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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled 24-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients with Active Psoriatic Arthritis

    Summary
    EudraCT number
    		 2011-002328-42
    Trial protocol
    		 CZ   DE   ES   IT   GB  
    Global end of trial date
    26 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Jul 2020
    First version publication date
    05 Jul 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I1F-MC-RHBE
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02349295
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 14310
    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
    26 Jun 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 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 how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.
    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
    31 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 20
    Country: Number of subjects enrolled
    United States: 188
    Country: Number of subjects enrolled
    Taiwan: 19
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    United Kingdom: 16
    Country: Number of subjects enrolled
    Australia: 7
    Country: Number of subjects enrolled
    France: 17
    Country: Number of subjects enrolled
    Germany: 36
    Country: Number of subjects enrolled
    Spain: 45
    Worldwide total number of subjects
    363
    EEA total number of subjects
    149
    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)
    301
    From 65 to 84 years
    61
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Not applicable

    Pre-assignment
    Screening details
    		 Not applicable

    Period 1
    Period 1 title
    Double Blind Treatment (Week 0-24)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period
    Arm description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.

    Arm title
    		 Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period
    Arm description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.

    Arm title
    		 Placebo (PBO) - Blinded Treatment Period
    Arm description
    		 Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
    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
    Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.

    Number of subjects in period 1
    		Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Placebo (PBO) - Blinded Treatment Period
    Started
    123
    122
    118
    Received Atleast One Dose of Study Drug
    123
    122
    118
    Completed
    109
    111
    94
    Not completed
    14
    11
    24
         Consent withdrawn by subject
    2
    2
    7
         Adverse event, non-fatal
    7
    5
    5
         Failure To Meet Randomization
    -
    1
    1
         Lost to follow-up
    1
    1
    2
         Lack of efficacy
    4
    2
    9
    Period 2
    Period 2 title
    IR (Week 16-24)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ixe 80 mg Q2W - Blinded Treatment Period IR
    Arm description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.

    Arm title
    		 Ixe 80 mg Q4W - Blinded Treatment Period IR
    Arm description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.

    Arm title
    		 PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR
    Arm description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.

    Arm title
    		 PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
    Arm description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.

    Number of subjects in period 2 [1]
    		Ixe 80 mg Q2W - Blinded Treatment Period IR Ixe 80 mg Q4W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
    Started
    17
    15
    16
    16
    Completed
    16
    15
    16
    16
    Not completed
    1
    0
    0
    0
         Lack of efficacy
    1
    -
    -
    -
    Notes
    [1] - 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: Only IR participants were included.
    Period 3
    Period 3 title
    Long-Term Extension Period (Week 24-156)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period
    Arm description
    		 Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.

    Arm title
    		 Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period
    Arm description
    		 Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.

    Arm title
    		 Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
    Arm description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.

    Arm title
    		 Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Arm description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ixekizumab
    Investigational medicinal product code
    LY2439821
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.

    Number of subjects in period 3
    		Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Started
    107
    111
    46
    46
    Completed
    55
    70
    20
    23
    Not completed
    52
    41
    26
    23
         Adverse event, serious fatal
    1
    1
    1
    -
         Unknown/Missing
    2
    -
    3
    -
         Consent withdrawn by subject
    4
    2
    1
    3
         Physician decision
    2
    2
    -
    -
         Adverse event, non-fatal
    9
    9
    2
    2
         Lost to follow-up
    2
    2
    -
    -
         Lack of efficacy
    32
    25
    19
    18
    Period 4
    Period 4 title
    Follow-Up Period (Up to 12-24 Weeks)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Ixe 80 mg Q2W - Post Treatment Follow-Up Period
    Arm description
    		 Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Ixe 80 mg Q4W - Post Treatment Follow-Up Period
    Arm description
    		 Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 PBO - Post Treatment Follow-Up Period
    Arm description
    		 Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 4
    		Ixe 80 mg Q2W - Post Treatment Follow-Up Period Ixe 80 mg Q4W - Post Treatment Follow-Up Period PBO - Post Treatment Follow-Up Period
    Started
    142
    145
    17
    Completed
    133
    137
    16
    Not completed
    9
    8
    1
         Consent withdrawn by subject
    1
    5
    1
         Physician decision
    2
    -
    -
         Unknown/Missing
    4
    -
    -
         Adverse event, non-fatal
    1
    1
    -
         Lost to follow-up
    1
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.

