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    Clinical Trial Results:
    A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients with Axial Spondyloarthritis

    Summary
    EudraCT number
    2016-002634-69
    Trial protocol
    ES   HU   NL   FI   PL   AT   DE   IT  
    Global end of trial date
    27 May 2021

    Results information
    Results version number
    v2(current)
    This version publication date
    28 May 2022
    First version publication date
    10 Jun 2021
    Other versions
    v1
    Version creation reason
    • New data added to full data set
    LPV Results

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    I1F-MC-RHBY
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03129100
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Trial Number: 16181
    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
    27 May 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.
    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
    09 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 34
    Country: Number of subjects enrolled
    Romania: 5
    Country: Number of subjects enrolled
    Hungary: 7
    Country: Number of subjects enrolled
    United States: 61
    Country: Number of subjects enrolled
    Czechia: 88
    Country: Number of subjects enrolled
    Japan: 22
    Country: Number of subjects enrolled
    United Kingdom: 12
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Russian Federation: 66
    Country: Number of subjects enrolled
    Canada: 11
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 81
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    Taiwan: 44
    Country: Number of subjects enrolled
    Finland: 9
    Country: Number of subjects enrolled
    Brazil: 23
    Country: Number of subjects enrolled
    Poland: 160
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Mexico: 104
    Country: Number of subjects enrolled
    Israel: 10
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 9
    Worldwide total number of subjects
    773
    EEA total number of subjects
    317
    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)
    737
    From 65 to 84 years
    36
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Lead-In: 24 weeks (Week 0 to 24) Extension Period including Double-Blind, Placebo-Controlled, Randomized Withdrawal-Retreatment (RWR): 40 weeks (Week 24 to 64) Long-Term Extension Period: 40 weeks (Week 64 to 104) Post-Treatment Follow-Up: at least 12 weeks and up to 24 weeks after the date of the participant's ETV or last regularly scheduled.

    Pre-assignment
    Screening details
    In Period 2, participants (pts) who did not achieve sustained remission were assigned to Group A, pts who did achieve sustained remission were assigned to Group B (Randomized Withdrawal Extension(RWE)) and were randomized 2:1 to either IXE or Placebo. pts who experienced a flare in group B were retreated with IXE in Retreatment Extension Period.

    Period 1
    Period 1 title
    Lead-In Period (Period 1)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IXE80Q4W-Lead-in Period
    Arm description
    Participants received 80 milligram (mg) of Ixekizumab (IXE) subcutaneously (SC) every four weeks (Q4W) for up to week 24.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    IXE80Q2W-Lead-in Period
    Arm description
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Number of subjects in period 1
    IXE80Q4W-Lead-in Period IXE80Q2W-Lead-in Period
    Started
    350
    423
    Completed
    335
    406
    Not completed
    15
    17
         Consent withdrawn by subject
    8
    8
         Adverse event, non-fatal
    2
    6
         Lost to follow-up
    2
    -
         Check with team
    -
    1
         Lack of efficacy
    3
    2
    Period 2
    Period 2 title
    Extension Period (Period 2A)
    Is this the baseline period?
    Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    IXE80Q4W-Group A Extension Period
    Arm description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.
    Arm type
    Placebo

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    IXE80Q2W-Group A Extension Period
    Arm description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    IXE80Q4W-Group B-Randomized Withdrawal Extension Period
    Arm description
    Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    IXE80Q2W-Group B-Randomized Withdrawal Extension Period
    Arm description
    Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    Placebo-Group B-Randomized Withdrawal Extension Period
    Arm description
    Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were randomized to receive subcutaneous injection of placebo.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Baseline analysis population is based on efficacy population of all randomized participants (Extension Period).
    Number of subjects in period 2
    IXE80Q4W-Group A Extension Period IXE80Q2W-Group A Extension Period IXE80Q4W-Group B-Randomized Withdrawal Extension Period IXE80Q2W-Group B-Randomized Withdrawal Extension Period Placebo-Group B-Randomized Withdrawal Extension Period
    Started
    255
    318
    48
    54
    53
    Completed
    234
    312
    42
    45
    32
    Not completed
    21
    6
    6
    9
    21
         Adverse event, serious fatal
    1
    -
    -
    -
    -
         Consent withdrawn by subject
    13
    5
    1
    1
    2
         Physician decision
    1
    -
    -
    -
    -
         Adverse event, non-fatal
    2
    1
    -
    2
    -
         Lost to follow-up
    2
    -
    -
    -
    -
         Experienced Flare and retreated
    -
    -
    5
    6
    19
         Lack of efficacy
    2
    -
    -
    -
    -
    Period 3
    Period 3 title
    Retreatment Extension Period (Period 2)
    Is this the baseline period?
    No
    Allocation method
    Non-randomised - controlled
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IXE80Q2W/IXE80Q2W-retreatment Extension Period
    Arm description
    Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    IXE80Q4W/IXE80Q4W-Retreatment Extension Period
    Arm description
    Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    PBO/IXE80Q2W-Retreatment Extension Period
    Arm description
    Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    PBO/IXE80Q4W-Retreatment Extension Period
    Arm description
    Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Number of subjects in period 3
    IXE80Q2W/IXE80Q2W-retreatment Extension Period IXE80Q4W/IXE80Q4W-Retreatment Extension Period PBO/IXE80Q2W-Retreatment Extension Period PBO/IXE80Q4W-Retreatment Extension Period
    Started
    6
    5
    9
    10
    Completed
    6
    5
    8
    10
    Not completed
    0
    0
    1
    0
         Consent withdrawn by subject
    -
    -
    1
    -
    Period 4
    Period 4 title
    Period3-Long-Term Extension Period A & B
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    IXE80Q2W-group A Long-term Extension Period
    Arm description
    Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    IXE80Q4W-group A Long-term Extension Period
    Arm description
    Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    IXE80Q2W-randomized Withdrawal Long-term Extension Period
    Arm description
    Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    IXE80Q4W-randomized Withdrawal Long-term Extension Period
    Arm description
    Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    PBO-randomized Withdrawal Long-term Extension Period
    Arm description
    Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
    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 were randomized to receive subcutaneous injection of placebo.

