizumab Q8W
    Reporting group description
    		 Induction:Participants received 100 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Induction: 300 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.

    Reporting group values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W Total
    Number of subjects
    		 52 51 51 51 205
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 46.0 ± 12.39 49.2 ± 13.28 46.0 ± 13.18 47.5 ± 13.23 -
    Gender categorical
    Units: Subjects
        Female
    		 10 12 16 15 53
        Male
    		 42 39 35 36 152
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 7 4 5 24
        Not Hispanic or Latino
    		 39 37 42 42 160
        Unknown or Not Reported
    		 5 7 5 4 21
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0 0
        Asian
    		 6 7 7 6 26
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 1 1 3 3 8
        White
    		 44 43 41 42 170
        More than one race
    		 1 0 0 0 1
        Unknown or Not Reported
    		 0 0 0 0 0
    Region of Enrollment
    Units: Subjects
        Canada
    		 4 7 7 5 23
        United States
    		 21 20 18 23 82
        Japan
    		 4 7 5 4 20
        Poland
    		 19 14 18 14 65
        Germany
    		 4 3 3 5 15

    End points

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    End points reporting groups
    Reporting group title
    Induction: Placebo
    Reporting group description
    		 Induction: Participants received placebo subcutaneously (SC) every 8 weeks (Q8W) during Induction period.

    Reporting group title
    Induction: 30 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 30 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Induction:100 mg Mirikizumab Q8W
    Reporting group description
    		 Induction:Participants received 100 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Induction: 300 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.
    Reporting group title
    Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ Psoriasis Area and Severity Index ( PASI) 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: Placebo to 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period. Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.
    Reporting group title
    Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: Placebo to 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period. Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period. Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period. Follow-up: participants did not receive drug during the follow-up period.

    Subject analysis set title
    Induction: 30 mg Mirikizumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Induction: 30 mg Mirikizumab administered SC every 8 weeks (Q8W).

    Subject analysis set title
    Induction: 100 mg Mirikizumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Induction: 100 mg Mirikizumab administered SC Q8W.

    Subject analysis set title
    Induction: 300 mg Mirikizumab
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Induction: 300 mg Mirikizumab administered SC Q8W.

    Subject analysis set title
    30 mg mirikizumab Q8W To 30 mg mirikizumab PRN
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.

    Subject analysis set title
    100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.

    Subject analysis set title
    300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.

    Subject analysis set title
    Placebo to 300 mg Mirikizumab Q8W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.

    Subject analysis set title
    30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.

    Subject analysis set title
    100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.

    Subject analysis set title
    300 mg mirikizumab SC Q8W To 300 mg mirikizumab SC Q8W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received 300 mg mirikizumab SC Q8W during Induction period. Participants had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.

    Primary: Percentage of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)

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    End point title
    		 Percentage of Participants with a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
    End point description
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    52
    51
    51
    51
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 0)
    29.4 (16.9 to 41.9)
    58.8 (45.3 to 72.3)
    66.7 (53.7 to 79.6)
    Statistical analysis title
    		 Participants With a ≥90% Improvement in PASI 90
    Statistical analysis description
    Participants With a ≥90% Improvement in PASI 90
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    29.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 16.9
         upper limit
    		 41.9
    Statistical analysis title
    		 Participants With a ≥90% Improvement in PASI 90
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    58.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 45.3
         upper limit
    		 72.3
    Statistical analysis title
    		 Participants With a ≥90% Improvement in PASI 90
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    66.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.7
         upper limit
    		 79.6

    Secondary: Percentage of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)

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    End point title
    		 Percentage of Participants with a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
    End point description
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    52
    51
    51
    51
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 0)
    15.7 (5.7 to 25.7)
    31.4 (18.6 to 44.1)
    31.4 (18.6 to 44.1)
    Statistical analysis title
    		 Participants with a 100% Improvement in PASI 100
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.7
         upper limit
    		 25.7
    Statistical analysis title
    		 Participants with a 100% Improvement in PASI 100
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 44.1
    Statistical analysis title
    		 Participants with a 100% Improvement in PASI 100
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 44.1

    Secondary: Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)