    Reporting group title
    Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.

    Reporting group title
    Placebo (PBO) - Blinded Treatment Period
    Reporting group description
    		 Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.

    Reporting group values
    		 Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Placebo (PBO) - Blinded Treatment Period Total
    Number of subjects
    		 123 122 118 363
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.7 ± 11.85 52.6 ± 13.57 51.5 ± 10.39 -
    Gender categorical
    Units: Subjects
        Female
    		 73 59 62 194
        Male
    		 50 63 56 169
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 13 11 11 35
        Not Hispanic or Latino
    		 109 109 106 324
        Unknown or Not Reported
    		 1 2 1 4
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 7 7 7 21
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        Black or African American
    		 1 1 1 3
        White
    		 113 111 108 332
        More than one race
    		 1 2 2 5
        Unknown or Not Reported
    		 1 0 0 1
    Region of Enrollment
    Units: Subjects
        Czechia
    		 8 4 8 20
        United States
    		 63 65 60 188
        Taiwan
    		 7 6 6 19
        Poland
    		 5 4 5 14
        Italy
    		 1 0 0 1
        United Kingdom
    		 5 6 5 16
        Australia
    		 3 2 2 7
        France
    		 5 6 6 17
        Germany
    		 12 13 11 36
        Spain
    		 14 16 15 45

    End points

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    End points reporting groups
    Reporting group title
    Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.

    Reporting group title
    Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.

    Reporting group title
    Placebo (PBO) - Blinded Treatment Period
    Reporting group description
    		 Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
    Reporting group title
    Ixe 80 mg Q2W - Blinded Treatment Period IR
    Reporting group description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.

    Reporting group title
    Ixe 80 mg Q4W - Blinded Treatment Period IR
    Reporting group description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.

    Reporting group title
    PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR
    Reporting group description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.

    Reporting group title
    PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
    Reporting group description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
    Reporting group title
    Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.

    Reporting group title
    Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.

    Reporting group title
    Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.

    Reporting group title
    Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
    Reporting group title
    Ixe 80 mg Q2W - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Reporting group title
    Ixe 80 mg Q4W - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Reporting group title
    PBO - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Subject analysis set title
    placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22

    Subject analysis set title
    ixekizumab 80 mg Q4W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22

    Subject analysis set title
    ixekizumab 80 mg Q2W
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22

    Primary: Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
    End point description
    ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP). Analysis population description (APD) included all randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Primary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Percentage of Participants
        number (not applicable)
    19.5
    53.3
    48.0
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    placebo v ixekizumab 80 mg Q4W
    Number of subjects included in analysis
    240
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001 [1]
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    4.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.65
         upper limit
    		 8.48
    Notes
    [1] - model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)
    Comparison groups
    placebo v ixekizumab 80 mg Q2W
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 < 0.001
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    3.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.12
         upper limit
    		 6.78
    Notes
    [2] - model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)

    Secondary: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

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    End point title
    		 Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
    End point description
    HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities.The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do covering the 8 domains.HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region,TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118 [3]
    122 [4]
    123 [5]
    Units: units on a scale
        least squares mean (standard error)
    -0.2 ± 0.08
    -0.6 ± 0.07
    -0.4 ± 0.07
    Notes
    [3] - APD included all randomized participants.
    [4] - APD included all randomized participants.
    [5] - APD included all randomized participants.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ACR20

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    End point title
    		 Percentage of Participants Achieving ACR20
    End point description
    ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Percentage of Participants
        number (not applicable)
    22.0
    50.0
    48.0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
    End point description
    ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Percentage of Participants
        number (not applicable)
    5.1
    35.2
    33.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)

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    End point title
    		 Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
    End point description
    ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Percentage of Participants
        number (not applicable)
    0
    22.1
    12.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Psoriasis Area and Severity Index (PASI) 75

