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    Clinical Trial Results:
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Mirikizumab to Secukinumab and Placebo in Patients with Moderate-to-Severe Plaque Psoriasis

    Summary
    EudraCT number
    		 2017-003286-10
    Trial protocol
    		 GB   DE   ES   FR   CZ   HU   PL   IT  
    Global end of trial date
    03 Jun 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Mar 2021
    First version publication date
    19 Mar 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    I6T-MC-AMAJ
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03535194
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Trial Number: 16504
    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
    03 Jun 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Jun 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The reason for this study is to see how effective and safe mirikizumab is compared to secukinumab and placebo for moderate to severe plaque psoriasis.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 87
    Country: Number of subjects enrolled
    Australia: 60
    Country: Number of subjects enrolled
    Canada: 86
    Country: Number of subjects enrolled
    Israel: 46
    Country: Number of subjects enrolled
    Japan: 145
    Country: Number of subjects enrolled
    Korea, Republic of: 55
    Country: Number of subjects enrolled
    Puerto Rico: 36
    Country: Number of subjects enrolled
    United States: 272
    Country: Number of subjects enrolled
    France: 66
    Country: Number of subjects enrolled
    Germany: 179
    Country: Number of subjects enrolled
    Hungary: 86
    Country: Number of subjects enrolled
    Italy: 23
    Country: Number of subjects enrolled
    Poland: 169
    Country: Number of subjects enrolled
    Spain: 73
    Country: Number of subjects enrolled
    Czechia: 95
    Country: Number of subjects enrolled
    United Kingdom: 6
    Worldwide total number of subjects
    1484
    EEA total number of subjects
    691
    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)
    1331
    From 65 to 84 years
    153
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 NA

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250mg Q4W Mirikizumab
    Arm description
    		 Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period.

    Arm title
    		 250mg Q4W Mirikizumab
    Arm description
    		 Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period.

    Arm title
    		 Placebo
    Arm description
    		 Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.

    Arm title
    		 300mg Secukinumab
    Arm description
    		 Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.

    Arm title
    		 Japan GPP/EP
    Arm description
    		 Participants received 250mg Mirikizumab Q4W by SC injection during induction period. A plaque psoriasis participant was misrandomized by the site.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250mg Mirikizumab Q4W by SC injection during induction period.

    Number of subjects in period 1
    		250mg Q4W Mirikizumab 250mg Q4W Mirikizumab Placebo 300mg Secukinumab Japan GPP/EP
    Started
    454
    451
    112
    448
    19
    Received at least one dose of study drug
    454
    450
    112
    448
    19
    Completed
    443
    434
    104
    437
    19
    Not completed
    11
    17
    8
    11
    0
         Adverse event, serious fatal
    -
    1
    -
    -
    -
         Physician decision
    1
    1
    -
    -
    -
         Consent withdrawn by subject
    3
    4
    3
    2
    -
         Screen Failure
    -
    1
    -
    -
    -
         Adverse event, non-fatal
    2
    2
    1
    3
    -
         Lost to follow-up
    3
    5
    2
    3
    -
         Lack of efficacy
    1
    3
    2
    2
    -
         Protocol deviation
    1
    -
    -
    1
    -
    Period 2
    Period 2 title
    Maintenance Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250mg Q8W Mirikizumab
    Arm description
    		 Participants received 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period.

    Arm title
    		 125mg Q8W Mirikizumab
    Arm description
    		 Participants received 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period.

    Arm title
    		 250mg Mirikizumab
    Arm description
    		 Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period.

    Arm title
    		 300mg Secukinumab
    Arm description
    		 Participants received 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.

    Arm title
    		 Japan GPP/EP
    Arm description
    		 Participants received 250mg Q8W by SC injection in maintenance period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Mirikizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled injector
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received 250mg Q8W by SC injection in maintenance period.

    Number of subjects in period 2
    		250mg Q8W Mirikizumab 125mg Q8W Mirikizumab 250mg Mirikizumab 300mg Secukinumab Japan GPP/EP
    Started
    443
    434
    104
    437
    19
    Completed
    421
    418
    96
    400
    13
    Not completed
    22
    16
    8
    37
    6
         Physician decision
    1
    2
    -
    2
    -
         Consent withdrawn by subject
    7
    2
    1
    8
    -
         Adverse event, non-fatal
    6
    5
    1
    11
    4
         Unknown
    1
    2
    -
    -
    -
         Pregnancy
    -
    -
    -
    2
    -
         Lost to follow-up
    4
    2
    1
    5
    2
         Lack of efficacy
    3
    2
    5
    9
    -
         Protocol deviation
    -
    1
    -
    -
    -
    Period 3
    Period 3 title
    Post-Treatment Followup Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 250mg Q4W/250mg Q8W Mirikizumab
    Arm description
    		 .Participants did not receive any intervention in post-treatment follow-up period.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 250mg Q4W/125mg Q8W Mirikizumab
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Placebo/250mg Mirikizumab
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 300mg Secukinumab
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Japan GPP/EP
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 3 [1]
    		250mg Q4W/250mg Q8W Mirikizumab 250mg Q4W/125mg Q8W Mirikizumab Placebo/250mg Mirikizumab 300mg Secukinumab Japan GPP/EP
    Started
    38
    35
    18
    47
    8
    Completed
    27
    21
    7
    23
    8
    Not completed
    11
    14
    11
    24
    0
         Consent withdrawn by subject
    2
    2
    3
    6
    -
         Physician decision
    -
    2
    1
    1
    -
         Adverse event, non-fatal
    4
    5
    1
    8
    -
         Unknown
    1
    -
    -
    5
    -
         Lost to follow-up
    1
    1
    1
    -
    -
         Lack of efficacy
    3
    4
    5
    4
    -
    Notes
    [1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Participants who discontinued/completed Induction/Maintenance had option to enter posttreatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    250mg Q4W Mirikizumab
    Reporting group description
    		 Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    250mg Q4W Mirikizumab
    Reporting group description
    		 Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.

    Reporting group title
    300mg Secukinumab
    Reporting group description
    		 Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.

    Reporting group title
    Japan GPP/EP
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W by SC injection during induction period. A plaque psoriasis participant was misrandomized by the site.