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    End point title
    		 Percentage of Participants with a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
    End point description
    The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no PsO to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). Analysis Population Description: All participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    52
    51
    51
    51
    Units: percentage of participants
        number (confidence interval 95%)
    3.8 (0 to 9.1)
    52.9 (39.2 to 66.6)
    78.4 (67.1 to 89.7)
    74.5 (62.5 to 86.5)
    Statistical analysis title
    		 Participants With a ≥75% Improvement in PASI 75
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    22.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.62
         upper limit
    		 89.97
    Statistical analysis title
    		 Participants With a ≥75% Improvement in PASI 75
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    74.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 62.1
         upper limit
    		 87
    Statistical analysis title
    		 Participants With a ≥75% Improvement in PASI 75
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    70.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 57.6
         upper limit
    		 83.7

    Secondary: Percentage of Participants with a Static Physician Global Assessment (sPGA) 0 and 0/1

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    End point title
    		 Percentage of Participants with a Static Physician Global Assessment (sPGA) 0 and 0/1
    End point description
    The sPGA is the physician's determination of the participant's PsO lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's PsO was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 16 were considered non-responders for non-responder Imputation (NRI) analysis.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    52
    51
    51
    51
    Units: percentage of participants
    number (confidence interval 95%)
        sPGA (0)
    0 (0 to 0)
    15.7 (5.7 to 25.7)
    31.4 (18.6 to 44.1)
    31.4 (18.6 to 44.1)
        sPGA (0/1)
    1.9 (0 to 5.7)
    37.3 (24.0 to 50.5)
    70.6 (58.1 to 83.1)
    68.6 (55.9 to 81.4)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0)
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.041
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    15.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 5.7
         upper limit
    		 25.7
    Notes
    [1] - sPGA (0)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0)
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [2]
    P-value
    		 = 0.007
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 44.1
    Notes
    [2] - sPGA (0)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0)
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 = 0.008
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    31.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.6
         upper limit
    		 44.1
    Notes
    [3] - sPGA (0)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0/1)
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [4]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    35.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 21.5
         upper limit
    		 49.1
    Notes
    [4] - sPGA (0/1)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0/1)
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [5]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    68.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 55.6
         upper limit
    		 81.7
    Notes
    [5] - sPGA (0/1)
    Statistical analysis title
    		 Participants With sPGA 0 and 0/1
    Statistical analysis description
    sPGA (0/1)
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    103
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [6]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Risk difference (RD)
    Point estimate
    66.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53.4
         upper limit
    		 80
    Notes
    [6] - sPGA (0/1)

    Secondary: Mean Change from Baseline on the Psoriasis Symptom Scale (PSS)

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    End point title
    		 Mean Change from Baseline on the Psoriasis Symptom Scale (PSS)
    End point description
    The Psoriasis Symptoms Scale is a patient-administered assessment of 4 symptoms (itch,pain,stinging,and burning); 3 signs(redness,scaling, and cracking); and 1 item on the discomfort related to symptoms/signs.The overall severity for each individual symptom/sign from the patient’s psoriasis is indicated by selecting the number from a numeric rating scale(NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region [United States/Outside United States(US/OUS)], previous therapy(yes/no), baseline value,visit, and the interaction treatment-by-visit as fixed factors,covariance structure=heterogeneous autoregressive. Analysis Population Description:All participants who received at least one dose of study drug who had baseline and at least one post-baseline PSS observation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    43
    43
    44
    44
    Units: units on a scale
        least squares mean (standard error)
    -4.35 ± 2.29
    -31.19 ± 2.34
    -42.33 ± 2.37
    -33.66 ± 2.27
    Statistical analysis title
    		 Change from Baseline on PSS
    Statistical analysis description
    Change from Baseline on PSS.
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -26.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -33.27
         upper limit
    		 -20.42
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.26
    Statistical analysis title
    		 Change from Baseline on PSS
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -37.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -44.47
         upper limit
    		 -31.51
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.29
    Statistical analysis title
    		 Change from Baseline on PSS.
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -29.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -35.66
         upper limit
    		 -22.97
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.22

    Secondary: Mean Change (Improvement) from Baseline on the Patient Global Assessment (PGA)