    Number of subjects in period 4
    IXE80Q2W-group A Long-term Extension Period IXE80Q4W-group A Long-term Extension Period IXE80Q2W-randomized Withdrawal Long-term Extension Period IXE80Q4W-randomized Withdrawal Long-term Extension Period PBO-randomized Withdrawal Long-term Extension Period
    Started
    306
    177
    45
    42
    30
    Completed
    287
    146
    40
    37
    21
    Not completed
    19
    31
    5
    5
    9
         Consent withdrawn by subject
    12
    7
    4
    2
    -
         Adverse event, non-fatal
    6
    -
    -
    -
    -
         Lost to follow-up
    1
    -
    1
    1
    -
         Escalated to IXE80Q2W
    -
    24
    -
    2
    8
         Lack of efficacy
    -
    -
    -
    -
    1
    Period 5
    Period 5 title
    Period 3 (Flare)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    IXE80Q2W/IXE80Q2W-retreatment Long-term Extension Period
    Arm description
    Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    IXE80Q4W/IXE80Q4W-retreatment Long-term Extension Period
    Arm description
    Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    PBO/IXE80Q2W-retreatment Long-term Extension Period
    Arm description
    Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q2W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks.

    Arm title
    PBO/IXE80Q4W-retreatment Long-term Extension Period
    Arm description
    Participants in Group B who experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Number of subjects in period 5
    IXE80Q2W/IXE80Q2W-retreatment Long-term Extension Period IXE80Q4W/IXE80Q4W-retreatment Long-term Extension Period PBO/IXE80Q2W-retreatment Long-term Extension Period PBO/IXE80Q4W-retreatment Long-term Extension Period
    Started
    6
    4
    11
    15
    Completed
    6
    2
    11
    12
    Not completed
    0
    2
    0
    3
         Escalated to IXE80Q2W
    -
    2
    -
    3
    Period 6
    Period 6 title
    Period 3 (Dose Escalation)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    IXE80Q4W-group A Escalation Period
    Arm description
    Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    IXE80Q4W-randomized Withdrawal Escalation Period
    Arm description
    Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    IXE80Q4W
    Investigational medicinal product code
    Other name
    Ixekizumab; LY2439821
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 80 mg of Ixekizumab subcutaneously every four weeks.

    Arm title
    PBO-randomized Withdrawal Escalation Period
    Arm description
    Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
    Arm type
    Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants were randomized to receive subcutaneous injection of placebo.

    Number of subjects in period 6
    IXE80Q4W-group A Escalation Period IXE80Q4W-randomized Withdrawal Escalation Period PBO-randomized Withdrawal Escalation Period
    Started
    77
    5
    4
    Completed
    73
    5
    4
    Not completed
    4
    0
    0
         Consent withdrawn by subject
    2
    -
    -
         Physician decision
    1
    -
    -
         Lack of efficacy
    1
    -
    -
    Period 7
    Period 7 title
    Period 4 (Post Treatment Follow-up)
    Is this the baseline period?
    No
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    PBO-follow-up Period
    Arm description
    Participants did not receive any intervention during Follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    IXE80Q4W-follow-up Period
    Arm description
    Participants did not receive any intervention during Follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    IXE80Q2W-follow-up Period
    Arm description
    Participants did not receive any intervention during Follow-up period.
    Arm type
    No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 7
    PBO-follow-up Period IXE80Q4W-follow-up Period IXE80Q2W-follow-up Period
    Started
    25
    223
    453
    Completed
    22
    198
    411
    Not completed
    3
    25
    42
         Adverse event, serious fatal
    -
    1
    -
         Consent withdrawn by subject
    3
    20
    37
         COVID 19 restrictions
    -
    2
    -
         Unknown
    -
    -
    2
         Missed to follow-up
    -
    -
    1
         Lost to follow-up
    -
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    IXE80Q4W-Group A Extension Period
    Reporting group description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.

    Reporting group title
    IXE80Q2W-Group A Extension Period
    Reporting group description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.

    Reporting group title
    IXE80Q4W-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.

    Reporting group title
    IXE80Q2W-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.

    Reporting group title
    Placebo-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics presented only for treatment group.
    Reporting group values
    IXE80Q4W-Group A Extension Period IXE80Q2W-Group A Extension Period IXE80Q4W-Group B-Randomized Withdrawal Extension Period IXE80Q2W-Group B-Randomized Withdrawal Extension Period Placebo-Group B-Randomized Withdrawal Extension Period Total
    Number of subjects
    255 318 48 54 53 728
    Age categorical
    Units: Subjects
        <=18 years
    0 0 0 0 0 0
        Between 18 and 65 years
    240 302 48 53 52 695
        >=65 years
    15 16 0 1 1 33
    Gender categorical
    Units: Subjects
        Female
    68 95 10 14 15 202
        Male
    187 223 38 40 38 526
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    61 86 7 14 11 179
        Not Hispanic or Latino
    166 204 31 35 39 475
        Unknown or Not Reported
    28 28 10 5 3 74
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    14 11 2 5 4 36
        Asian
    54 50 15 15 13 147
        Native Hawaiian or Other Pacific Islander
    0 0 0 0 0 0
        Black or African American
    0 2 0 0 0 2
        White
    183 247 31 31 35 527
        More than one race
    3 8 0 3 1 15
        Unknown or Not Reported
    1 0 0 0 0 1
    Region of Enrollment
    Units: Subjects
        Argentina
    11 18 1 1 2 33
        Romania
    1 3 0 1 0 5
        Hungary
    3 2 1 1 0 7
        United States
    14 30 1 3 2 50
        Czechia
    37 35 5 4 4 85
        Japan
    7 9 1 3 1 21
        United Kingdom
    4 6 0 1 0 11
        Spain
    5 4 0 1 0 10
        Russia
    16 30 6 7 6 65
        Canada
    3 2 1 0 2 8
        Netherlands
    0 2 0 0 0 2
        South Korea
    28 23 10 7 8 76
        Austria
    1 1 0 1 0 3
        Taiwan
    17 16 3 5 2 43
        Finland
    0 5 0 1 2 8
        Brazil
    7 16 0 0 0 23
        Poland
    50 67 13 7 13 150
        Italy
    0 1 0 0 0 1
        Mexico
    40 38 5 11 8 102
        Israel
    5 3 0 0 1 9
        France
    4 4 0 0 0 8
        Germany
    2 3 1 0 2 8

    End points

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    End points reporting groups
    Reporting group title
    IXE80Q4W-Lead-in Period
    Reporting group description
    Participants received 80 milligram (mg) of Ixekizumab (IXE) subcutaneously (SC) every four weeks (Q4W) for up to week 24.

    Reporting group title
    IXE80Q2W-Lead-in Period
    Reporting group description
    Participants received 80 mg of Ixekizumab subcutaneously every two weeks (Q2W) for up to week 24.
    Reporting group title
    IXE80Q4W-Group A Extension Period
    Reporting group description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q4W subcutaneous dose during the extension period.

    Reporting group title
    IXE80Q2W-Group A Extension Period
    Reporting group description
    Participants continued to receive uninterrupted Ixekizumab 80 mg Q2W subcutaneous dose during the extension period.