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    End point title
    		 Percentage of Participants with Psoriasis Area and Severity Index (PASI) 75
    End point description
    The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures. APD included all randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    67
    68
    68
    Units: Percentage of Participants
        number (not applicable)
    10.4
    57.4
    61.8
    No statistical analyses for this end point

    Secondary: Percentage of patients achieving Minimal disease activity (MDA)

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    End point title
    		 Percentage of patients achieving Minimal disease activity (MDA)
    End point description
    It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients’ disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1. APD included all randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Percentage of Participants
        number (not applicable)
    3.4
    27.9
    23.6
    No statistical analyses for this end point

    Secondary: Percentage of patients achieving complete resolution in enthesitis as assessed by the Leeds Enthesitis Index (LEI)

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    End point title
    		 Percentage of patients achieving complete resolution in enthesitis as assessed by the Leeds Enthesitis Index (LEI)
    End point description
    The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0” indicates good score here. APD included all randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    69
    68
    84
    Units: Percentage of Participants
        number (not applicable)
    21.7
    35.3
    31.0
    No statistical analyses for this end point

    Secondary: Change from Baseline in Itch Numeric Rating Scale (NRS)

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    End point title
    		 Change from Baseline in Itch Numeric Rating Scale (NRS)
    End point description
    The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -0.7 ± 0.40
    -3.4 ± 0.39
    -3.3 ± 0.39
    No statistical analyses for this end point

    Secondary: Change from Baseline in Tender Joint Count (TJC)

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    End point title
    		 Change from Baseline in Tender Joint Count (TJC)
    End point description
    TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline TJC data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Tender Joint Count
        least squares mean (standard error)
    -6.2 ± 1.96
    -12.7 ± 1.87
    -12.5 ± 1.77
    No statistical analyses for this end point

    Secondary: Change from Baseline in Swollen Joint Count (SJC)

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    End point title
    		 Change from Baseline in Swollen Joint Count (SJC)
    End point description
    SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline SJC data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Swollen Joint Count
        least squares mean (standard error)
    -5.0 ± 1.05
    -8.5 ± 0.99
    -7.4 ± 0.94
    No statistical analyses for this end point

    Secondary: Change from Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)

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    End point title
    		 Change from Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
    End point description
    The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline TJC and SJC data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -21.4 ± 3.97
    -36.9 ± 3.74
    -33.5 ± 3.58
    No statistical analyses for this end point

    Secondary: Change from Baseline in Patients Global Assessment of Disease Activity VAS

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    End point title
    		 Change from Baseline in Patients Global Assessment of Disease Activity VAS
    End point description
    The patient’s overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -19.0 ± 3.91
    -40.7 ± 3.68
    -37.3 ± 3.53
    No statistical analyses for this end point

    Secondary: Change from Baseline in Physicians Global Assessment of Disease Activity VAS

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    End point title
    		 Change from Baseline in Physicians Global Assessment of Disease Activity VAS
    End point description
    The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -18.3 ± 3.98
    -40.0 ± 3.85
    -37.9 ± 3.75
    No statistical analyses for this end point

    Secondary: Change from Baseline in C-Reactive Protein (CRP)

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    End point title
    		 Change from Baseline in C-Reactive Protein (CRP)
    End point description
    C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants with baseline and post baseline CRP data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: milligram per liter (mg/L)
        least squares mean (standard error)
    -3.6 ± 1.87
    -11.8 ± 1.76
    -9.8 ± 1.68
    No statistical analyses for this end point

    Secondary: Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)

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    End point title
    		 Change from Baseline in Disease Activity Score-CRP (DAS28-CRP)
    End point description
    The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118 [6]
    122 [7]
    123 [8]
    Units: Units on a Scale
        least squares mean (standard error)
    -0.8 ± 0.20
    -2.1 ± 0.19
    -1.8 ± 0.18
    Notes
    [6] - APD included all randomized participants who had baseline and post baseline DAS28-CRP data.
    [7] - APD included all randomized participants who had baseline and post baseline DAS28-CRP data.
    [8] - APD included all randomized participants who had baseline and post baseline DAS28-CRP data.
    No statistical analyses for this end point