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    End point title
    		 Mean Change (Improvement) from Baseline on the Patient Global Assessment (PGA)
    End point description
    The Patient's Global Assessment of Disease Severity is a single-item participant-reported outcome measure on which participants are asked to rate the severity of their psoriasis "today" from 0 (Clear) = no psoriasis, to 5 (Severe) = the worst their psoriasis has ever been. Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured. Analysis Population Description: All participants who received at least one dose of study drug who had baseline and at least one post-baseline Patient Global Assessment observation.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    51
    48
    51
    49
    Units: units on a scale
        least squares mean (standard error)
    0.35 ± 0.16
    2.24 ± 0.16
    2.91 ± 0.16
    2.82 ± 0.16
    Statistical analysis title
    		 Mean Change (Improvement) From Baseline on PGA
    Statistical analysis description
    Mean Change (Improvement) From Baseline on PGA
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.45
         upper limit
    		 2.34
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Mean Change (Improvement) From Baseline on PGA
    Comparison groups
    Induction:100 mg Mirikizumab Q8W v Induction: Placebo
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.23
         upper limit
    		 3
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22
    Statistical analysis title
    		 Mean Change (Improvement) From Baseline on PGA
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.03
         upper limit
    		 2.91
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.22

    Secondary: Mean Change from Baseline on the Dermatology Life Quality Index (DLQI) Total Score

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    End point title
    		 Mean Change from Baseline on the Dermatology Life Quality Index (DLQI) Total Score
    End point description
    The DLQI is patient-reported, 10-question, validated, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). Least Square (LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, geographic region (US/OUS), previous therapy (yes/no), baseline value, visit, and the interaction treatment-by-visit as fixed factors, covariance structure = unstructured.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 Analysis Population Description: All participants who received at least one dose of study drug who had baseline and at least one post-baseline DLQI observation.
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    51
    48
    51
    49
    Units: score on a scale
        least squares mean (standard error)
    -1.07 ± 0.69
    -9.19 ± 0.71
    -10.18 ± 0.69
    -9.64 ± 0.70
    Statistical analysis title
    		 Mean Change From Baseline on DLQI Total Score
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.05
         upper limit
    		 -6.19
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.98
    Statistical analysis title
    		 Mean Change From Baseline on DLQI Total Score
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -9.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.02
         upper limit
    		 -7.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.97
    Statistical analysis title
    		 Mean Change From Baseline on DLQI Total Score
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -8.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.5
         upper limit
    		 -6.65
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.98

    Secondary: Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

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    End point title
    		 Mean Change from Baseline on the 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
    End point description
    The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Least Squares Mean (LS Mean) was calculated using Analysis of covariance (ANCOVA) model with treatment, geographic region (US/OUS), and previous therapy (yes/no) as fixed factors and baseline value as covariate.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16 Analysis Population Description: All participants who received at least one dose of study drug with a baseline value and at least 1 post-baseline value.
    End point values
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W
    Number of subjects analysed
    51
    48
    51
    49
    Units: score on a scale
    least squares mean (standard error)
        MCS
    0.28 ± 0.87
    2.39 ± 0.90
    2.74 ± 0.88
    1.52 ± 0.88
        PCS
    1.23 ± 0.84
    4.58 ± 0.88
    4.40 ± 0.85
    5.09 ± 0.85
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Mental Component Summary (MCS).
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [7]
    P-value
    		 = 0.009
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.34
         upper limit
    		 4.56
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24
    Notes
    [7] - Mental Component Summary (MCS).
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Mental Component Summary (MCS).
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [8]
    P-value
    		 = 0.002
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    2.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.06
         upper limit
    		 4.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.22
    Notes
    [8] - Mental Component Summary (MCS)
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Mental Component Summary (MCS).
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [9]
    P-value
    		 = 0.087
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.19
         upper limit
    		 3.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.24
    Notes
    [9] - Mental Component Summary (MCS).
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Physical Component Summary
    Comparison groups
    Induction: Placebo v Induction: 30 mg Mirikizumab Q8W
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [10]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 5.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.2
    Notes
    [10] - Physical Component Summary
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Physical Component Summary
    Comparison groups
    Induction: Placebo v Induction:100 mg Mirikizumab Q8W
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [11]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 5.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.18
    Notes
    [11] - Physical Component Summary
    Statistical analysis title
    		 Mean Change From Baseline on SF-36 PCS and MCS
    Statistical analysis description
    Physical Component Summary
    Comparison groups
    Induction: Placebo v Induction: 300 mg Mirikizumab Q8W
    Number of subjects included in analysis
    100
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [12]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    3.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 6.21
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.19
    Notes
    [12] - Physical Component Summary