    Reporting group title
    IXE80Q4W-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants in the Ixekizumab 80 mg Q4W treatment group (Lead-in) were re randomized to receive Ixekizumab 80 mg Q4W subcutaneous dose at Week 24 in the randomized withdrawal extension period.

    Reporting group title
    IXE80Q2W-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants in the Ixekizumab 80 mg Q2W treatment group (Lead-in) were re randomized to receive subcutaneous dose of Ixekizumab 80 mg Q2W at Week 24 in the randomized withdrawal extension period.

    Reporting group title
    Placebo-Group B-Randomized Withdrawal Extension Period
    Reporting group description
    Participants were re-randomized to receive subcutaneous dose of placebo at Week 24 in the randomized withdrawal extension period.
    Reporting group title
    IXE80Q2W/IXE80Q2W-retreatment Extension Period
    Reporting group description
    Participants in Group B who received Ixekizumab 80 mg Q2W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.

    Reporting group title
    IXE80Q4W/IXE80Q4W-Retreatment Extension Period
    Reporting group description
    Participants in Group B who received Ixekizumab 80 mg Q4W in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.

    Reporting group title
    PBO/IXE80Q2W-Retreatment Extension Period
    Reporting group description
    Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.

    Reporting group title
    PBO/IXE80Q4W-Retreatment Extension Period
    Reporting group description
    Participants in Group B who received placebo in Period 2 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Reporting group title
    IXE80Q2W-group A Long-term Extension Period
    Reporting group description
    Participants from "IXE80Q2W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.

    Reporting group title
    IXE80Q4W-group A Long-term Extension Period
    Reporting group description
    Participants from "IXE80Q4W group A extension period" continued to receive same treatment that they were receiving at the end of Period 2.

    Reporting group title
    IXE80Q2W-randomized Withdrawal Long-term Extension Period
    Reporting group description
    Participants from "IXE80Q2W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.

    Reporting group title
    IXE80Q4W-randomized Withdrawal Long-term Extension Period
    Reporting group description
    Participants from "IXE80Q4W-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.

    Reporting group title
    PBO-randomized Withdrawal Long-term Extension Period
    Reporting group description
    Participants from "Placebo-Group B-Randomized Withdrawal Extension Period" continued to receive same treatment that they were receiving at the end of Period 2.
    Reporting group title
    IXE80Q2W/IXE80Q2W-retreatment Long-term Extension Period
    Reporting group description
    Participants in Group B who received Ixekizumab 80 mg Q2W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long-term extension period.

    Reporting group title
    IXE80Q4W/IXE80Q4W-retreatment Long-term Extension Period
    Reporting group description
    Participants in Group B who received Ixekizumab 80 mg Q4W in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.

    Reporting group title
    PBO/IXE80Q2W-retreatment Long-term Extension Period
    Reporting group description
    Participants in Group B who received placebo in Period 3 and experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q2W during the retreatment long term extension period.

    Reporting group title
    PBO/IXE80Q4W-retreatment Long-term Extension Period
    Reporting group description
    Participants in Group B who experienced a flare were retreated with subcutaneous dose of Ixekizumab 80 mg Q4W during the retreatment long term extension period.
    Reporting group title
    IXE80Q4W-group A Escalation Period
    Reporting group description
    Participants in Group A receiving ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W in Period 3.

    Reporting group title
    IXE80Q4W-randomized Withdrawal Escalation Period
    Reporting group description
    Participants in Group B receiving Ixekizumab 80 mg Q4W escalated to ixekizumab 80 mg Q2W.

    Reporting group title
    PBO-randomized Withdrawal Escalation Period
    Reporting group description
    Participants in Group B, who received PBO, experienced a flare and retreated with Ixekizumab 80 mg Q4W, escalated to ixekizumab 80 mg Q2W.
    Reporting group title
    PBO-follow-up Period
    Reporting group description
    Participants did not receive any intervention during Follow-up period.

    Reporting group title
    IXE80Q4W-follow-up Period
    Reporting group description
    Participants did not receive any intervention during Follow-up period.

    Reporting group title
    IXE80Q2W-follow-up Period
    Reporting group description
    Participants did not receive any intervention during Follow-up period.

    Subject analysis set title
    Combined IXE
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received 80 mg of Ixekizumab subcutaneously (SC) every four weeks (Q4W) and every two weeks (Q2W) during the randomized withdrawal extension period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received placebo subcutaneously during the randomized withdrawal extension period.

    Subject analysis set title
    IXE80Q4W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received 80 mg of Ixekizumab subcutaneously (SC) every four weeks (Q4W) during the randomized withdrawal extension period.

    Subject analysis set title
    IXE80Q2W
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants received 80 mg of Ixekizumab subcutaneously (SC) every two weeks (Q2W) during the randomized withdrawal extension period.

    Primary: Percentage of Participants who do not Experience a Flare (Combined Ixekizumab Treatment)

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    End point title
    Percentage of Participants who do not Experience a Flare (Combined Ixekizumab Treatment)
    End point description
    A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS ≥2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. APD: pts who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR.
    End point type
    Primary
    End point timeframe
    Week 64
    End point values
    Combined IXE Placebo
    Number of subjects analysed
    102
    53
    Units: Percentage of participants
        number (not applicable)
    83.3
    54.7
    Statistical analysis title
    Who do not Experience a Flare (Combined IXE)
    Comparison groups
    Placebo v Combined IXE
    Number of subjects included in analysis
    155
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.35
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.03
         upper limit
    9.35

    Secondary: Percentage of Participants who do not Experience a Flare

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    End point title
    Percentage of Participants who do not Experience a Flare
    End point description
    A flare is defined as ASDAS ≥2.1 at 2 consecutive visits or ASDAS >3.5 at any visit during Period 2. ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1) (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. APD: pts who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using NRI.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of participants
        number (not applicable)
    54.7
    83.3
    83.3
    Statistical analysis title
    Participants Who do Not Experience a Flare
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.66
         upper limit
    11.03
    Statistical analysis title
    Participants Who do Not Experience a Flare
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.77
         upper limit
    11.02

    Secondary: Change from Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)

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    End point title
    Change from Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
    End point description
    The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge. By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 [no change] to 72 [progression]. APD: Ixekizumab structure population who have been treated with ixekizumab for at least 24 months.
    End point type
    Secondary
    End point timeframe
    Baseline, 2 Years (108 Weeks)
    End point values
    Combined IXE IXE80Q4W IXE80Q2W
    Number of subjects analysed
    230
    115
    115
    Units: Units on a Scale
        arithmetic mean (standard deviation)
    0.32 ( 1.779 )
    0.41 ( 2.102 )
    0.23 ( 1.387 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response

