Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A randomized, double-blind, multicenter study to assess the efficacy and safety of 16 weeks secukinumab dosage interval shortening in comparison to continued standard treatment (4-weekly 300 mg s.c.) in patients with moderate-severe plaque type psoriasis who achieved less than almost clear skin after 16 weeks under the standard dose of secukinumab Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.

    Summary
    EudraCT number
    		 2014-001974-32
    Trial protocol
    		 DE  
    Global end of trial date
    15 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jul 2018
    First version publication date
    07 Jul 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AIN457ADE04
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02474069
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    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
    15 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to demonstrate that 300 mg secukinumab administered every 2 weeks was superior in achieving PASI 90 at Week 32 compared to 300 mg secukinumab every 4 weeks in patients who, after treatment with the standard dose, had less than almost clear skin (PASI ≥ 75 to PASI < 90) at Week 16.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 May 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 772
    Worldwide total number of subjects
    772
    EEA total number of subjects
    772
    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)
    712
    From 65 to 84 years
    59
    85 years and over
    1

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 860 were screened (not shown here). In selection phase (SP), 772 received 300 mg s.c. open-label secukinumab at baseline, to week 12. Those who did not achieve at least PASI 75 at week 16 discontinued. Those who had less than clear or almost clear skin (at least PASI 75 but not PASI 90) rolled over into double blind comparative dosing phase (CDP)

    Pre-assignment
    Screening details
    		 and randomized 1:1 to: a.standard treatment: 300 mg s.c. secukinumab treatment every 4 weeks (weeks 16, 20, 24, & 28) and, to maintain the blind, placebo every 4 weeks b. OR dosage interval shortening: 300 mg s.c. secukinumab treatment every 2 weeks. Those who achieved at least clear or almost clear skin (≥ PASI 90) at week 16 discontinued study

    Period 1
    Period 1 title
    Overall: Selection->CDP (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 SP - Secukinumab 300 mg s.c. (4-weekly)
    Arm description
    		 In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

    Arm title
    		 CDP - Secukinumab 300 mg s.c. (4-weekly)
    Arm description
    		 In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).

    Arm title
    		 CDP - Secukinumab 300 mg s.c. (2-weekly)
    Arm description
    		 In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

    Number of subjects in period 1
    		SP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Started
    772
    162
    163
    Completed
    749
    153
    157
    Not completed
    23
    9
    6
         Consent withdrawn by subject
    3
    2
    3
         Physician decision
    1
    -
    -
         Withdrawal of informed Consent
    3
    -
    -
         Adverse event, non-fatal
    8
    3
    2
         Technical Problem
    1
    -
    -
         Lost to follow-up
    4
    4
    1
         No longer requires treatment
    1
    -
    -
         Lack of efficacy
    1
    -
    -
         Protocol deviation
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall: Selection->CDP
    Reporting group description
    		 -

    Reporting group values
    		 Overall: Selection->CDP Total
    Number of subjects
    		 772 772
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 712 712
        From 65-84 years
    		 59 59
        85 years and over
    		 1 1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 45.8 ± 13.72 -
    Gender Categorical
    Comparative dosing phase (CDP) only
    Units: Subjects
        Female
    		 222 222
        Male
    		 550 550
    Subject analysis sets

    Subject analysis set title
    SP - Secukinumab 300 mg s.c. (4-weekly
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16

    Subject analysis sets values
    		 SP - Secukinumab 300 mg s.c. (4-weekly
    Number of subjects
    772
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    712
        From 65-84 years
    59
        85 years and over
    1
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    45.8 ± 13.72
    Gender Categorical
    Comparative dosing phase (CDP) only
    Units: Subjects
        Female
    222
        Male
    550

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    SP - Secukinumab 300 mg s.c. (4-weekly)
    Reporting group description
    		 In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12.

    Reporting group title
    CDP - Secukinumab 300 mg s.c. (4-weekly)
    Reporting group description
    		 In the CDP, patients received 300 mg s.c. secukinumab treatment every 4 weeks (Week 16, 20, 24, and 28) and placebo every 4 weeks (at Week 18, 22, 26 and 30).

    Reporting group title
    CDP - Secukinumab 300 mg s.c. (2-weekly)
    Reporting group description
    		 In the CDP, patients received 300 mg s.c. secukinumab treatment every 2 weeks (at weeks 16, 18, 20, 22, 24, 26, 28 and 30)

    Subject analysis set title
    SP - Secukinumab 300 mg s.c. (4-weekly
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    In the SP, all patients were treated with open-label secukinumab 300 mg s.c. at baseline, Weeks 1, 2, 3, 4, 8, and 12. At Week 16

    Primary: Number of participants with PASI 90 response at Week 32

    		 Close Top of page
    End point title
    		 Number of participants with PASI 90 response at Week 32 [1]
    End point description
    Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Primary
    End point timeframe
    at 32 weeks
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: participants
    93
    105
    Statistical analysis title
    		 Number of participants with PASI 90 resposne
    Statistical analysis description
    Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error
    Comparison groups
    CDP - Secukinumab 300 mg s.c. (4-weekly) v CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects included in analysis
    325
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.087
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.39
         upper limit
    		 1.07