    Secondary: Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score

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    End point title
    		 Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
    End point description
    The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -2.1 ± 0.38
    -3.7 ± 0.36
    -3.6 ± 0.35
    No statistical analyses for this end point

    Secondary: Change from Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score

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    End point title
    		 Change from Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
    End point description
    The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing “no fatigue” and 10 representing “as bad as you can imagine.” Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants who had baseline and post baseline fatigue NRS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    -0.7 ± 0.37
    -2.0 ± 0.35
    -2.1 ± 0.34
    No statistical analyses for this end point

    Secondary: Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)

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    End point title
    		 Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
    End point description
    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants who had baseline and post baseline PCS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    3.3 ± 1.36
    8.9 ± 1.29
    8.2 ± 1.23
    No statistical analyses for this end point

    Secondary: Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)

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    End point title
    		 Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
    End point description
    The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction. APD included all randomized participants who had baseline and post baseline MCS data.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    118
    122
    123
    Units: Units on a Scale
        least squares mean (standard error)
    0.9 ± 1.32
    3.6 ± 1.24
    4.0 ± 1.18
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)

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    End point title
    		 Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
    End point description
    Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group. APD included all randomized participants who received at least 1 dose of ixekizumab and had evaluable anti-ixekizumab antibody measurement.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 placebo ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    112
    117
    120
    Units: Participants
        number (not applicable)
    1
    8
    4
    No statistical analyses for this end point

    Secondary: Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab

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    End point title
    		 Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
    End point description
    The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported. APD included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
    End point type
    Secondary
    End point timeframe
    All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
    End point values
    		 ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    102
    101
    Units: micograms per milliliter (mcg/mL)
        geometric mean (geometric coefficient of variation)
    2.46 ± 79.1
    7.96 ± 71.1
    No statistical analyses for this end point

    Secondary: Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab

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    End point title
    		 Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
    End point description
    The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively). APD included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
    End point type
    Secondary
    End point timeframe
    All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
    End point values
    		 ixekizumab 80 mg Q4W ixekizumab 80 mg Q2W
    Number of subjects analysed
    105
    100
    Units: mcg*day/mL
        geometric mean (geometric coefficient of variation)
    141 ± 59.3
    143 ± 57.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ACR 20

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    End point title
    		 Percentage of Participants Achieving ACR 20
    End point description
    ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
    End point type
    Secondary
    End point timeframe
    Week 52 and Week 156
    End point values
    		 Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Number of subjects analysed
    107
    111
    46
    46
    Units: Percentage of participants
    number (not applicable)
        Week 52
    58.9
    67.6
    50.0
    60.9
        Week 156
    42.1
    50.5
    39.1
    45.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ACR 50

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    End point title
    		 Percentage of Participants Achieving ACR 50
    End point description
    ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
    End point type
    Secondary
    End point timeframe
    Week 52 and Week 156
    End point values
    		 Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Number of subjects analysed
    107
    111
    46
    46
    Units: Percentage of participants
    number (not applicable)
        Week 52
    38.3
    45.9
    34.8
    43.5
        Week 156
    29.0
    35.1
    26.1
    34.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving ACR 70

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    End point title
    		 Percentage of Participants Achieving ACR 70
    End point description
    ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP. APD included all randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
    End point type
    Secondary
    End point timeframe
    Week 52 and Week 156
    End point values
    		 Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Number of subjects analysed
    107
    111
    46
    46
    Units: Percentage of participants
    number (not applicable)
        Week 52
    20.6
    28.8
    15.2
    23.9
        Week 156
    22.4
    21.6
    10.9
    19.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline Up To 2.55 Years
    Adverse event reporting additional description
    All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.

    Reporting group title
    Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period
    Reporting group description
    		 Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.

    Reporting group title
    Placebo (PBO) - Blinded Treatment Period
    Reporting group description
    		 Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.

    Reporting group title
    Ixe 80 mg Q2W - Blinded Treatment Period IR
    Reporting group description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.

    Reporting group title
    Ixe 80 mg Q4W - Blinded Treatment Period IR
    Reporting group description
    		 Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.

    Reporting group title
    PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR
    Reporting group description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.

    Reporting group title
    PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
    Reporting group description
    		 Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.