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    End point title
    Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
    End point description
    ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit in the remaining domain. Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities, response measured on NRS (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). APD: Participants who achieved a state of sustained remission and randomized to 40-week DBPC RWR period.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of participants
        number (not applicable)
    50.9
    81.3
    81.5
    Statistical analysis title
    ASAS20 response
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.51
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.78
         upper limit
    11.41
    Statistical analysis title
    ASAS20 response
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.88
         upper limit
    11.31

    Secondary: Percentage of Participants Achieving an ASAS40 Response

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    End point title
    Percentage of Participants Achieving an ASAS40 Response
    End point description
    ASAS40 is defined as a ≥40% improvement and an absolute improvement from baseline of ≥2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used: Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). BASFI: Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on mean of BASDAI Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). APD: Participants who achieved a state of sustained remission and were randomized to 40-week DBPLC RWR period.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of Participants
        number (not applicable)
    43.4
    79.2
    79.6
    Statistical analysis title
    ASAS40 Response
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.11
         upper limit
    12.69
    Statistical analysis title
    ASAS40 Response
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.2
         upper limit
    12.47

    Secondary: Percentage of Participants with Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units

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    End point title
    Percentage of Participants with Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
    End point description
    ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness +0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of participants
        number (not applicable)
    45.3
    79.2
    74.1
    Statistical analysis title
    ASDAS ≥1.1 Units
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.9
         upper limit
    11.17
    Statistical analysis title
    ASDAS ≥1.1 Units
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.56
         upper limit
    8.09

    Secondary: Percentage of Participants with Inactive Disease on the ASDAS (<1.3 Units)

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    End point title
    Percentage of Participants with Inactive Disease on the ASDAS (<1.3 Units)
    End point description
    ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness +0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of participants
        number (not applicable)
    24.5
    60.4
    53.7
    Statistical analysis title
    ASDAS (<1.3 Units)
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.07
         upper limit
    11.72
    Statistical analysis title
    ASDAS (<1.3 Units)
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.003
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    3.61
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.57
         upper limit
    8.32

    Secondary: Change from Baseline in the Individual Components of the ASAS Criteria

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    End point title
    Change from Baseline in the Individual Components of the ASAS Criteria
    End point description
    Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active). Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). BASFI: Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of BASDAI (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD:Participants who achieved a state of sustained remission and were randomized to 40-week DBPC RWR. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Units on a scale
    least squares mean (standard error)
        Patient Global
    -3.0 ( 0.36 )
    -5.1 ( 0.38 )
    -5.0 ( 0.36 )
        Spinal Pain
    -3.0 ( 0.36 )
    -5.1 ( 0.39 )
    -4.8 ( 0.37 )
        BASFI
    -2.79 ( 0.301 )
    -4.35 ( 0.316 )
    -4.19 ( 0.301 )
        Inflammation
    -3.03 ( 0.317 )
    -5.20 ( 0.336 )
    -4.83 ( 0.319 )
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Patient Global
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    -1.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51
    Notes
    [1] - Patient Global
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Patient Global
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [2]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.49
    Notes
    [2] - Patient Global
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Spinal Pain
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [3]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.1
         upper limit
    -1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.51
    Notes
    [3] - Spinal Pain
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Spinal Pain
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [4]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    -0.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.49
    Notes
    [4] - Spinal Pain
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    BASFI
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [5]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.39
         upper limit
    -0.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.421
    Notes
    [5] - BASFI
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    BASFI
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [6]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.2
         upper limit
    -0.59
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.409
    Notes
    [6] - BASFI
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Inflammation
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [7]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.17
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.05
         upper limit
    -1.28
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.448
    Notes
    [7] - Inflammation
    Statistical analysis title
    ASAS Criteria
    Statistical analysis description
    Inflammation
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [8]
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.66
         upper limit
    -0.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.433
    Notes
    [8] - Inflammation

    Secondary: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response

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    End point title
    Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
    End point description
    The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the nonresponder imputation (NRI) method.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of participants
        number (not applicable)
    45.3
    81.3
    75.9
    Statistical analysis title
    BASDAI50
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    5.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.13
         upper limit
    13.35
    Statistical analysis title
    BASDAI50
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.001
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.75
         upper limit
    9.45

    Secondary: Change from Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)

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    End point title
    Change from Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
    End point description
    High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: milligram per liter (mg/L)
        least squares mean (standard error)
    -5.094 ( 1.3696 )
    -12.952 ( 1.4666 )
    -11.074 ( 1.3861 )
    Statistical analysis title
    High Sensitivity C-Reactive Protein (CRP)
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.001
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -7.858
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -11.729
         upper limit
    -3.987
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.9586
    Statistical analysis title
    High Sensitivity C-Reactive Protein (CRP)
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.002
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -5.979
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.655
         upper limit
    -2.304
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.86

    Secondary: Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

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    End point title
    Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
    End point description
    BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA). 1) Lateral Spinal Flexion 2) Tragus-to-wall distance 3) Lumbar Flexion (modified Schober) 4) Maximal intermalleolar distance and 5) Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Units on a scale
        least squares mean (standard error)
    -0.50 ( 0.073 )
    -0.69 ( 0.080 )
    -0.73 ( 0.075 )
    Statistical analysis title
    BASMI
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.062
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.4
         upper limit
    0.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.104
    Statistical analysis title
    BASMI
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.018
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.24
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.43
         upper limit
    -0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.099

    Secondary: Change from Baseline in Chest Expansion in Centimeters

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    End point title
    Change from Baseline in Chest Expansion in Centimeters
    End point description
    Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: centimeter (cm)
        least squares mean (standard error)
    0.67 ( 0.236 )
    0.77 ( 0.256 )
    0.53 ( 0.243 )
    Statistical analysis title
    Chest Expansion in Centimeters
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.757
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.56
         upper limit
    0.77
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.335
    Statistical analysis title
    Chest Expansion in Centimeters
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.67
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.77
         upper limit
    0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.322

    Secondary: Change from Baseline in Occiput to Wall Distance

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    End point title
    Change from Baseline in Occiput to Wall Distance
    End point description
    The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: cm
        least squares mean (standard error)
    -0.38 ( 0.235 )
    -0.78 ( 0.260 )
    -0.66 ( 0.239 )
    Statistical analysis title
    Occiput to Wall Distance
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.236
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.07
         upper limit
    0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.338
    Statistical analysis title
    Occiput to Wall Distance
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.373
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.28
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.92
         upper limit
    0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.319