    Reporting group values
    		 250mg Q4W Mirikizumab 250mg Q4W Mirikizumab Placebo 300mg Secukinumab Japan GPP/EP Total
    Number of subjects
    		 454 451 112 448 19 1484
    Age categorical
    Units: Subjects
        <65
    		 417 398 103 399 14 1331
        >=65
    		 37 53 9 49 5 153
    Gender categorical
    Units: Subjects
        Female
    		 158 140 30 137 1 466
        Male
    		 296 311 82 311 18 1018
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 9 15 4 10 0 38
        Not Hispanic or Latino
    		 79 71 12 72 0 234
        Unknown or Not Reported
    		 366 365 96 366 19 1212
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 2 2 1 2 0 7
        Asian
    		 81 66 12 70 19 248
        Native Hawaiian or Other Pacific Islander
    		 1 1 0 1 0 3
        Black or African American
    		 7 7 2 8 0 24
        White
    		 361 372 97 365 0 1195
        More than one race
    		 2 2 0 2 0 6
        Unknown or Not Reported
    		 0 1 0 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    250mg Q4W Mirikizumab
    Reporting group description
    		 Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    250mg Q4W Mirikizumab
    Reporting group description
    		 Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.

    Reporting group title
    300mg Secukinumab
    Reporting group description
    		 Participants received 300mg Secukinumab at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during induction period.

    Reporting group title
    Japan GPP/EP
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W by SC injection during induction period. A plaque psoriasis participant was misrandomized by the site.
    Reporting group title
    250mg Q8W Mirikizumab
    Reporting group description
    		 Participants received 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    125mg Q8W Mirikizumab
    Reporting group description
    		 Participants received 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    250mg Mirikizumab
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 in maintenance period. Participants received matching placebo to blind Secukinumab.

    Reporting group title
    300mg Secukinumab
    Reporting group description
    		 Participants received 300mg Secukinumab Q4W from week 16 to 52 in maintenance period.

    Reporting group title
    Japan GPP/EP
    Reporting group description
    		 Participants received 250mg Q8W by SC injection in maintenance period.
    Reporting group title
    250mg Q4W/250mg Q8W Mirikizumab
    Reporting group description
    		 .Participants did not receive any intervention in post-treatment follow-up period.

    Reporting group title
    250mg Q4W/125mg Q8W Mirikizumab
    Reporting group description
    		 -

    Reporting group title
    Placebo/250mg Mirikizumab
    Reporting group description
    		 -

    Reporting group title
    300mg Secukinumab
    Reporting group description
    		 -

    Reporting group title
    Japan GPP/EP
    Reporting group description
    		 -

    Subject analysis set title
    Mirikizumab 250mg Q4W/250mg Q8W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 250 Milligrams (mg) Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 250mg Mirikizumab once every eight weeks (Q8W) in maintenance period.

    Subject analysis set title
    250mg Mirikizumab /125mg Q8W
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 250 Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period followed by 125mg Mirikizumab once every eight weeks (Q8W) in maintenance period.

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received matching placebo at weeks 0, 1, 2, 3, 4, 8, and 12 by subcutaneous injection during blinded induction period.

    Subject analysis set title
    250mg Q4W Mirikizumab
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants received 250 mg Mirikizumab once Q4W by subcutaneous injection during blinded induction period.

    Primary: Percentage of Participants with a Static Physician’s Global Assessment (sPGA) of (0,1) with at Least a 2-point Improvement from Baseline

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    End point title
    		 Percentage of Participants with a Static Physician’s Global Assessment (sPGA) of (0,1) with at Least a 2-point Improvement from Baseline [1]
    End point description
    The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Analysis population description (APD): All randomized participants.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    76.3 (72.4 to 80.3)
    6.3 (1.8 to 10.7)
    79.7 (77.0 to 82.3)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v 250mg Q4W Mirikizumab
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    73.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 68.2
         upper limit
    		 78.7

    Primary: Percentage of Participants Achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline

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    End point title
    		 Percentage of Participants Achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline [2]
    End point description
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). APD: All randomized participants.
    End point type
    Primary
    End point timeframe
    Week 16
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    72.8 (68.6 to 76.9)
    6.3 (1.8 to 10.7)
    74.4 (71.5 to 77.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 62.7
         upper limit
    		 73.3

    Secondary: Percentage of Participants Achieving a 75% Improvement in PASI 75

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    End point title
    		 Percentage of Participants Achieving a 75% Improvement in PASI 75 [3]
    End point description
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    89.5 (86.7 to 92.3)
    8.0 (3.0 to 13.1)
    89.5 (87.5 to 91.5)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    81.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 76.1
         upper limit
    		 87

    Secondary: Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement

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    End point title
    		 Percentage of Participants with ≤1% of Body Surface Area (BSA) with Psoriasis Involvement [4]
    End point description
    The BSA is the percentage involvement of psoriasis on each participant's body surface on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The total BSA affected was the summation of individual regions affected. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    54.5 (49.9 to 59.1)
    1.8 (0.0 to 4.2)
    53.1 (49.9 to 56.4)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    51.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.6
         upper limit
    		 55.8

    Secondary: Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those with PSS Symptom Score of ≥1 at Baseline

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    End point title
    		 Percentage of Participants with a Psoriasis Symptoms Scale (PSS) Symptom Score of 0 in Those with PSS Symptom Score of ≥1 at Baseline [5]
    End point description
    PSS is a patient-administered assessment of 4 symptoms (itch, pain, stinging, and burning); 3 signs (redness, scaling, and cracking); and 1 item on the discomfort related to symptoms/signs. The overall severity for each individual symptom/sign from the patient's psoriasis is indicated by selecting the number from a numeric rating scale (NRS) of 0 to 10 that best describes the worst level of each symptom/sign in the past 24 hours, where 0=no symptom/sign and 10=worst imaginable symptom/sign. In addition, a symptoms score ranging from 0 (no symptoms) to 40 (worst imaginable symptoms), and a signs score of 0 (no signs) to 30 (worst imaginable signs) will be reported. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. APD: All randomized participants with PSS symptom score of ≥1 at baseline.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    414
    108
    849
    Units: percentage of participants
        number (confidence interval 95%)
    28.7 (24.4 to 33.1)
    1.9 (0.0 to 4.4)
    25.0 (22.1 to 27.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    957
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    23.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 19.3
         upper limit
    		 27.1

    Secondary: Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5

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    End point title
    		 Percentage of Participants Achieving a Dermatology Life Quality Index (DLQI) Total Score of (0,1) with at Least a 5-Point Improvement (Reduction) from Baseline in Participants with a Baseline DLQI Total Score ≥5 [6]
    End point description
    The DLQI is a patient-reported, 10-question, quality-of-life questionnaire that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "Not at all," "A little," "A lot," and "Very much," with corresponding scores of 0, 1, 2, and 3 respectively. Questions 3-10 also have an additional response category of "Not relevant" which is scored as "0". For all questions, if unanswered the question is scored as "0". Totals range from 0 to 30 (less to more impairment). A DLQI total score of 0 to 1 is considered as having no effect on a patient's health-related quality of life (HRQoL), and a 5-point change from baseline is considered as the minimal clinically important difference (MCID) threshold. Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100.
    End point type
    Secondary
    End point timeframe
    Week 16 APD: All randomized participants with baseline DLQI Total Score ≥5.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    396
    101
    821
    Units: percentage of participants
        number (confidence interval 95%)
    60.4 (55.5 to 65.2)
    5.9 (1.3 to 10.6)
    59.6 (56.2 to 62.9)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    922
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    53.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 47.7
         upper limit
    		 59.3