    Reporting group title
    Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to ixekizumab 80 mg Q2W at week 0 and continued on ixekizumab 80 mg Q2W during the Extension Period.

    Reporting group title
    Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.

    Reporting group title
    Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.

    Reporting group title
    Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
    Reporting group description
    		 Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period. Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24. Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.

    Reporting group title
    Ixe 80 mg Q2W - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Reporting group title
    Ixe 80 mg Q4W - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Reporting group title
    PBO - Post Treatment Follow-Up Period
    Reporting group description
    		 Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).

    Serious adverse events
    		 Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Placebo (PBO) - Blinded Treatment Period Ixe 80 mg Q2W - Blinded Treatment Period IR Ixe 80 mg Q4W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Ixe 80 mg Q2W - Post Treatment Follow-Up Period Ixe 80 mg Q4W - Post Treatment Follow-Up Period PBO - Post Treatment Follow-Up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 123 (6.50%)
    3 / 122 (2.46%)
    4 / 118 (3.39%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    10 / 107 (9.35%)
    13 / 111 (11.71%)
    6 / 46 (13.04%)
    3 / 46 (6.52%)
    1 / 142 (0.70%)
    2 / 145 (1.38%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    1
    1
    1
    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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    gastrointestinal stromal tumour
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    malignant melanoma in situ
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    metastatic renal cell carcinoma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         deaths 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
    papillary thyroid cancer
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    prostate cancer
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [1]
    0 / 50 (0.00%)
    1 / 63 (1.59%)
    0 / 56 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    0 / 46 (0.00%)
    0 / 56 (0.00%)
    0 / 22 (0.00%)
    0 / 20 (0.00%)
    0 / 64 (0.00%)
    0 / 72 (0.00%)
    0 / 9 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Vascular disorders
    peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Surgical and medical procedures
    coronary arterial stent insertion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    1 / 145 (0.69%)
    0 / 17 (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 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    knee arthroplasty
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Pregnancy, puerperium and perinatal conditions
    abortion spontaneous
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [2]
    1 / 73 (1.37%)
    0 / 59 (0.00%)
    0 / 62 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 61 (0.00%)
    0 / 55 (0.00%)
    0 / 22 (0.00%)
    0 / 26 (0.00%)
    0 / 78 (0.00%)
    0 / 73 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Reproductive system and breast disorders
    adnexa uteri cyst
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [3]
    0 / 73 (0.00%)
    0 / 59 (0.00%)
    1 / 62 (1.61%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 61 (0.00%)
    0 / 55 (0.00%)
    0 / 22 (0.00%)
    0 / 26 (0.00%)
    0 / 78 (0.00%)
    0 / 73 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    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
    uterine prolapse
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [4]
    1 / 73 (1.37%)
    0 / 59 (0.00%)
    0 / 62 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 61 (0.00%)
    0 / 55 (0.00%)
    0 / 22 (0.00%)
    0 / 26 (0.00%)
    0 / 78 (0.00%)
    0 / 73 (0.00%)
    0 / 8 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    bronchospasm
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    dyspnoea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    Investigations
    hepatic enzyme increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    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
    Injury, poisoning and procedural complications
    ankle fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    fall
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    femoral neck fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    foot fracture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    postoperative wound complication
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tendon rupture
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Cardiac disorders
    acute coronary syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    acute myocardial infarction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    cardio-respiratory arrest
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery thrombosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    myocardial infarction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial ischaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    1 / 142 (0.70%)
    0 / 145 (0.00%)
    0 / 17 (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 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebrovascular accident
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemorrhagic stroke
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Blood and lymphatic system disorders