    Secondary: Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

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    End point title
    Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
    End point description
    The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with Baseline MASES score >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    35
    29
    36
    Units: Units on a scale
        least squares mean (standard error)
    -3.48 ( 0.302 )
    -3.55 ( 0.352 )
    -3.62 ( 0.315 )
    Statistical analysis title
    MASES
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    64
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.885
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.98
         upper limit
    0.85
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.459
    Statistical analysis title
    MASES
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    71
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.735
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.95
         upper limit
    0.68
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.41

    Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score

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    End point title
    Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
    End point description
    The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B).
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    30
    22
    30
    Units: Units on a scale
        least squares mean (standard error)
    -2.71 ( 0.335 )
    -3.23 ( 0.388 )
    -3.34 ( 0.338 )
    Statistical analysis title
    SPARCC Enthesitis Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.294
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.53
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.53
         upper limit
    0.47
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.501
    Statistical analysis title
    SPARCC Enthesitis Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    60
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.164
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.54
         upper limit
    0.27
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.453

    Secondary: Change from Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints

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    End point title
    Change from Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints
    End point description
    The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline TJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    23
    27
    33
    Units: Units on a scale
        least squares mean (standard error)
    -4.0 ( 0.85 )
    -6.1 ( 0.76 )
    -5.3 ( 0.74 )
    Statistical analysis title
    TJC Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.063
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -2.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1
    Statistical analysis title
    TJC Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.211
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.3
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    0.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.02

    Secondary: Change from Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints

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    End point title
    Change from Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints
    End point description
    The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and with baseline SJC >0. Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    15
    16
    21
    Units: Units on a scale
        least squares mean (standard error)
    -2.7 ( 0.73 )
    -3.6 ( 0.67 )
    -3.9 ( 0.59 )
    Statistical analysis title
    SJC Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.334
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.9
    Statistical analysis title
    SJC Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.168
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -1.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3
         upper limit
    0.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.88

    Secondary: Percentage of Participants with Anterior Uveitis or Uveitis Flares

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    End point title
    Percentage of Participants with Anterior Uveitis or Uveitis Flares
    End point description
    Anterior uveitis is an inflammation of the middle layer of the eye, which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B), and regardless of history of anterior uveitis.
    End point type
    Secondary
    End point timeframe
    Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: Percentage of Participants
        number (not applicable)
    5.7
    4.2
    5.6
    No statistical analyses for this end point

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

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    End point title
    Change from Baseline in the Fatigue 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 rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    -3.5 ( 0.28 )
    -4.2 ( 0.31 )
    -4.3 ( 0.29 )
    Statistical analysis title
    NRS Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    0.1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.4
    Statistical analysis title
    NRS Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.047
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    0
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.38

    Secondary: Change from Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)

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    End point title
    Change from Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)
    End point description
    The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    -2.80 ( 0.342 )
    -3.68 ( 0.362 )
    -3.28 ( 0.344 )
    Statistical analysis title
    QIDS-SR16
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.068
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.83
         upper limit
    0.06
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.479
    Statistical analysis title
    QIDS-SR16
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.307
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    0.44
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.465

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

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    End point title
    Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
    End point description
    The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    10.6934 ( 1.0366 )
    13.2954 ( 1.1210 )
    13.1030 ( 1.0457 )
    Statistical analysis title
    Physical Component Summary (PCS) Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.079
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.6021
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3011
         upper limit
    5.5053
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.4684
    Statistical analysis title
    Physical Component Summary (PCS) Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.087
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.4096
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.3541
         upper limit
    5.1734
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.3978

    Secondary: Change from Baseline in SF-36 Mental Component Summary (MCS) Score

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    End point title
    Change from Baseline in SF-36 Mental Component Summary (MCS) Score
    End point description
    The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    2.3396 ( 0.8314 )
    3.1766 ( 0.8968 )
    4.6404 ( 0.8369 )
    Statistical analysis title
    Mental Component Summary (MCS) Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.477
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.837
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4864
         upper limit
    3.1605
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1752
    Statistical analysis title
    Mental Component Summary (MCS) Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.042
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    2.3009
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.088
         upper limit
    4.5138
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.1192

    Secondary: Change from Baseline in ASAS Health Index (ASAS HI)

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    End point title
    Change from Baseline in ASAS Health Index (ASAS HI)
    End point description
    The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the patient needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the modified baseline observation carried forward (mBOCF) method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    -3.64 ( 0.370 )
    -4.64 ( 0.393 )
    -4.37 ( 0.368 )
    Statistical analysis title
    ASAS HI
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.058
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.02
         upper limit
    0.04
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.52
    Statistical analysis title
    ASAS HI
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.147
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.71
         upper limit
    0.26
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.497

    Secondary: Change from Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK population-based index score

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    End point title
    Change from Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK population-based index score
    End point description
    The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent’s health and a rating of his/her current health state using a 0- to 100-mm visual analog scale (VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using the mBOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    0.2459 ( 0.0237 )
    0.2877 ( 0.0252 )
    0.2847 ( 0.0235 )
    Statistical analysis title
    EQ-5D-5L UK Population-based Index Score
    Comparison groups
    Placebo v IXE80Q4W
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.213
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.0418
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0329
         upper limit
    0.1164
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0334
    Statistical analysis title
    EQ-5D-5L UK Population-based Index Score
    Comparison groups
    Placebo v IXE80Q2W
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.225
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    0.0388
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0324
         upper limit
    0.1101
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.0319

    Secondary: Change from Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores

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    End point title
    Change from Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
    End point description
    The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using MBOCF.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
    least squares mean (standard error)
        Overall Work Impairment Score
    -28.73 ( 3.677 )
    -40.94 ( 3.752 )
    -36.53 ( 3.221 )
        Percentage of Activity Impairment
    -32.96 ( 3.099 )
    -43.58 ( 3.329 )
    -40.10 ( 3.115 )
    Statistical analysis title
    WPAI-SpA Scores
    Statistical analysis description
    Overall Work Impairment Score
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [9]
    P-value
    = 0.016
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -12.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.04
         upper limit
    -2.38
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.939
    Notes
    [9] - Overall Work Impairment Score
    Statistical analysis title
    WPAI-SpA Scores
    Statistical analysis description
    Overall Work Impairment Score
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [10]
    P-value
    = 0.092
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -7.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -16.91
         upper limit
    1.31
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.578
    Notes
    [10] - Overall Work Impairment Score
    Statistical analysis title
    WPAI-SpA Scores
    Statistical analysis description
    Percentage of Activity Impairment
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority [11]
    P-value
    = 0.017
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -10.62
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -19.28
         upper limit
    -1.95
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.383
    Notes
    [11] - Percentage of Activity Impairment
    Statistical analysis title
    WPAI-SpA Scores
    Statistical analysis description
    Percentage of Activity Impairment
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority [12]
    P-value
    = 0.091
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -7.14
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -15.44
         upper limit
    1.16
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.199
    Notes
    [12] - Percentage of Activity Impairment