    Secondary: Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline

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    End point title
    		 Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) Total Score in Participants with Palmoplantar Involvement at Baseline [7]
    End point description
    The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. Least Squares Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) model with treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, and previous exposure to biologic therapy (yes/no), body weight (<100 kg or >=100 kg), and geographic region (North America or Other) as covariates. APD: All randomized participants who had palmoplantar involvement at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    84
    18
    191
    Units: Score on a scale
        least squares mean (standard error)
    -5.79 ± 0.541
    -1.33 ± 1.030
    -6.28 ± 0.383
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    209
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -4.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.01
         upper limit
    		 -2.88
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.05

    Secondary: Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline

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    End point title
    		 Change in Psoriasis Scalp Severity Index (PSSI) Total Score in Participants with Scalp Involvement at Baseline [8]
    End point description
    The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity). APD: All randomized participants who had scalp Involvement at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    387
    90
    789
    Units: Score on a scale
        least squares mean (standard error)
    -18.22 ± 0.365
    -3.62 ± 0.676
    -18.78 ± 0.286
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    879
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -15.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -16.51
         upper limit
    		 -13.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.692

    Secondary: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline

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    End point title
    		 Change from Baseline in Nail Psoriasis Severity Index (NAPSI) Total Score in Participants with Fingernail Involvement at Baseline [9]
    End point description
    The NAPSI scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix PsO by area of involvement. The fingernail is divided into quadrants. Each fingernail is given a score for fingernail bed PsO 0 (none) to 4 (PsO in 4 quadrants of the fingernail) and fingernail matrix PsO 0 (none) to 4 (Ps in 4 quadrants of the matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix PsO in each quadrant. The sum of all fingernails equals the total NAPSI score range is from 0 (no effect) to 80 (more severe psoriasis). APD: All randomized participants who had Nail Psoriasis involvement at baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    235
    54
    492
    Units: Score on a scale
        least squares mean (standard error)
    -11.24 ± 0.774
    0.20 ± 1.494
    -9.38 ± 0.580
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    546
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Mixed models analysis
    Parameter type
    		 LSMean Difference
    Point estimate
    -9.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.63
         upper limit
    		 -6.55
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.55

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

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    End point title
    		 Change from Baseline on the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS) [10]
    End point description
    SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: Score on a scale
        least squares mean (standard error)
    4.38 ± 0.358
    0.57 ± 0.633
    4.03 ± 0.291
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LSMean Difference
    Point estimate
    3.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 4.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.642

    Secondary: Change from Baseline on the SF-36 Mental Component Summary (MCS)

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    End point title
    		 Change from Baseline on the SF-36 Mental Component Summary (MCS) [11]
    End point description
    SF-36 consists of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality. The patient's responses are solicited using Likert scales that vary in length, with 3-6 response options per item. The SF-36 can be scored into the 8 health domains named above and two overall summary scores: physical component summary (PCS) and mental component summary (MCS) scores. The domain and summary scores range from 0 to 100; higher scores indicate better levels of function and/or better health. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: Score on a scale
        least squares mean (standard error)
    4.21 ± 0.398
    0.50 ± 0.701
    4.45 ± 0.321
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    1017
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LSMean Difference
    Point estimate
    3.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.56
         upper limit
    		 5.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.711

    Secondary: Percenatage of Participants achieving Patient’s Global Assessment (PatGA) of disease severity of (0,1) with at least a 2-point improvement from baseline in patients with a baseline PatGA ≥2

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    End point title
    		 Percenatage of Participants achieving Patient’s Global Assessment (PatGA) of disease severity of (0,1) with at least a 2-point improvement from baseline in patients with a baseline PatGA ≥2 [12]
    End point description
    The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). Percentage response is calculated by number of participants with a response divided by number of participants with non-missing values multiplied by 100. APD: All randomized participants with non missing baseline PatGA >=2 data.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    433
    110
    883
    Units: percentage of participants
        number (confidence interval 95%)
    71.8 (67.6 to 76.1)
    7.3 (2.4 to 12.1)
    72.3 (69.3 to 75.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    993
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.3
         upper limit
    		 70.8

    Secondary: Change from baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores

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    End point title
    		 Change from baseline for the Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI-PSO) Scores [13]
    End point description
    The WPAI-PSO consists of 6 questions to determine employment status, hours missed from work because of psoriasis, hours missed from work for other reasons, hours actually worked, the degree to which psoriasis affected work productivity while at work, and the degree to which psoriasis affected activities outside of work. Four scores are derived: absenteeism, presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism and impairment in activities performed outside of work. Each WPAI score is expressed as impairment percentages (0-100) with higher numbers indicating greater impairment and less productivity, that is, worse outcomes. APD: All randomized participants with baseline employment status of yes.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    320
    84
    617
    Units: Score on a scale
    least squares mean (standard error)
        Absenteeism
    -2.48 ± 0.995
    -0.48 ± 1.753
    -2.20 ± 0.844
        Presenteeism
    -18.95 ± 1.204
    -3.36 ± 2.104
    -18.95 ± 1.020
        Overall work impairment
    -18.49 ± 1.401
    -2.77 ± 2.448
    -19.21 ± 1.187
        Impairment in Activities Performed Outside of Work
    -25.71 ± 1.061
    -5.86 ± 1.847
    -24.17 ± 0.885
    No statistical analyses for this end point

    Secondary: Change from Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those with a Baseline QIDS-SR16 Total Score ≥11.