    iron deficiency anaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Ear and labyrinth disorders
    vertigo
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Eye disorders
    retinal detachment
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    anal fistula
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    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
         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
    colitis ischaemic
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    colitis ulcerative
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    inguinal hernia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    nausea
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    vomiting
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    hepatic cirrhosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    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
    Skin and subcutaneous tissue disorders
    psoriasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    basedow's disease
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    Musculoskeletal and connective tissue disorders
    myofascial pain syndrome
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    psoriatic arthropathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    1 / 145 (0.69%)
    0 / 17 (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 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    abscess jaw
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    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
         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
    anal abscess
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    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
         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
    diverticulitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    latent tuberculosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    lower respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    oesophageal candidiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    oral candidiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    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
    osteomyelitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (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
         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
    perirectal abscess
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    pneumonia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    postoperative wound infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    diabetes mellitus
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    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
         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
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The gender specific events only occurring in male or female participants were adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The gender specific events only occurring in male or female participants were adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The gender specific events only occurring in male or female participants were adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The gender specific events only occurring in male or female participants were adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ixekizumab 80 mg Q2W (Ixe 80 mg Q2W)- Blinded Treatment Period Ixekizumab 80 mg Q4W (Ixe 80 mg Q4W)- Blinded Treatment Period Placebo (PBO) - Blinded Treatment Period Ixe 80 mg Q2W - Blinded Treatment Period IR Ixe 80 mg Q4W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR Ixe 80 mg Q2W / Ixe 80 mg Q2W - Extended Treatment Period Ixe 80 mg Q4W / Ixe 80 mg Q4W - Extended Treatment Period Placebo/ Ixe 80 mg Q2W - Extended Treatment Period Placebo/ Ixe 80 mg Q4W - Extended Treatment Period Ixe 80 mg Q2W - Post Treatment Follow-Up Period Ixe 80 mg Q4W - Post Treatment Follow-Up Period PBO - Post Treatment Follow-Up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    58 / 123 (47.15%)
    58 / 122 (47.54%)
    40 / 118 (33.90%)
    5 / 17 (29.41%)
    8 / 15 (53.33%)
    11 / 16 (68.75%)
    8 / 16 (50.00%)
    59 / 107 (55.14%)
    65 / 111 (58.56%)
    20 / 46 (43.48%)
    32 / 46 (69.57%)
    16 / 142 (11.27%)
    13 / 145 (8.97%)
    2 / 17 (11.76%)
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    6 / 123 (4.88%)
    2 / 122 (1.64%)
    3 / 118 (2.54%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    3 / 107 (2.80%)
    3 / 111 (2.70%)
    1 / 46 (2.17%)
    3 / 46 (6.52%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    6
    3
    3
    0
    0
    0
    0
    3
    3
    1
    3
    0
    0
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    influenza like illness
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    1
    0
    4
    0
    0
    0
    injection site erythema
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 123 (3.25%)
    3 / 122 (2.46%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    20
    4
    0
    2
    0
    2
    0
    11
    0
    0
    0
    0
    0
    0
    injection site induration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 122 (0.82%)
    2 / 118 (1.69%)
    2 / 17 (11.76%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    3 / 107 (2.80%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    6
    1
    4
    4
    0
    3
    0
    7
    0
    1
    1
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    15 / 123 (12.20%)
    6 / 122 (4.92%)
    1 / 118 (0.85%)
    2 / 17 (11.76%)
    1 / 15 (6.67%)
    2 / 16 (12.50%)
    1 / 16 (6.25%)
    6 / 107 (5.61%)
    2 / 111 (1.80%)
    4 / 46 (8.70%)
    5 / 46 (10.87%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    47