    Secondary: Change from Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)

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    End point title
    Change from Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
    End point description
    JSEQ is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. APD: Participants who achieved a state of sustained remission and were randomized to 40-week double-blind placebo controlled RWR period (Group B). Missing data was imputed using mBOCF method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    53
    48
    54
    Units: units on a scale
        least squares mean (standard error)
    -3.6 ( 0.47 )
    -4.0 ( 0.50 )
    -3.8 ( 0.47 )
    Statistical analysis title
    JSEQ
    Comparison groups
    IXE80Q4W v Placebo
    Number of subjects included in analysis
    101
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.531
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    0.9
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.66
    Statistical analysis title
    JSEQ
    Comparison groups
    IXE80Q2W v Placebo
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.743
    Method
    ANCOVA
    Parameter type
    LS Mean Difference
    Point estimate
    -0.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -1.4
         upper limit
    1
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.62

    Secondary: Percentage of Participants with No New Syndesmophyte Formation

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    End point title
    Percentage of Participants with No New Syndesmophyte Formation
    End point description
    Percentage of participants with no new syndesmophyte formation was measured using the average score of 2 selected readers of 3 readers. APD: Ixekizumab structure population who have been treated with Ixekizumab for at least 24 months
    End point type
    Secondary
    End point timeframe
    Week 56
    End point values
    IXE80Q4W IXE80Q2W
    Number of subjects analysed
    115
    115
    Units: Percentage of participants
        number (not applicable)
    80.9
    87.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-Ixekizumab Antibodies

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    End point title
    Percentage of Participants with Anti-Ixekizumab Antibodies
    End point description
    A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%. APD: All randomized participants from Group B, who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 64
    End point values
    Placebo IXE80Q4W IXE80Q2W
    Number of subjects analysed
    45
    43
    51
    Units: Percentage of participants
        number (not applicable)
    4.7
    2.0
    20.0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline, up to 128 weeks
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    IXE80Q2W-lead-in period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-lead-in period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-randomized withdrawal extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W-randomized withdrawal extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-group A extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W-group A extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W/IXE80Q2W-retreatment extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W/IXE80Q4W-retreatment extension period
    Reporting group description
    -

    Reporting group title
    PBO-randomized withdrawal extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-group A long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO/IXE80Q2W-retreatment extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W-group A long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO/IXE80Q4W-retreatment extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W-randomized withdrawal long-term extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-randomized withdrawal long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO-randomized withdrawal long-term extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W/IXE80Q4W-retreatment long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO/IXE80Q2W-retreatment long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO/IXE80Q4W-retreatment long-term extension period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W/IXE80Q2W-retreatment long-term extension period
    Reporting group description
    -

    Reporting group title
    PBO-randomized withdrawal escalation period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-randomized withdrawal escalation period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-group A escalation period
    Reporting group description
    -

    Reporting group title
    PBO-follow-up period
    Reporting group description
    -

    Reporting group title
    IXE80Q4W-follow-up period
    Reporting group description
    -

    Reporting group title
    IXE80Q2W-follow-up period
    Reporting group description
    -