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    End point title
    		 Change from Baseline in Quick Inventory of Depressive Symptomatology (QIDS-SR16) Total Score in Those with a Baseline QIDS-SR16 Total Score ≥11. [14]
    End point description
    QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity. Whereas 0-5 indicates no symptoms. APD: All participants who had a baseline QIDS-SR16 total score >=11.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    44
    5
    93
    Units: score on a scale
        least squares mean (standard error)
    -5.10 ± 0.935
    -4.79 ± 2.266
    -5.28 ± 0.733
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    250mg Q4W Mirikizumab v Placebo
    Number of subjects included in analysis
    98
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.826
    Method
    		 ANCOVA
    Parameter type
    		 LSMean Difference
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.96
         upper limit
    		 3.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.255

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

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    End point title
    		 Pharmacokinetics: Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Mirikizumab
    End point description
    Minimum observed serum Ctrough,ss of Mirikizumab. Analysis population description: All randomized participants who received at least one dose of study drug and had evaluable PK samples.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 250mg Q4W Mirikizumab
    Number of subjects analysed
    809
    Units: Microgram per milliliter
        geometric mean (geometric coefficient of variation)
    2.40 ± 112
    No statistical analyses for this end point

    Secondary: Percentage of Participants with a Static Physician's Global Assessment (sPGA) of (0,1) with at Least a 2-point Improvement from Baseline (Non-inferiority)

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    End point title
    		 Percentage of Participants with a Static Physician's Global Assessment (sPGA) of (0,1) with at Least a 2-point Improvement from Baseline (Non-inferiority) [15]
    End point description
    The sPGA is the physician's determination of the participant's psoriasis lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's psoriasis was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    76.3 (72.4 to 80.3)
    6.3 (1.8 to 10.7)
    79.7 (77.0 to 82.3)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    300mg Secukinumab v 250mg Q4W Mirikizumab
    Number of subjects included in analysis
    1353
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    3.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.4
         upper limit
    		 7.9

    Secondary: Percentage of Participants Achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline (Non-inferiority)

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    End point title
    		 Percentage of Participants Achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) from Baseline (Non-inferiority) [16]
    End point description
    PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis (PsO) to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no PsO) to 72 (the most severe disease). APD: All randomized participants.
    End point type
    Secondary
    End point timeframe
    Week 16
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis was not planned to be reported for all arms.
    End point values
    		 300mg Secukinumab Placebo 250mg Q4W Mirikizumab
    Number of subjects analysed
    448
    112
    905
    Units: percentage of participants
        number (confidence interval 95%)
    72.8 (68.6 to 76.9)
    6.3 (1.8 to 10.7)
    74.4 (71.5 to 77.2)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    300mg Secukinumab v 250mg Q4W Mirikizumab
    Number of subjects included in analysis
    1353
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Risk difference (RD)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.4
         upper limit
    		 6.6

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 64 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    Placebo / Induction Period
    Reporting group description
    		 Participants received matching placebo by subcutaneous injection in induction period.

    Reporting group title
    300mg Secukinumab / Induction Period
    Reporting group description
    		 Participants received matching placebo by subcutaneous injection in induction period.

    Reporting group title
    250 Mirikizumab Q4W / Induction Period
    Reporting group description
    		 Participants received 250mg Mirikizumab once every four weeks (Q4W) by subcutaneous injection during blinded induction period.

    Reporting group title
    250 Mirikizumab Q4W - Japan GPP/EP / Induction Period
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W by subcutaneous injection in induction period.

    Reporting group title
    300 Secukinumab / Maintenance Period
    Reporting group description
    		 Participants received 300mg Secukinumab Q4W by subcutaneous injection from week 16 to 52 in maintenance period.

    Reporting group title
    125 Mirikizumab Q8W / Maintenance Period
    Reporting group description
    		 Participants received 125mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period.

    Reporting group title
    250 Mirikizumab Q8W / Maintenance Period
    Reporting group description
    		 Participants received 250mg Mirikizumab once every eight weeks (Q8W) by subcutaneous injection in maintenance period.

    Reporting group title
    250mg Mirikizumab / Maintenance Period
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 by subcutaneous injection in maintenance period.

    Reporting group title
    250 Mirikizumab Q8W - Japan GPP/EP / Maintenance Period
    Reporting group description
    		 Participants received 250mg Mirikizumab Q4W from week 16 to 32 followed by 250mg Mirikizumab Q8W from week 32 to 48 by subcutaneous injection in maintenance period.

    Reporting group title
    Placebo / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    300mg Secukinumab / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    250 Mirikizumab Q4W / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    250 Mirikizumab Q4W - Japan GPP/EP / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    250 Mirikizumab Q4W/125 Mirikizumab Q8W / Follow-up Period
    Reporting group description
    		 -

    Reporting group title
    Placebo/250 Mirikizumab / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    250 Mirikizumab Q4W/250 Mirikizumab Q8W / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    250 Miriki Q4W/250 Miri Q8W - Japan GPP/EP / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Reporting group title
    300 Secukinumab/300 Secukinumab / Follow-up Period
    Reporting group description
    		 Participants did not receive any intervention in post- treatment follow-up period.