    Secondary: Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104

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    End point title
    		 Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline through Week 104
    End point description
    Pharmacokinetics (PK): Area Under the Curve (AUC) of Mirikizumab From Baseline Through Week 104. Analysis Population Description: All participants who received at least one dose of study drug and had evaluable PK data. The geometric coefficient of variation presented is "%" and not "±". Due to system limitation, the system populates data field with "±".
    End point type
    Secondary
    End point timeframe
    Week 0, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 52, Week 56, Week 64, Week 72, Week 80, Week 88, Week 96, Week 100, Week 104
    End point values
    		 30 mg mirikizumab Q8W To 30 mg mirikizumab PRN 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN Placebo to 300 mg Mirikizumab Q8W 30 mg mirikizumab Q8W to 300 mg mirikizumab Q8W 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W 300 mg mirikizumab SC Q8W To 300 mg mirikizumab SC Q8W
    Number of subjects analysed
    13
    23
    33
    50
    34
    21
    15
    Units: nanogram*hour per milliliter (ng*hr/mL)
        geometric mean (geometric coefficient of variation)
    3.22 ± 46.33
    8.94 ± 79.19
    22.96 ± 55.80
    46.4 ± 62.8
    34.83 ± 92.13
    47.66 ± 70.08
    51.30 ± 43.54
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up To 120 Weeks
    Adverse event reporting additional description
    All participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Induction: Placebo
    Reporting group description
    		 Induction: Participants received placebo SC Q8W during Induction period.

    Reporting group title
    Induction: 30 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 30 mg mirikizumab Q8W during Induction period.

    Reporting group title
    Induction:100 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 100 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Induction: 300 mg Mirikizumab Q8W
    Reporting group description
    		 Induction: Participants received 300 mg mirikizumab SC Q8W during Induction period.

    Reporting group title
    Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 30 mg mirikizumab as needed (PRN) during the maintenance period. Participants who had ≥ PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 100 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.

    Reporting group title
    Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab as needed (PRN) during the maintenance period. Participants had ≥ PASI 90 at Week 16 after receiving 300 mg mirikizumab Q8W during induction period.

    Reporting group title
    Maintenance: Placebo to 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had received placebo during induction period.

    Reporting group title
    Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 30 mg mirikizumab Q8W during induction period.

    Reporting group title
    Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W
    Reporting group description
    		 Maintenance: Participants received 300 mg mirikizumab Q8W during the maintenance period. Participants had < PASI 90 at Week 16 after receiving 100 mg mirikizumab Q8W during induction period.

    Reporting group title
    Maintenance: 300 mg Mirikizumab Q8W
    Reporting group description
    		 Maintenance: Participants who had < PASI 90 at Week 16 continued to receive 300 mg mirikizumab SC Q8W during maintenance period.

    Reporting group title
    300 mg Mirikizumab Q8W-Rescue
    Reporting group description
    		 Participants received 300 mg Q8W mirikizumab during rescue.

    Reporting group title
    30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up
    Reporting group description
    		 Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up
    Reporting group description
    		 Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up
    Reporting group description
    		 Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    Placebo to 300 mg Mirikizumab Q8W-Follow-up
    Reporting group description
    		 Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
    Reporting group description
    		 Follow-up: Participants did not receive drug during the follow-up period.

    Reporting group title
    100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
    Reporting group description
    		 100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up.