    Serious adverse events
    IXE80Q2W-lead-in period IXE80Q4W-lead-in period IXE80Q4W-randomized withdrawal extension period IXE80Q2W-randomized withdrawal extension period IXE80Q4W-group A extension period IXE80Q2W-group A extension period IXE80Q2W/IXE80Q2W-retreatment extension period IXE80Q4W/IXE80Q4W-retreatment extension period PBO-randomized withdrawal extension period IXE80Q4W-group A long-term extension period PBO/IXE80Q2W-retreatment extension period IXE80Q2W-group A long-term extension period PBO/IXE80Q4W-retreatment extension period IXE80Q2W-randomized withdrawal long-term extension period IXE80Q4W-randomized withdrawal long-term extension period PBO-randomized withdrawal long-term extension period IXE80Q4W/IXE80Q4W-retreatment long-term extension period PBO/IXE80Q2W-retreatment long-term extension period PBO/IXE80Q4W-retreatment long-term extension period IXE80Q2W/IXE80Q2W-retreatment long-term extension period PBO-randomized withdrawal escalation period IXE80Q4W-randomized withdrawal escalation period IXE80Q4W-group A escalation period PBO-follow-up period IXE80Q4W-follow-up period IXE80Q2W-follow-up period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 423 (2.84%)
    10 / 348 (2.87%)
    2 / 47 (4.26%)
    2 / 54 (3.70%)
    12 / 255 (4.71%)
    11 / 318 (3.46%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    1 / 53 (1.89%)
    3 / 177 (1.69%)
    0 / 9 (0.00%)
    15 / 306 (4.90%)
    0 / 10 (0.00%)
    1 / 45 (2.22%)
    1 / 42 (2.38%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 77 (1.30%)
    0 / 25 (0.00%)
    3 / 223 (1.35%)
    2 / 453 (0.44%)
         number of deaths (all causes)
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
         number of deaths resulting from adverse events
    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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    abdominal neoplasm
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    adenocarcinoma
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    anal cancer
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    benign lung neoplasm
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    breast cancer
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic lymphocytic leukaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian cancer
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [1]
    1 / 130 (0.77%)
    0 / 92 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 68 (0.00%)
    0 / 95 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 91 (0.00%)
    0 / 2 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 57 (0.00%)
    0 / 136 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [2]
    0 / 130 (0.00%)
    0 / 92 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 68 (0.00%)
    0 / 95 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 91 (0.00%)
    0 / 2 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 57 (0.00%)
    0 / 136 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    papillary thyroid cancer
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    venous thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    venous thrombosis limb
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    death
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    soft tissue inflammation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 53 (1.89%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    dysmenorrhoea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [3]
    0 / 130 (0.00%)
    0 / 92 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 68 (0.00%)
    0 / 95 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    1 / 91 (1.10%)
    0 / 2 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 57 (0.00%)
    0 / 136 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    haemothorax
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    depression
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    major depression
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    suicidal ideation
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    clavicle fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    comminuted fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    1 / 177 (0.56%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    compression fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    1 / 47 (2.13%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    concussion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    contusion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    femur fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ilium fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ligament sprain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    limb injury
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lumbar vertebral fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumothorax traumatic
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    rib fracture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal column injury
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    synovial rupture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    1 / 45 (2.22%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    cardiac failure acute
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery stenosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    1 / 177 (0.56%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myocardial infarction
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    1 / 177 (0.56%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 77 (1.30%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 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 / 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
    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 ischaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    1 / 453 (0.22%)
         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
    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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral venous sinus thrombosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hypoglycaemic unconsciousness
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    myelopathy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    radiculopathy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    neutropenia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (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 / 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
    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
    iridocyclitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    colitis ulcerative
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 423 (0.47%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    2 / 255 (0.78%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    2 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    crohn's disease
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (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 / 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
    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 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    1 / 177 (0.56%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    strangulated umbilical hernia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis acute
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    subcutaneous emphysema
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urticaria
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    calculus urinary
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    nephrolithiasis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    renal colic
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ureterolithiasis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary incontinence
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    1 / 453 (0.22%)
         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 / 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
    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
    arthritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    axial spondyloarthritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    back pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    2 / 348 (0.57%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    2 / 255 (0.78%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pseudarthrosis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    spinal ligament ossification
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    temporomandibular joint syndrome
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tenosynovitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    3 / 306 (0.98%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    1 / 3
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (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 / 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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    chronic tonsillitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    clostridium difficile colitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    influenza
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    1 / 6 (16.67%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    orchitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [4]
    0 / 293 (0.00%)
    1 / 256 (0.39%)
    0 / 37 (0.00%)
    0 / 40 (0.00%)
    0 / 187 (0.00%)
    0 / 223 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 38 (0.00%)
    0 / 130 (0.00%)
    0 / 7 (0.00%)
    0 / 215 (0.00%)
    0 / 8 (0.00%)
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 21 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 12 (0.00%)
    0 / 4 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 56 (0.00%)
    0 / 17 (0.00%)
    0 / 166 (0.00%)
    0 / 317 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    respiratory tract infection viral
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sepsis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    urinary tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hyperglycaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (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
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hyperkalaemia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    IXE80Q2W-lead-in period IXE80Q4W-lead-in period IXE80Q4W-randomized withdrawal extension period IXE80Q2W-randomized withdrawal extension period IXE80Q4W-group A extension period IXE80Q2W-group A extension period IXE80Q2W/IXE80Q2W-retreatment extension period IXE80Q4W/IXE80Q4W-retreatment extension period PBO-randomized withdrawal extension period IXE80Q4W-group A long-term extension period PBO/IXE80Q2W-retreatment extension period IXE80Q2W-group A long-term extension period PBO/IXE80Q4W-retreatment extension period IXE80Q2W-randomized withdrawal long-term extension period IXE80Q4W-randomized withdrawal long-term extension period PBO-randomized withdrawal long-term extension period IXE80Q4W/IXE80Q4W-retreatment long-term extension period PBO/IXE80Q2W-retreatment long-term extension period PBO/IXE80Q4W-retreatment long-term extension period IXE80Q2W/IXE80Q2W-retreatment long-term extension period PBO-randomized withdrawal escalation period IXE80Q4W-randomized withdrawal escalation period IXE80Q4W-group A escalation period PBO-follow-up period IXE80Q4W-follow-up period IXE80Q2W-follow-up period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    108 / 423 (25.53%)
    79 / 348 (22.70%)
    8 / 47 (17.02%)
    17 / 54 (31.48%)
    62 / 255 (24.31%)
    82 / 318 (25.79%)
    0 / 6 (0.00%)
    4 / 5 (80.00%)
    16 / 53 (30.19%)