    Serious adverse events
    		 Placebo / Induction Period 300mg Secukinumab / Induction Period 250 Mirikizumab Q4W / Induction Period 250 Mirikizumab Q4W - Japan GPP/EP / Induction Period 300 Secukinumab / Maintenance Period 125 Mirikizumab Q8W / Maintenance Period 250 Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250 Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250 Mirikizumab Q4W / Follow-up Period 250 Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250 Mirikizumab Q4W/125 Mirikizumab Q8W / Follow-up Period Placebo/250 Mirikizumab / Follow-up Period 250 Mirikizumab Q4W/250 Mirikizumab Q8W / Follow-up Period 250 Miriki Q4W/250 Miri Q8W - Japan GPP/EP / Follow-up Period 300 Secukinumab/300 Secukinumab / Follow-up Period
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 112 (0.00%)
    11 / 448 (2.46%)
    15 / 904 (1.66%)
    2 / 19 (10.53%)
    15 / 437 (3.43%)
    13 / 434 (3.00%)
    10 / 443 (2.26%)
    0 / 104 (0.00%)
    3 / 18 (16.67%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    3 / 29 (10.34%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         number of deaths (all causes)
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    breast cancer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    gallbladder cancer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    haemangioma of skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    lung adenocarcinoma stage i
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    malignant melanoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    non-small cell lung cancer stage iv
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    prostate cancer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    Vascular disorders
    hypertension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    gender reassignment therapy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    hernia repair
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    mammoplasty
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    tenotomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    chest pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    Immune system disorders
    anaphylactic shock
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    bipolar disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    Investigations
    liver function test abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    concussion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
         deaths causally related to 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
    fibula fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    incisional hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    meniscus injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    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
    pulmonary contusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    radius fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    skin laceration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    spinal compression fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    tibia fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    acute myocardial infarction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    angina pectoris
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    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
    atrial fibrillation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    atrial flutter
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    congestive cardiomyopathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    coronary artery disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
         deaths causally related to 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
    myocardial infarction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    cerebral infarction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    ischaemic stroke
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    monoplegia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    nerve compression
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    sacral radiculopathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    Ear and labyrinth disorders
    hypoacusis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    crohn's disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diarrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    enlarged uvula
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    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
    incarcerated inguinal hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    inguinal hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    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
         deaths causally related to 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
    irritable bowel syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 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
    pancreatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pancreatitis acute
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    umbilical hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholecystitis acute
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    Skin and subcutaneous tissue disorders
    psoriasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    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
         deaths causally related to 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
    pustular psoriasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    nephrolithiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    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
         deaths causally related to 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
    Musculoskeletal and connective tissue disorders
    enthesopathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    symphysiolysis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    anal abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    appendicitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to 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
    cellulitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    diverticulitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    erysipelas
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    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
    meningitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (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
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    pyelonephritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    sinusitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    wound infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo / Induction Period 300mg Secukinumab / Induction Period 250 Mirikizumab Q4W / Induction Period 250 Mirikizumab Q4W - Japan GPP/EP / Induction Period 300 Secukinumab / Maintenance Period 125 Mirikizumab Q8W / Maintenance Period 250 Mirikizumab Q8W / Maintenance Period 250mg Mirikizumab / Maintenance Period 250 Mirikizumab Q8W - Japan GPP/EP / Maintenance Period Placebo / Follow-up Period 300mg Secukinumab / Follow-up Period 250 Mirikizumab Q4W / Follow-up Period 250 Mirikizumab Q4W - Japan GPP/EP / Follow-up Period 250 Mirikizumab Q4W/125 Mirikizumab Q8W / Follow-up Period Placebo/250 Mirikizumab / Follow-up Period 250 Mirikizumab Q4W/250 Mirikizumab Q8W / Follow-up Period 250 Miriki Q4W/250 Miri Q8W - Japan GPP/EP / Follow-up Period 300 Secukinumab/300 Secukinumab / Follow-up Period
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 112 (60.71%)
    257 / 448 (57.37%)
    520 / 904 (57.52%)
    14 / 19 (73.68%)
    292 / 437 (66.82%)
    271 / 434 (62.44%)
    282 / 443 (63.66%)
    0 / 104 (0.00%)
    14 / 18 (77.78%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    1 / 1 (100.00%)
    3 / 29 (10.34%)
    4 / 14 (28.57%)
    6 / 35 (17.14%)
    2 / 6 (33.33%)
    7 / 43 (16.28%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    anogenital warts
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    b-cell lymphoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    basal cell carcinoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    4
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysplastic naevus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lentigo maligna
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lip neoplasm malignant stage unspecified
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lipoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lung adenocarcinoma stage i
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    melanocytic naevus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neoplasm
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neoplasm skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oral fibroma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    prostate cancer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin papilloma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    squamous cell carcinoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    uterine leiomyoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Vascular disorders
    arteriosclerosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    deep vein thrombosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    essential hypertension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hot flush
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypertension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    4 / 112 (3.57%)
    9 / 448 (2.01%)
    24 / 904 (2.65%)
    0 / 19 (0.00%)
    9 / 437 (2.06%)
    8 / 434 (1.84%)
    8 / 443 (1.81%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    4
    9
    25
    0
    9
    8
    8
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypotension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    orthostatic hypotension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    peripheral venous disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    phlebitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    raynaud's phenomenon
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    thrombophlebitis superficial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    varicose vein
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    venous thrombosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    white coat hypertension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Surgical and medical procedures
    abscess drainage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    antiviral prophylaxis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    bile duct stent insertion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    cataract operation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cervix cryotherapy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cholangiostomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    cholecystectomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dental care
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dental implantation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dental prosthesis placement
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    endodontic procedure
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    female sterilisation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    foot operation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hernia repair
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    infusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    intestinal polypectomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    joint surgery
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lens extraction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    limb operation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lipoma excision
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mass excision
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    meniscus removal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nephrostomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    percutaneous coronary intervention
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    phlebectomy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rehabilitation therapy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    removal of foreign body
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rotator cuff repair
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    shoulder operation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin neoplasm excision
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth extraction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    2
    0
    2
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    varicose vein operation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    4 / 434 (0.92%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    2
    0
    1
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chest discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chest pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dehiscence
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    fatigue
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    6 / 448 (1.34%)
    15 / 904 (1.66%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    6 / 434 (1.38%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    6
    16
    0
    5
    6
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    general physical health deterioration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    granuloma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    inflammation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    influenza like illness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    5 / 434 (1.15%)
    6 / 443 (1.35%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    5
    0
    5
    6
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site bruising
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site erythema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    13 / 904 (1.44%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    4
    27
    0
    0
    6
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site haematoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site hypersensitivity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site induration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site inflammation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site oedema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    3 / 434 (0.69%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    4 / 112 (3.57%)
    1 / 448 (0.22%)
    21 / 904 (2.32%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    8 / 434 (1.84%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    28
    6
    109
    0
    11
    38
    28
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site papule
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site paraesthesia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site pruritus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    8
    0
    0
    8
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site reaction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    4 / 448 (0.89%)
    26 / 904 (2.88%)
    1 / 19 (5.26%)
    3 / 437 (0.69%)
    14 / 434 (3.23%)
    14 / 443 (3.16%)
    0 / 104 (0.00%)
    2 / 18 (11.11%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    7
    64
    2
    4
    24
    35
    0
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injection site swelling
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    malaise
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    non-cardiac chest pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oedema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oedema peripheral
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    3
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    peripheral swelling
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pyrexia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    6
    0
    4
    4
    4
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    swelling face
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tenderness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    xerosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Immune system disorders
    allergy to arthropod bite
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    food allergy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypersensitivity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    multiple allergies
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rubber sensitivity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    seasonal allergy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    3 / 434 (0.69%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    4
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    selective igg subclass deficiency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Social circumstances
    menopause
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    stress at work
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Reproductive system and breast disorders
    amenorrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    balanoposthitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    benign prostatic hyperplasia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    breast calcifications
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    breast mass