    Primary: Number of participants with PASI 90 response at Week 32 for PPS

    		 Close Top of page
    End point title
    		 Number of participants with PASI 90 response at Week 32 for PPS [2]
    End point description
    Number of participants with at least 90% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Primary
    End point timeframe
    at week 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    136
    134
    Units: participants
    81
    85
    Statistical analysis title
    		 Number of participants with PASI 90 response
    Statistical analysis description
    Logistic regression model: Logit (proportion) = treatment + PASI Score at baseline + PASI score at randomization + error
    Comparison groups
    CDP - Secukinumab 300 mg s.c. (2-weekly) v CDP - Secukinumab 300 mg s.c. (4-weekly)
    Number of subjects included in analysis
    270
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.281
    Method
    		 ANCOVA
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 1.28

    Secondary: Selection Phase: Number of participants achieving (Psoriasis Area and Severity Index score)PASI 50, 75, 90, 100

    		 Close Top of page
    End point title
    		 Selection Phase: Number of participants achieving (Psoriasis Area and Severity Index score)PASI 50, 75, 90, 100 [3]
    End point description
    Number of participants with at least 50, 75, 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    at weeks 1, 2, 3, 4, 8, 12 and 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: Statistics do not apply to this end point.
    End point values
    		 SP - Secukinumab 300 mg s.c. (4-weekly)
    Number of subjects analysed
    772
    Units: Number of participants
        Week 1, PASI 50 (n= 768)
    43
        Week 1, PASI 75 (n= 768)
    3
        Week 1, PASI 90 (n= 768)
    0
        Week 1, PASI 100 (n= 768)
    0
        Week 2, PASI 50 (n= 766)
    232
        week 2, PASI 75 (n= 766)
    25
        Week 2, PASI 90 (n= 766)
    5
        Week 2, PASI 100 (n= 766)
    1
        Week 3, PASI 50 (n= 766)
    468
        Week 3, PASI 75 (n= 766)
    128
        Week 3, PASI 90 (n= 766)
    22
        Week 3, PASI 100 (n= 766)
    3
        Week 4, PASI 50 (n= 768)
    591
        Week 4, PASI 75 (n= 768)
    281
        Week 4, PASI 90 (n= 768)
    71
        Week 4, PASI 100 (n= 768)
    12
        Week 8, PASI 50 (n= 762)
    718
        Week 8, PASI 75 (n= 762)
    538
        Week 8, PASI 90 (n= 762)
    266
        Week 8, PASI 100 (n= 762)
    70
        Week 12, PASI 50 (n= 761)
    733
        Week 12, PASI 75 (n= 761)
    611
        Week 12, PASI 90 (n= 761)
    370
        Week 12, PASI 100 (n= 761)
    110
        Week 16, PASI 50 (n= 753)
    732
        Week 16, PASI 75 (n= 753)
    698
        Week 16, PASI 90 (n= 753)
    363
        Week 16, PASI 100 (n= 753)
    124
    No statistical analyses for this end point

    Secondary: Comparative Dose Phase: Number of participants achieving (Psoriasis Area and Severity Index score)PASI 50, 75, 90, 100

    		 Close Top of page
    End point title
    		 Comparative Dose Phase: Number of participants achieving (Psoriasis Area and Severity Index score)PASI 50, 75, 90, 100 [4]
    End point description
    Number of participants with at least 50, 75, 90 or 100% improvement from baseline. PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    at weeks 18, 22, 30, 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: Number of participants
        Week 18, PASI 90 (n=162, 163)
    42
    36
        Week 18, PASI 100 (n=162, 163)
    1
    1
        Week 22, PASI 90 (n=162, 163)
    70
    67
        Week 22, PASI 100 (n=162, 163)
    9
    9
        Week 26, PASI 90 (n=162, 163)
    85
    94
        Week 26, PASI 100 (n=162, 163)
    9
    14
        Week 30, PASI 90 (n=162, 163)
    93
    104
        Week 30, PASI 100 (n=162, 163)
    17
    19
        Week 32, PASI 90 (n=162,163)
    93
    105
        Week 32, PASI 100 (n=162, 163)
    22
    26
    No statistical analyses for this end point

    Secondary: Selection Phase:Summary of PASI total score

    		 Close Top of page
    End point title
    		 Selection Phase:Summary of PASI total score [5]
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    at weeks 1,2,3,4,8, 12, 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: Statistics do not apply to this end point.
    End point values
    		 SP - Secukinumab 300 mg s.c. (4-weekly)
    Number of subjects analysed
    772
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        week 1 (n=768)
    18.78 ± 9.629
        week 2(n=766)
    14.32 ± 8.435
        week 3(n=766)
    10.69 ± 7.372
        week 4(n=768)
    8.12 ± 6.494
        week 8(n=762)
    4.41 ± 4.544
        Week 12 (n=761)
    3.34 ± 3.833
        Week 16 (n=753)
    2.9 ± 3.816
    No statistical analyses for this end point