    Serious adverse events
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN Maintenance: Placebo to 300 mg Mirikizumab Q8W Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W Maintenance: 300 mg Mirikizumab Q8W 300 mg Mirikizumab Q8W-Rescue 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up Placebo to 300 mg Mirikizumab Q8W-Follow-up 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up 100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 15 (6.67%)
    2 / 30 (6.67%)
    1 / 34 (2.94%)
    2 / 50 (4.00%)
    2 / 34 (5.88%)
    2 / 21 (9.52%)
    3 / 15 (20.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    colon cancer
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    intraocular melanoma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung neoplasm malignant
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    femur fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    nasal septal operation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    non-cardiac chest pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    enlarged uvula
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    suicidal ideation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    endocarditis bacterial
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis acute
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Induction: Placebo Induction: 30 mg Mirikizumab Q8W Induction:100 mg Mirikizumab Q8W Induction: 300 mg Mirikizumab Q8W Maintenance: 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN Maintenance: 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN Maintenance: 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN Maintenance: Placebo to 300 mg Mirikizumab Q8W Maintenance: 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W Maintenance: 100 mg Mirikizumab Q8W to 300 mg MirikizumabQ8W Maintenance: 300 mg Mirikizumab Q8W 300 mg Mirikizumab Q8W-Rescue 30 mg Mirikizumab Q8W to 30 mg Mirikizumab PRN-Follow-up 100 mg Mirikizumab Q8W to 100 mg Mirikizumab PRN-Follow-up 300 mg Mirikizumab Q8W to 300 mg Mirikizumab PRN-Follow-up Placebo to 300 mg Mirikizumab Q8W-Follow-up 30 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up 100 mg Mirikizumab Q8W to 300 mg Mirikizumab Q8W-Follow-up
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 52 (36.54%)
    24 / 51 (47.06%)
    19 / 51 (37.25%)
    19 / 51 (37.25%)
    13 / 15 (86.67%)
    20 / 30 (66.67%)
    23 / 34 (67.65%)
    38 / 50 (76.00%)
    28 / 34 (82.35%)
    18 / 21 (85.71%)
    13 / 15 (86.67%)
    9 / 10 (90.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    2 / 6 (33.33%)
    1 / 2 (50.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    skin papilloma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    1 / 4 (25.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    1
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    0 / 15 (0.00%)
    3 / 30 (10.00%)
    3 / 34 (8.82%)
    4 / 50 (8.00%)
    3 / 34 (8.82%)
    5 / 21 (23.81%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    3
    3
    0
    3
    4
    4
    3
    5
    1
    0
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    cataract operation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    sinus operation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth extraction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    1 / 34 (2.94%)
    4 / 50 (8.00%)
    3 / 34 (8.82%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
    2 / 10 (20.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    15
    14
    9
    9
    6
    3
    92
    67
    31
    0
    39
    0
    0
    0
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    0 / 34 (0.00%)
    2 / 21 (9.52%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    4
    0
    0
    0
    6
    0
    4
    1
    0
    0
    0
    0
    0
    0
    0
    pyrexia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    2 / 34 (5.88%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [1]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    menorrhagia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [2]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ovarian cyst
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [3]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    prostatomegaly
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [4]
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 11 (0.00%)
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    0 / 40 (0.00%)
    0 / 26 (0.00%)
    0 / 15 (0.00%)
    1 / 9 (11.11%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    scrotal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [5]
    0 / 42 (0.00%)
    0 / 39 (0.00%)
    0 / 35 (0.00%)
    0 / 36 (0.00%)
    0 / 11 (0.00%)
    0 / 20 (0.00%)
    0 / 26 (0.00%)
    0 / 40 (0.00%)
    0 / 26 (0.00%)
    1 / 15 (6.67%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [6]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [7]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    2 / 30 (6.67%)
    2 / 34 (5.88%)
    0 / 50 (0.00%)
    5 / 34 (14.71%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    2
    2
    0
    8
    1
    1
    0
    0
    0
    0
    0
    0
    0
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    2 / 15 (13.33%)
    1 / 30 (3.33%)
    1 / 34 (2.94%)
    3 / 50 (6.00%)
    2 / 34 (5.88%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    1
    1
    3
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    sinus congestion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    2 / 34 (5.88%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    upper respiratory tract congestion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    anxiety
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    2 / 34 (5.88%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    2
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    5
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    2 / 34 (5.88%)
    3 / 21 (14.29%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    5
    5
    0
    0
    0
    0
    0
    0
    0
    0
    electrocardiogram qt prolonged
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    weight increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    facial bones fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    humerus fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    limb injury
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    3 / 50 (6.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    maternal exposure during pregnancy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [8]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
    0 / 4 (0.00%)
    1 / 10 (10.00%)
    0 / 8 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle strain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    2 / 34 (5.88%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    2
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    procedural pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    rib fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    skin laceration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    2 / 50 (4.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    tooth fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    3 / 34 (8.82%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    4
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    myocardial infarction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    headache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
    1 / 15 (6.67%)
    2 / 30 (6.67%)
    3 / 34 (8.82%)
    3 / 50 (6.00%)
    2 / 34 (5.88%)