    37 / 177 (20.90%)
    2 / 9 (22.22%)
    52 / 306 (16.99%)
    1 / 10 (10.00%)
    8 / 45 (17.78%)
    6 / 42 (14.29%)
    9 / 30 (30.00%)
    3 / 4 (75.00%)
    6 / 11 (54.55%)
    5 / 15 (33.33%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    2 / 5 (40.00%)
    6 / 77 (7.79%)
    0 / 25 (0.00%)
    14 / 223 (6.28%)
    27 / 453 (5.96%)
    Surgical and medical procedures
    keratomileusis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    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
    General disorders and administration site conditions
    fatigue
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 423 (0.71%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    1 / 255 (0.39%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    2 / 306 (0.65%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    1 / 30 (3.33%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    3
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    ovarian cyst
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [5]
    0 / 130 (0.00%)
    0 / 92 (0.00%)
    1 / 10 (10.00%)
    0 / 14 (0.00%)
    0 / 68 (0.00%)
    0 / 95 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
    0 / 47 (0.00%)
    0 / 2 (0.00%)
    0 / 91 (0.00%)
    0 / 2 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 57 (0.00%)
    0 / 136 (0.00%)
         occurrences all number
    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
    Investigations
    neutrophil count decreased
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    0 / 348 (0.00%)
    1 / 47 (2.13%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    1 / 42 (2.38%)
    0 / 30 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    contusion
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    2 / 348 (0.57%)
    1 / 47 (2.13%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 53 (1.89%)
    2 / 177 (1.13%)
    1 / 9 (11.11%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    1
    0
    0
    1
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    foreign body in eye
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tendon rupture
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    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
    Cardiac disorders
    tachycardia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    leukopenia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    2 / 318 (0.63%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    2 / 306 (0.65%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    1 / 453 (0.22%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Eye disorders
    iridocyclitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    5 / 423 (1.18%)
    8 / 348 (2.30%)
    2 / 47 (4.26%)
    2 / 54 (3.70%)
    7 / 255 (2.75%)
    10 / 318 (3.14%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    3 / 53 (5.66%)
    6 / 177 (3.39%)
    0 / 9 (0.00%)
    6 / 306 (1.96%)
    0 / 10 (0.00%)
    2 / 45 (4.44%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    5 / 453 (1.10%)
         occurrences all number
    5
    8
    2
    3
    8
    11
    0
    0
    3
    6
    0
    7
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    6
    Gastrointestinal disorders
    abdominal pain upper
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    2 / 423 (0.47%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    2 / 54 (3.70%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 53 (1.89%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    2 / 30 (6.67%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    2
    1
    0
    2
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    crohn's disease
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    1 / 453 (0.22%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    1
    diarrhoea
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    10 / 423 (2.36%)
    3 / 348 (0.86%)
    0 / 47 (0.00%)
    3 / 54 (5.56%)
    6 / 255 (2.35%)
    5 / 318 (1.57%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    1 / 53 (1.89%)
    2 / 177 (1.13%)
    0 / 9 (0.00%)
    3 / 306 (0.98%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    1 / 453 (0.22%)
         occurrences all number
    10
    4
    0
    3
    6
    6
    0
    0
    1
    2
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    toothache
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    1 / 423 (0.24%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    1 / 255 (0.39%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 77 (1.30%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    1
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    cold urticaria
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    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
    rash
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    5 / 423 (1.18%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    1 / 255 (0.39%)
    3 / 318 (0.94%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    3 / 53 (5.66%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 77 (1.30%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    5
    2
    0
    3
    1
    3
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    urticaria
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    1 / 348 (0.29%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    1 / 255 (0.39%)
    1 / 318 (0.31%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    1 / 15 (6.67%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    0 / 453 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    6 / 423 (1.42%)
    8 / 348 (2.30%)
    0 / 47 (0.00%)
    1 / 54 (1.85%)
    5 / 255 (1.96%)
    14 / 318 (4.40%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    4 / 177 (2.26%)
    0 / 9 (0.00%)
    2 / 306 (0.65%)
    0 / 10 (0.00%)
    1 / 45 (2.22%)
    2 / 42 (4.76%)
    1 / 30 (3.33%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    1 / 77 (1.30%)
    0 / 25 (0.00%)
    1 / 223 (0.45%)
    5 / 453 (1.10%)
         occurrences all number
    6
    9
    0
    1
    7
    16
    0
    0
    0
    4
    0
    4
    0
    1
    2
    1
    0
    1
    0
    0
    0
    0
    1
    0
    1
    6
    back pain
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    15 / 423 (3.55%)
    9 / 348 (2.59%)
    1 / 47 (2.13%)
    3 / 54 (5.56%)
    3 / 255 (1.18%)
    3 / 318 (0.94%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    2 / 53 (3.77%)
    1 / 177 (0.56%)
    1 / 9 (11.11%)
    2 / 306 (0.65%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    2 / 223 (0.90%)
    2 / 453 (0.44%)
         occurrences all number
    15
    9
    1
    3
    3
    3
    0
    1
    2
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    2
    chondrodynia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    1 / 306 (0.33%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    enthesopathy
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    3 / 423 (0.71%)
    3 / 348 (0.86%)
    1 / 47 (2.13%)
    1 / 54 (1.85%)
    1 / 255 (0.39%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    1 / 4 (25.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    3
    3
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    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
    myalgia
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    2 / 348 (0.57%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    2 / 255 (0.78%)
    3 / 318 (0.94%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    2 / 306 (0.65%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    2 / 30 (6.67%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    3
    0
    0
    0
    0
    0
    2
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    covid-19
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    3 / 306 (0.98%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    1 / 30 (3.33%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    3 / 453 (0.66%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    3
    gastrointestinal viral infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    0 / 10 (0.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    40 / 423 (9.46%)
    27 / 348 (7.76%)
    2 / 47 (4.26%)
    4 / 54 (7.41%)
    27 / 255 (10.59%)
    30 / 318 (9.43%)
    0 / 6 (0.00%)
    1 / 5 (20.00%)
    7 / 53 (13.21%)
    17 / 177 (9.60%)
    1 / 9 (11.11%)
    19 / 306 (6.21%)
    0 / 10 (0.00%)
    2 / 45 (4.44%)
    1 / 42 (2.38%)
    3 / 30 (10.00%)
    0 / 4 (0.00%)
    1 / 11 (9.09%)
    2 / 15 (13.33%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    1 / 5 (20.00%)
    2 / 77 (2.60%)
    0 / 25 (0.00%)
    4 / 223 (1.79%)
    6 / 453 (1.32%)
         occurrences all number
    42
    28
    3
    6
    33
    32
    0
    1
    8
    19
    1
    20
    0
    4
    1
    3
    0
    1
    2
    0
    0
    1
    2
    0
    4
    6
    pharyngitis
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    9 / 423 (2.13%)
    5 / 348 (1.44%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    9 / 255 (3.53%)
    7 / 318 (2.20%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    3 / 53 (5.66%)
    3 / 177 (1.69%)
    0 / 9 (0.00%)
    6 / 306 (1.96%)
    0 / 10 (0.00%)
    1 / 45 (2.22%)
    1 / 42 (2.38%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    2 / 453 (0.44%)
         occurrences all number
    10
    6
    0
    0
    9
    7
    0
    0
    3
    3
    0
    7
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    upper respiratory tract infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    22 / 423 (5.20%)
    16 / 348 (4.60%)
    2 / 47 (4.26%)
    4 / 54 (7.41%)
    7 / 255 (2.75%)
    13 / 318 (4.09%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    2 / 53 (3.77%)
    3 / 177 (1.69%)
    1 / 9 (11.11%)
    8 / 306 (2.61%)
    0 / 10 (0.00%)
    2 / 45 (4.44%)
    1 / 42 (2.38%)
    2 / 30 (6.67%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    2 / 77 (2.60%)
    0 / 25 (0.00%)
    2 / 223 (0.90%)
    1 / 453 (0.22%)
         occurrences all number
    24
    19
    3
    4
    7
    14
    0
    0
    2
    3
    1
    10
    0
    2
    1
    2
    0
    0
    0
    0
    0
    0
    2
    0
    2
    1
    vaginal infection
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed [6]
    0 / 130 (0.00%)
    0 / 92 (0.00%)
    0 / 10 (0.00%)
    0 / 14 (0.00%)
    0 / 68 (0.00%)
    0 / 95 (0.00%)
    0 / 2 (0.00%)
    0 / 1 (0.00%)
    0 / 15 (0.00%)
    1 / 47 (2.13%)
    0 / 2 (0.00%)
    0 / 91 (0.00%)
    0 / 2 (0.00%)
    0 / 11 (0.00%)
    0 / 9 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 3 (0.00%)
    0 / 2 (0.00%)
    0 / 21 (0.00%)
    0 / 8 (0.00%)
    0 / 57 (0.00%)
    1 / 136 (0.74%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    glucose tolerance impaired
    alternative dictionary used: MedDRA 24.0
         subjects affected / exposed
    0 / 423 (0.00%)
    0 / 348 (0.00%)
    0 / 47 (0.00%)
    0 / 54 (0.00%)
    0 / 255 (0.00%)
    0 / 318 (0.00%)
    0 / 6 (0.00%)
    0 / 5 (0.00%)
    0 / 53 (0.00%)
    0 / 177 (0.00%)
    0 / 9 (0.00%)
    0 / 306 (0.00%)
    1 / 10 (10.00%)
    0 / 45 (0.00%)
    0 / 42 (0.00%)
    0 / 30 (0.00%)
    0 / 4 (0.00%)
    0 / 11 (0.00%)
    0 / 15 (0.00%)
    0 / 6 (0.00%)
    0 / 4 (0.00%)
    0 / 5 (0.00%)
    0 / 77 (0.00%)
    0 / 25 (0.00%)
    0 / 223 (0.00%)
    0 / 453 (0.00%)
         occurrences all number
    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
    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: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

    More information

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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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