    20
    1
    3
    2
    2
    2
    92
    39
    7
    5
    0
    0
    0
    injection site swelling
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    3 / 107 (2.80%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    15
    1
    0
    0
    0
    0
    2
    46
    1
    0
    15
    0
    0
    0
    Reproductive system and breast disorders
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [5]
    1 / 50 (2.00%)
    0 / 63 (0.00%)
    0 / 56 (0.00%)
    0 / 5 (0.00%)
    0 / 9 (0.00%)
    0 / 10 (0.00%)
    0 / 9 (0.00%)
    1 / 46 (2.17%)
    1 / 56 (1.79%)
    1 / 24 (4.17%)
    3 / 20 (15.00%)
    0 / 64 (0.00%)
    0 / 72 (0.00%)
    0 / 9 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    3
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    cough
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 123 (3.25%)
    4 / 122 (3.28%)
    3 / 118 (2.54%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    4 / 107 (3.74%)
    6 / 111 (5.41%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    1 / 142 (0.70%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    5
    5
    3
    0
    0
    1
    0
    4
    6
    0
    1
    1
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    7 / 122 (5.74%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 107 (1.87%)
    2 / 111 (1.80%)
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    7
    0
    0
    0
    0
    0
    2
    3
    1
    1
    0
    0
    0
    Psychiatric disorders
    sleep terror
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 123 (1.63%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    2 / 107 (1.87%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    1 / 145 (0.69%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    1
    2
    1
    0
    0
    0
    1
    0
    blood bilirubin increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    4 / 111 (3.60%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    1 / 142 (0.70%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    1
    4
    1
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    exposure to toxic agent
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    lymphadenopathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    2 / 107 (1.87%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    2
    0
    0
    1
    0
    0
    0
    thrombocytopenia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    0
    0
    0
    Eye disorders
    entropion
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    dental caries
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    2 / 107 (1.87%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    2
    2
    2
    0
    0
    0
    0
    0
    gastritis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    4 / 46 (8.70%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    5
    0
    0
    0
    haemorrhoids
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    2 / 107 (1.87%)
    1 / 111 (0.90%)
    1 / 46 (2.17%)
    3 / 46 (6.52%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    2
    1
    1
    3
    0
    0
    0
    mouth ulceration
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    rectal haemorrhage
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    3 / 46 (6.52%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    Hepatobiliary disorders
    hepatic steatosis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    1 / 107 (0.93%)
    3 / 111 (2.70%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    1
    3
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    alopecia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 123 (2.44%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    3 / 111 (2.70%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    0
    0
    1
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    erythema
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    3 / 122 (2.46%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    night sweats
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus generalised
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    1 / 118 (0.85%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    1 / 111 (0.90%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Endocrine disorders
    goitre
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    back pain
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    5 / 122 (4.10%)
    2 / 118 (1.69%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    5 / 107 (4.67%)
    8 / 111 (7.21%)
    0 / 46 (0.00%)
    3 / 46 (6.52%)
    1 / 142 (0.70%)
    1 / 145 (0.69%)
    0 / 17 (0.00%)
         occurrences all number
    1
    5
    2
    0
    0
    1
    0
    5
    9
    0
    3
    1
    1
    0
    muscle spasms
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    0 / 122 (0.00%)
    2 / 118 (1.69%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    3 / 111 (2.70%)
    3 / 46 (6.52%)
    0 / 46 (0.00%)
    1 / 142 (0.70%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    1
    3
    3
    0
    1
    0
    0
    psoriatic arthropathy
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 123 (2.44%)
    3 / 122 (2.46%)
    8 / 118 (6.78%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    3 / 107 (2.80%)
    1 / 111 (0.90%)
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    1 / 142 (0.70%)
    6 / 145 (4.14%)
    0 / 17 (0.00%)
         occurrences all number
    3
    3
    8
    0
    0
    0
    0
    6
    1
    1
    4
    1
    6
    0
    Infections and infestations
    bronchitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    3 / 123 (2.44%)
    1 / 122 (0.82%)