    2 / 21 (9.52%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    2
    1
    1
    5
    3
    4
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    1
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    abdominal tenderness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    3 / 51 (5.88%)
    2 / 15 (13.33%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    2 / 50 (4.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    1
    3
    2
    0
    1
    2
    1
    0
    3
    0
    0
    0
    0
    0
    0
    0
    duodenal ulcer
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    irritable bowel syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    large intestine polyp
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    2 / 34 (5.88%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    1
    2
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    periodontal disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    toothache
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    hyperplastic cholecystopathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    dermatitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    onycholysis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    3 / 50 (6.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    psoriasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    stasis dermatitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    urticaria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    haematuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    2 / 34 (5.88%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pollakiuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    proteinuria
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    3 / 34 (8.82%)
    1 / 50 (2.00%)
    2 / 34 (5.88%)
    3 / 21 (14.29%)
    1 / 15 (6.67%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    3
    4
    2
    4
    1
    1
    0
    0
    0
    0
    0
    0
    arthritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    3 / 50 (6.00%)
    8 / 34 (23.53%)
    3 / 21 (14.29%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    0
    1
    1
    0
    3
    10
    4
    0
    0
    0
    0
    0
    0
    0
    0
    exostosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    joint swelling
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    2 / 34 (5.88%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle spasms
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    muscle tightness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    2 / 34 (5.88%)
    1 / 50 (2.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    2
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    2 / 21 (9.52%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    psoriatic arthropathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    tenosynovitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    body tinea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    3 / 34 (8.82%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    bronchitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    2 / 21 (9.52%)
    3 / 15 (20.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    1
    0
    0
    1
    2
    4
    0
    0
    0
    0
    0
    0
    0
    conjunctivitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    erythema migrans
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    gastroenteritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    1 / 34 (2.94%)
    3 / 21 (14.29%)
    1 / 15 (6.67%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    3
    1
    1
    0
    0
    0
    0
    0
    0
    gastrointestinal infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    helicobacter infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatitis a
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatitis e
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    2 / 34 (5.88%)
    3 / 50 (6.00%)
    2 / 34 (5.88%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    2
    3
    2
    1
    1
    0
    0
    0
    0
    0
    0
    1
    localised infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    7 / 52 (13.46%)
    5 / 51 (9.80%)
    6 / 51 (11.76%)
    8 / 51 (15.69%)
    3 / 15 (20.00%)
    3 / 30 (10.00%)
    7 / 34 (20.59%)
    15 / 50 (30.00%)
    12 / 34 (35.29%)
    5 / 21 (23.81%)
    5 / 15 (33.33%)
    2 / 10 (20.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    8
    7
    8
    10
    8
    3
    10
    26
    25
    13
    12
    3
    0
    0
    0
    0
    0
    0
    oral herpes
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    2 / 50 (4.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    otitis externa
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    pharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    2 / 50 (4.00%)
    3 / 34 (8.82%)
    3 / 21 (14.29%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    3
    0
    1
    1
    1
    0
    2
    3
    3
    2
    0
    0
    0
    0
    0
    0
    0
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    pulpitis dental
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    1 / 30 (3.33%)
    1 / 34 (2.94%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    tinea pedis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    2 / 34 (5.88%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 52 (3.85%)
    6 / 51 (11.76%)
    3 / 51 (5.88%)
    2 / 51 (3.92%)
    2 / 15 (13.33%)
    5 / 30 (16.67%)
    2 / 34 (5.88%)
    8 / 50 (16.00%)
    3 / 34 (8.82%)
    5 / 21 (23.81%)
    1 / 15 (6.67%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    2
    6
    3
    3
    2
    6
    2
    9
    7
    6
    2
    1
    0
    0
    0
    0
    0
    0
    urethritis chlamydial
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    3 / 34 (8.82%)
    4 / 50 (8.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    2 / 15 (13.33%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    5
    1
    2
    3
    0
    0
    0
    0
    0
    0
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [9]
    0 / 10 (0.00%)
    0 / 12 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
    0 / 4 (0.00%)
    0 / 10 (0.00%)
    1 / 8 (12.50%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    wound infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    diabetes mellitus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    1 / 30 (3.33%)
    2 / 34 (5.88%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    1 / 34 (2.94%)
    1 / 21 (4.76%)
    0 / 15 (0.00%)
    1 / 10 (10.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    1 / 15 (6.67%)
    0 / 30 (0.00%)
    0 / 34 (0.00%)
    1 / 50 (2.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    obesity
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    0 / 30 (0.00%)
    1 / 34 (2.94%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    1 / 15 (6.67%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
    0 / 15 (0.00%)
    2 / 30 (6.67%)
    0 / 34 (0.00%)
    0 / 50 (0.00%)
    0 / 34 (0.00%)
    0 / 21 (0.00%)
    0 / 15 (0.00%)
    0 / 10 (0.00%)
    0 / 2 (0.00%)
    0 / 4 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    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 for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [5] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [7] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [8] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [9] - 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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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