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    breast pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysmenorrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    10
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ectropion of cervix
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erectile dysfunction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    menstruation irregular
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    metrorrhagia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oligospermia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ovarian cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    penile erythema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus genital
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    testicular pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vulvovaginal dryness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vulvovaginal pruritus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    asthma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    5
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    bronchial hyperreactivity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cough
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    4 / 112 (3.57%)
    7 / 448 (1.56%)
    13 / 904 (1.44%)
    0 / 19 (0.00%)
    12 / 437 (2.75%)
    7 / 434 (1.61%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    2 / 35 (5.71%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    4
    7
    13
    0
    14
    9
    6
    0
    1
    0
    0
    0
    0
    0
    0
    2
    0
    0
    dysphonia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dyspnoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    epistaxis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypoxia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    interstitial lung disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    laryngeal pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lower respiratory tract congestion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasal congestion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    6
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasal discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasal polyps
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasal septum deviation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oropharyngeal pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    11 / 448 (2.46%)
    7 / 904 (0.77%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    4 / 434 (0.92%)
    11 / 443 (2.48%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    12
    7
    0
    6
    4
    11
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    paranasal sinus discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pharyngeal erythema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    productive cough
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pulmonary embolism
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pulmonary mass
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    respiratory disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    respiratory distress
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rhinitis allergic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    6 / 437 (1.37%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    4
    0
    6
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rhinorrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    4
    0
    4
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sinus congestion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sneezing
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    throat tightness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Psychiatric disorders
    abnormal dreams
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    acute stress disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    adjustment disorder with depressed mood
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    alcoholic psychosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    anxiety
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    4
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    anxiety disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    attention deficit hyperactivity disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    burnout syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    depressed mood
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    depression
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    insomnia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    1
    9
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    irritability
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    libido decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    loss of libido
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mood altered
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    panic attack
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sleep disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    6
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    social anxiety disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    stress
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Product issues
    device breakage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    device physical property issue
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    biliary dilatation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cholelithiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    drug-induced liver injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatic fibrosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatic function abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatic pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatic steatosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pneumobilia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    2 / 434 (0.46%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    4
    1
    0
    4
    2
    4
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    anti-actin antibody positive
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    0
    0
    2
    1
    5
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    aspiration joint
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    biopsy skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    blood bilirubin increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood cholesterol increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood creatine increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood creatine phosphokinase abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    12 / 904 (1.33%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    7 / 434 (1.61%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    12
    0
    3
    8
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood glucose increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood iron decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood potassium increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood pressure increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood thyroid stimulating hormone decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood triglycerides increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    0 / 434 (0.00%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    1
    0
    4
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blood uric acid increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    body temperature increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    female sex hormone level abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    fibrin d dimer increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gamma-glutamyltransferase abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haemoglobin increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatic enzyme increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hepatitis e virus test positive
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    liver function test abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    liver function test increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymph node palpable
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphocyte count decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphocyte morphology abnormal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mammogram
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neutrophil count increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neutrophil count decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    occult blood
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    panendoscopy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    platelet count decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    platelet count increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    prostatic specific antigen increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    protein urine present
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    red blood cell count decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    transaminases increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    very low density lipoprotein increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vitamin d decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    weight decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    3 / 434 (0.69%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    weight increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    4 / 434 (0.92%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    3
    0
    3
    4
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    white blood cell count decreased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    white blood cell count increased
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    arthropod bite
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    arthropod sting
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chemical burn
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    concussion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    contusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    4 / 434 (0.92%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    3
    0
    5
    4
    3
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    craniocerebral injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    epicondylitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    eye contusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    face injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    fall
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    6
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    foot fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    2
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hand fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    head injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    heat stroke
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    humerus fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    injury corneal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    joint dislocation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    joint injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ligament injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ligament sprain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    5 / 434 (1.15%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    6
    0
    1
    7
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    limb crushing injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    limb injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    4
    0
    0
    1
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    limb fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lower limb fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mallet finger
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    meniscus injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    multiple injuries
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle strain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    7 / 904 (0.77%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    8
    0
    0
    4
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle rupture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    patella fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    post-traumatic neck syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    post-traumatic pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    procedural pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    radius fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rib fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    road traffic accident
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    scratch
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin abrasion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin laceration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    3
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin wound
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sternal injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tendon rupture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    thermal burn
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    traumatic haematoma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    traumatic ulcer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    upper limb fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    wound
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    wrist fracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Congenital, familial and genetic disorders
    distichiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Cardiac disorders
    angina pectoris
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    atrial fibrillation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    coronary artery disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    palpitations
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sinus tachycardia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tachycardia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ventricular extrasystoles
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nervous system disorders
    burning sensation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    carpal tunnel syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cervicobrachial syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    disturbance in attention
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dizziness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 448 (0.00%)
    9 / 904 (1.00%)
    1 / 19 (5.26%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    10
    1
    1
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysaesthesia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysgeusia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    facial paralysis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    headache
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    4 / 112 (3.57%)
    24 / 448 (5.36%)
    44 / 904 (4.87%)
    0 / 19 (0.00%)
    9 / 437 (2.06%)
    16 / 434 (3.69%)
    19 / 443 (4.29%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    4
    27
    63
    0
    14
    20
    38
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    hypertonia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypoaesthesia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    3
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    loss of consciousness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    migraine
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    5
    3
    0
    4
    2
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nerve compression
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neuralgia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    notalgia paraesthetica
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    paraesthesia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    presyncope
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sciatica
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    senile dementia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sinus headache
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    somnolence
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    syncope
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    taste disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tension headache
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    trigeminal neuralgia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eosinophilia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    iron deficiency anaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    leukocytosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    leukopenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphadenitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphadenopathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lymphopenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neutropenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neutrophilia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    thrombocytopenia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Ear and labyrinth disorders
    auditory disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cerumen impaction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear swelling