    4 / 118 (3.39%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    11 / 107 (10.28%)
    11 / 111 (9.91%)
    1 / 46 (2.17%)
    2 / 46 (4.35%)
    1 / 142 (0.70%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    3
    2
    4
    0
    0
    0
    1
    12
    13
    1
    4
    1
    0
    0
    cystitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    1 / 17 (5.88%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    2 / 111 (1.80%)
    0 / 46 (0.00%)
    2 / 46 (4.35%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    3
    0
    2
    0
    0
    0
    ear infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    0 / 122 (0.00%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    1 / 111 (0.90%)
    1 / 46 (2.17%)
    1 / 46 (2.17%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    1
    1
    3
    3
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    1 / 123 (0.81%)
    2 / 122 (1.64%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    4 / 107 (3.74%)
    2 / 111 (1.80%)
    3 / 46 (6.52%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    2
    2
    0
    0
    0
    0
    4
    2
    3
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 123 (3.25%)
    9 / 122 (7.38%)
    4 / 118 (3.39%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    15 / 107 (14.02%)
    20 / 111 (18.02%)
    6 / 46 (13.04%)
    4 / 46 (8.70%)
    3 / 142 (2.11%)
    5 / 145 (3.45%)
    0 / 17 (0.00%)
         occurrences all number
    4
    11
    4
    0
    1
    0
    0
    26
    32
    11
    6
    4
    5
    0
    otitis externa
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    2 / 122 (1.64%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    2 / 107 (1.87%)
    0 / 111 (0.00%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    otitis media
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    2 / 123 (1.63%)
    1 / 122 (0.82%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    1 / 15 (6.67%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 107 (0.93%)
    5 / 111 (4.50%)
    0 / 46 (0.00%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    1
    1
    0
    1
    0
    0
    1
    6
    0
    0
    0
    0
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    2 / 122 (1.64%)
    1 / 118 (0.85%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    3 / 46 (6.52%)
    1 / 142 (0.70%)
    1 / 145 (0.69%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    0
    1
    3
    1
    1
    0
    sinusitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    5 / 123 (4.07%)
    7 / 122 (5.74%)
    2 / 118 (1.69%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    10 / 107 (9.35%)
    11 / 111 (9.91%)
    4 / 46 (8.70%)
    6 / 46 (13.04%)
    3 / 142 (2.11%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    7
    7
    2
    0
    0
    0
    1
    14
    13
    4
    6
    3
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    4 / 122 (3.28%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    3 / 107 (2.80%)
    4 / 111 (3.60%)
    1 / 46 (2.17%)
    2 / 46 (4.35%)
    0 / 142 (0.00%)
    1 / 145 (0.69%)
    0 / 17 (0.00%)
         occurrences all number
    0
    4
    0
    0
    0
    1
    0
    3
    4
    1
    3
    0
    1
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    12 / 123 (9.76%)
    12 / 122 (9.84%)
    9 / 118 (7.63%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    20 / 107 (18.69%)
    15 / 111 (13.51%)
    4 / 46 (8.70%)
    8 / 46 (17.39%)
    2 / 142 (1.41%)
    1 / 145 (0.69%)
    0 / 17 (0.00%)
         occurrences all number
    12
    14
    12
    0
    0
    1
    0
    33
    23
    7
    9
    2
    1
    0
    urinary tract infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    4 / 123 (3.25%)
    6 / 122 (4.92%)
    3 / 118 (2.54%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    6 / 107 (5.61%)
    7 / 111 (6.31%)
    1 / 46 (2.17%)
    5 / 46 (10.87%)
    2 / 142 (1.41%)
    0 / 145 (0.00%)
    2 / 17 (11.76%)
         occurrences all number
    4
    11
    3
    0
    0
    0
    0
    13
    8
    1
    9
    3
    0
    2
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [6]
    2 / 73 (2.74%)
    0 / 59 (0.00%)
    0 / 62 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    0 / 61 (0.00%)
    1 / 55 (1.82%)
    0 / 22 (0.00%)
    1 / 26 (3.85%)
    0 / 78 (0.00%)
    0 / 73 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    0
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed [7]
    2 / 73 (2.74%)
    1 / 59 (1.69%)
    1 / 62 (1.61%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 7 (0.00%)
    2 / 61 (3.28%)
    0 / 55 (0.00%)
    0 / 22 (0.00%)
    2 / 26 (7.69%)
    0 / 78 (0.00%)
    0 / 73 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    0
    2
    0
    0
    2
    0
    0
    0
    Metabolism and nutrition disorders
    hyperuricaemia
    alternative dictionary used: MedDRA 22.0
         subjects affected / exposed
    0 / 123 (0.00%)
    1 / 122 (0.82%)
    0 / 118 (0.00%)
    0 / 17 (0.00%)
    0 / 15 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 107 (0.00%)
    0 / 111 (0.00%)
    1 / 46 (2.17%)
    0 / 46 (0.00%)
    0 / 142 (0.00%)
    0 / 145 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Notes
    [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: The gender specific events only occurring in male or female participants were 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: The gender specific events only occurring in male or female participants were 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: The gender specific events only occurring in male or female participants were 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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