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypoacusis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tinnitus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vertigo
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    1 / 19 (5.26%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    1
    1
    0
    4
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vertigo positional
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Eye disorders
    blepharitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cataract
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chalazion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    conjunctival haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    conjunctivitis allergic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    2
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    corneal disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dry eye
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erythema of eyelid
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye irritation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye pruritus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eyelid oedema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypermetropia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    meibomianitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    posterior capsule opacification
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vision blurred
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    abdominal discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    2
    0
    0
    1
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abdominal distension
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abdominal pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    2 / 448 (0.45%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    4 / 434 (0.92%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    2
    5
    0
    9
    4
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abdominal pain lower
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abdominal pain upper
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 448 (0.45%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    1
    2
    2
    0
    2
    2
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    abdominal tenderness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    acquired oesophageal web
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    anal fissure
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    aphthous ulcer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chilaiditi's syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chronic gastritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    constipation
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    4 / 904 (0.44%)
    2 / 19 (10.53%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    2
    4
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    crohn's disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dental caries
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    diarrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    17 / 448 (3.79%)
    17 / 904 (1.88%)
    1 / 19 (5.26%)
    5 / 437 (1.14%)
    6 / 434 (1.38%)
    9 / 443 (2.03%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    2
    37
    19
    1
    27
    6
    10
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    diverticulum intestinal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    dry mouth
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    duodenitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dyspepsia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    4
    8
    0
    0
    4
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysphagia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    enlarged uvula
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    enteritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    faeces soft
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    flatulence
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    food poisoning
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    frequent bowel movements
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastric disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastric polyps
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    3 / 434 (0.69%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    7
    3
    0
    10
    3
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastrolithiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    2
    0
    1
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastrooesophageal sphincter insufficiency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gingival bleeding
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gingival pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    glossitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haematochezia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haemorrhoids
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hiatus hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    inflammatory bowel disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    inguinal hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    intestinal polyp
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    irritable bowel syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    1 / 1 (100.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    large intestine polyp
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    loose tooth
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lumbar hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nausea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    10 / 904 (1.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    10
    0
    0
    2
    3
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    odynophagia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oral pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    paraesthesia oral
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    peptic ulcer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    saliva altered
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    stomatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tongue discolouration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    toothache
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    4 / 448 (0.89%)
    8 / 904 (0.88%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    2 / 434 (0.46%)
    7 / 443 (1.58%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    4
    4
    10
    0
    6
    4
    8
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    traumatic occlusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    umbilical hernia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vomiting
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    3 / 448 (0.67%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    3
    4
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    acanthosis nigricans
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    acne
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    6
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    actinic keratosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    4
    0
    4
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    alopecia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    alopecia areata
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    angioedema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    asteatosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    blister
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dermal cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dermatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dermatitis allergic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dermatitis contact
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    4 / 448 (0.89%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    5 / 434 (1.15%)
    9 / 443 (2.03%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    4
    5
    0
    5
    5
    9
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    1
    drug eruption
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dry skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    3
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dyshidrotic eczema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ecchymosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eczema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    11 / 904 (1.22%)
    1 / 19 (5.26%)
    10 / 437 (2.29%)
    6 / 434 (1.38%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    14
    1
    11
    6
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eczema asteatotic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eczema nummular
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erythema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    granuloma annulare
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hand dermatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyperhidrosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ingrown hair
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    intertrigo
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    1
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    keratosis pilaris
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lentigo
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    leukoplakia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lichen planus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lichen sclerosus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    macule
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    miliaria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    myxoid cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nail psoriasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    night sweats
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    onychoclasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pain of skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    papule
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    papulopustular rosacea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    petechiae
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    photosensitivity reaction
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    photodermatosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pityriasis rosea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pityriasis rubra pilaris
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    polymorphic light eruption
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    post inflammatory pigmentation change
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    4 / 448 (0.89%)
    22 / 904 (2.43%)
    2 / 19 (10.53%)
    8 / 437 (1.83%)
    2 / 434 (0.46%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    4
    4
    22
    2
    8
    2
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    prurigo
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pruritus allergic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    psoriasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    purpura
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rash
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    1
    0
    2
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rash papular
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rash pruritic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rash vesicular
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rosacea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    seborrhoea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    seborrhoeic dermatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    2
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sensitive skin
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin atrophy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin fissures
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin mass
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin ulcer
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    solar dermatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    toxic skin eruption
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    urticaria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    8 / 904 (0.88%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    3 / 434 (0.69%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    10
    0
    2
    3
    4
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    urticaria cholinergic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    urticaria chronic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    xeroderma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Renal and urinary disorders
    acute kidney injury
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    calculus urinary
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dysuria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    haematuria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    micturition urgency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nephrolithiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    0
    0
    2
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    nocturia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pollakiuria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    renal colic
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    renal failure
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Endocrine disorders
    adrenal insufficiency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    goitre
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypothyroidism
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    3 / 112 (2.68%)
    5 / 448 (1.12%)
    20 / 904 (2.21%)
    0 / 19 (0.00%)
    8 / 437 (1.83%)
    18 / 434 (4.15%)
    13 / 443 (2.93%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    5
    5
    25
    0
    9
    19
    17
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    arthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    back pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    5 / 112 (4.46%)
    3 / 448 (0.67%)
    22 / 904 (2.43%)
    0 / 19 (0.00%)
    13 / 437 (2.97%)
    19 / 434 (4.38%)
    19 / 443 (4.29%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    5
    4
    22
    0
    14
    19
    22
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    bone pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    bursitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chondrocalcinosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    connective tissue disorder
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    enthesopathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    exostosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    facet joint syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    flank pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    foot deformity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    inclusion body myositis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    intervertebral disc degeneration
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    3
    0
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    joint swelling
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle contracture
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle spasms
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    3 / 434 (0.69%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    3
    0
    4
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscle tightness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    muscular weakness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    3 / 434 (0.69%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal discomfort
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    8 / 904 (0.88%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    7 / 443 (1.58%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    4
    8
    0
    0
    0
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    myalgia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    10 / 904 (1.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    10
    0
    2
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    myositis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    neck pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    5
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    osteoarthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    5 / 434 (1.15%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    2
    0
    3
    5
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    osteitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pain in extremity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    5 / 434 (1.15%)
    8 / 443 (1.81%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    6
    0
    3
    5
    8
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    periarthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    polyarthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    psoriatic arthropathy
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    2 / 448 (0.45%)
    2 / 904 (0.22%)
    1 / 19 (5.26%)
    3 / 437 (0.69%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    2
    2
    1
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rotator cuff syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    spinal osteoarthritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    spinal pain
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    1
    0
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    synovial cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    synovitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tendonitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tenosynovitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    4
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tenosynovitis stenosans
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    trigger finger
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Infections and infestations
    abdominal hernia infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abscess jaw
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    abscess limb
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    acarodermatitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    anal abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    asymptomatic bacteriuria
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    bacterial vaginosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    body tinea
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    1
    2
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    bronchitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    4 / 448 (0.89%)
    14 / 904 (1.55%)
    0 / 19 (0.00%)
    8 / 437 (1.83%)
    9 / 434 (2.07%)
    9 / 443 (2.03%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    4
    14
    0
    8
    10
    9
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    bronchitis viral
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    candida infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cellulitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    5
    0
    3
    2
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    chronic sinusitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    conjunctivitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    8 / 437 (1.83%)
    4 / 434 (0.92%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    3
    0
    9
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    cystitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    3 / 434 (0.69%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    4
    0
    2
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    demodicidosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dermatophytosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    diverticulitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    3
    0
    4
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    ear infection bacterial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    empyema
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    enteritis infectious
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    epididymitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erysipelas
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erythema infectiosum
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    erythrasma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    eye infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    folliculitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 448 (0.45%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    6 / 437 (1.37%)
    4 / 434 (0.92%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    3
    3
    0
    6
    4
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    fungal infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    fungal skin infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    furuncle
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    1 / 434 (0.23%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    6
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastroenteritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    2 / 112 (1.79%)
    3 / 448 (0.67%)
    11 / 904 (1.22%)
    1 / 19 (5.26%)
    10 / 437 (2.29%)
    9 / 434 (2.07%)
    7 / 443 (1.58%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    2
    3
    11
    1
    10
    9
    7
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastroenteritis viral
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    2 / 448 (0.45%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    4 / 434 (0.92%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    2
    5
    0
    3
    4
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gastrointestinal infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    1
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    genital candidiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    genital herpes simplex
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    genital infection female
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gingivitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    groin infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    helicobacter gastritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    3 / 434 (0.69%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    helicobacter infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    herpes simplex
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    herpes zoster
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    1 / 29 (3.45%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    3
    0
    2
    2
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    hordeolum
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    1
    0
    2
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    impetigo
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    infected dermal cyst
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    influenza
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    7 / 448 (1.56%)
    10 / 904 (1.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    5 / 434 (1.15%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    7
    10
    0
    3
    5
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    kidney infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    labyrinthitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    laryngitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    localised infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    lyme disease
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mastitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    mastoiditis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    molluscum contagiosum
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    mycoplasma infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    myringitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    nasopharyngitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    18 / 112 (16.07%)
    55 / 448 (12.28%)
    144 / 904 (15.93%)
    4 / 19 (21.05%)
    61 / 437 (13.96%)
    60 / 434 (13.82%)
    67 / 443 (15.12%)
    0 / 104 (0.00%)
    4 / 18 (22.22%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    1 / 9 (11.11%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    2 / 6 (33.33%)
    2 / 43 (4.65%)
         occurrences all number
    22
    71
    168
    5
    81
    73
    82
    0
    4
    0
    0
    1
    0
    0
    0
    0
    2
    2
    onychomycosis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oral candidiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    3
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    oral herpes
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    6 / 448 (1.34%)
    5 / 904 (0.55%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    3 / 434 (0.69%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    1 / 14 (7.14%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    6
    5
    0
    4
    5
    0
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    0
    oral fungal infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    otitis externa
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    7 / 437 (1.60%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    1 / 14 (7.14%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    1
    0
    8
    2
    2
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    otitis media acute
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    otitis media
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    1 / 19 (5.26%)
    2 / 437 (0.46%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    1 / 6 (16.67%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    1
    3
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    parasitic gastroenteritis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    paronychia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    periodontitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pharyngitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    9 / 448 (2.01%)
    7 / 904 (0.77%)
    0 / 19 (0.00%)
    13 / 437 (2.97%)
    6 / 434 (1.38%)
    4 / 443 (0.90%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    9
    7
    0
    16
    7
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pharyngitis bacterial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pharyngotonsillitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pneumonia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    postoperative wound infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pulpitis dental
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    4 / 437 (0.92%)
    2 / 434 (0.46%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    4
    2
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    pyoderma
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    respiratory tract infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    1
    0
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    rhinitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    6 / 448 (1.34%)
    16 / 904 (1.77%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    5 / 434 (1.15%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    6
    16
    0
    2
    6
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sinusitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    4 / 448 (0.89%)
    11 / 904 (1.22%)
    0 / 19 (0.00%)
    6 / 437 (1.37%)
    7 / 434 (1.61%)
    7 / 443 (1.58%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    5
    11
    0
    6
    7
    7
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    sinusitis bacterial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin bacterial infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin candida
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    skin infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    staphylococcal abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    staphylococcal infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    staphylococcal skin infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    subcutaneous abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    syphilis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tinea infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tinea cruris
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tinea pedis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    5 / 448 (1.12%)
    7 / 904 (0.77%)
    1 / 19 (5.26%)
    3 / 437 (0.69%)
    2 / 434 (0.46%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    5
    7
    1
    3
    4
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tinea versicolour
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    3 / 434 (0.69%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    3
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tonsillitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    6 / 448 (1.34%)
    6 / 904 (0.66%)
    0 / 19 (0.00%)
    8 / 437 (1.83%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    6
    8
    0
    8
    2
    4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tonsillitis bacterial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth abscess
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    0
    1
    0
    3
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    tooth infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    upper respiratory tract infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    4 / 112 (3.57%)
    39 / 448 (8.71%)
    53 / 904 (5.86%)
    1 / 19 (5.26%)
    35 / 437 (8.01%)
    30 / 434 (6.91%)
    29 / 443 (6.55%)
    0 / 104 (0.00%)
    1 / 18 (5.56%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    1 / 35 (2.86%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    5
    46
    64
    2
    46
    40
    36
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    upper respiratory tract infection bacterial
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    urinary tract infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    6 / 448 (1.34%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    5 / 437 (1.14%)
    3 / 434 (0.69%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    6
    1
    0
    5
    3
    6
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vaginal infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    viral infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    viral pharyngitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    viral sinusitis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    9 / 904 (1.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    3 / 434 (0.69%)
    5 / 443 (1.13%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    9
    0
    1
    3
    5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    4
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vulvovaginal mycotic infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    2 / 448 (0.45%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    2
    0
    0
    2
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    wound infection
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Metabolism and nutrition disorders
    cachexia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    decreased appetite
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    2
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    diabetes mellitus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    3 / 448 (0.67%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    2 / 434 (0.46%)
    3 / 443 (0.68%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    2
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    dyslipidaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    food craving
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    gout
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypercholesterolaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    3
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyperglycaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    1 / 112 (0.89%)
    3 / 448 (0.67%)
    3 / 904 (0.33%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    1
    3
    3
    0
    1
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyperlipidaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    2 / 904 (0.22%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    2
    0
    3
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypertriglyceridaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    4 / 904 (0.44%)
    0 / 19 (0.00%)
    2 / 437 (0.46%)
    1 / 434 (0.23%)
    2 / 443 (0.45%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    5
    0
    2
    1
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hyperuricaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    3 / 437 (0.69%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypocholesterolaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    hypokalaemia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    increased appetite
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    1 / 443 (0.23%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    iron deficiency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    metabolic syndrome
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    obesity
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    1 / 434 (0.23%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    polydipsia
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    0 / 904 (0.00%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    1 / 448 (0.22%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    1 / 437 (0.23%)
    2 / 434 (0.46%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    1
    1
    0
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    vitamin d deficiency
    alternative dictionary used: MedDRA 23.0
         subjects affected / exposed
    0 / 112 (0.00%)
    0 / 448 (0.00%)
    1 / 904 (0.11%)
    0 / 19 (0.00%)
    0 / 437 (0.00%)
    0 / 434 (0.00%)
    0 / 443 (0.00%)
    0 / 104 (0.00%)
    0 / 18 (0.00%)
    0 / 4 (0.00%)
    0 / 4 (0.00%)
    0 / 9 (0.00%)
    0 / 1 (0.00%)
    0 / 29 (0.00%)
    0 / 14 (0.00%)
    0 / 35 (0.00%)
    0 / 6 (0.00%)
    0 / 43 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    08 Feb 2019
    Revised major secondary endpoint so that DLQI (0,1) response will include a 5-point reduction and be assessed in patients with baseline DLQI 5 (also included this endpoint at other times as Other Secondary endpoints). Changed PPASI, PSSI, and NAPSI endpoints from “percent change” to “change.”
    30 Sep 2019
    Added endpoint of proportion of patients achieving PASI 100 at Week 52 for superiority objective.

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

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

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