    Secondary: Comparative Dose Phase: Summary of PASI total score

    		 Close Top of page
    End point title
    		 Comparative Dose Phase: Summary of PASI total score [6]
    End point description
    PASI is a combined assessment of lesion severity and affected area into a single score: 0 (no disease) to 72 (maximal disease). Body is divided into 4 areas for scoring (head, arms, trunk, legs; each area is scored by itself and scores are combined for final PASI. For each area, percent of skin involved is estimated: 0 (0%) to 6 (90-100%), and severity is estimated by clinical signs, erythema, induration and desquamation; scale 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each area* area score weight of section (head: 0.1, arms: 0.2 body: 0.3 legs: 0.4).
    End point type
    Secondary
    End point timeframe
    Weeks 18, 22, 26, 30 and 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: Score on a Scale
    arithmetic mean (standard deviation)
        Week 18 (n=162, 163)
    3.71 ± 2.532
    3.59 ± 2.595
        Week 22 (n=161, 161)
    3.24 ± 2.947
    3.07 ± 2.726
        Week 26 (n=156, 160)
    2.85 ± 2.852
    2.68 ± 3.393
        Week 30 (n= 154, 158)
    2.83 ± 3.339
    2.34 ± 2.812
        Week 32 (n=153, 152)
    2.84 ± 3.552
    2.11 ± 2.701
    No statistical analyses for this end point

    Secondary: Number of patients achieving Dermatology Life Quality Index (DLQI)

    		 Close Top of page
    End point title
    		 Number of patients achieving Dermatology Life Quality Index (DLQI) [7]
    End point description
    The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: participants
        Week 4 (n=160, NA)
    13
    9999
        Week 16
    62
    9999
        Week 18
    65
    58
        Week 22
    70
    73
        Week 26
    69
    83
        Week 30
    75
    89
        Week 32
    82
    96
    No statistical analyses for this end point

    Secondary: Number of Patients achieving DLQI total score <= 5

    		 Close Top of page
    End point title
    		 Number of Patients achieving DLQI total score <= 5 [8]
    End point description
    The DLQI is a ten item general dermatology disability index designed to assess health-related quality of life in adult participants with skin diseases such as eczema, psoriasis, acne and viral worts. It is a self-administered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is a valid score also and is scored as 0. The DLQI total score is a sum of all 10 responses. Scores range from 0 to 30 with higher scores indicating greater health-related quality of life impairment.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 16, 18, 22, 26, 30, 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: participants
        Week 4 (n=160, NA)
    53
    9999
        Week 16
    113
    9999
        Week 18
    109
    108
        Week 22
    112
    117
        Week 26
    116
    121
        Week 30
    114
    127
        Week 32
    117
    126
    No statistical analyses for this end point

    Secondary: Selection Phase: Number of patients achieving Investigator global assessment (IGA) 0 or 1

    		 Close Top of page
    End point title
    		 Selection Phase: Number of patients achieving Investigator global assessment (IGA) 0 or 1 [9]
    End point description
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 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: Statistics do not apply to this end point.
    End point values
    		 SP - Secukinumab 300 mg s.c. (4-weekly)
    Number of subjects analysed
    772
    Units: Participants
        week 4 (n=768)
    150
        week 16 (n=759)
    446
    No statistical analyses for this end point

    Secondary: Comparative Dose Phase: Number of patients achieving Investigator global assessment (IGA) 0 or 1

    		 Close Top of page
    End point title
    		 Comparative Dose Phase: Number of patients achieving Investigator global assessment (IGA) 0 or 1 [10]
    End point description
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
    End point type
    Secondary
    End point timeframe
    Weeks 18, 22, 26, 30, 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: Participants
        week 18 (n=162, 163)
    67
    68
        week 22 (n=161, 161)
    88
    90
        week 26 (n= 156, 160)
    87
    111
        week 30 (n=154, 158)
    97
    106
        week 32 (n=153, 152)
    98
    111
    No statistical analyses for this end point

    Secondary: Selection Phase: Summary of IGA Score

    		 Close Top of page
    End point title
    		 Selection Phase: Summary of IGA Score [11]
    End point description
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
    End point type
    Secondary
    End point timeframe
    Weeks 4, 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: Statistics do not apply to this end point.
    End point values
    		 SP - Secukinumab 300 mg s.c. (4-weekly)
    Number of subjects analysed
    772
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 4 (n=768)
    2.1 ± 0.79
        Week 16 (n=759)
    1.26 ± 0.875
    No statistical analyses for this end point

    Secondary: Comparative Dose Phase:Summary of IGA Score

    		 Close Top of page
    End point title
    		 Comparative Dose Phase:Summary of IGA Score [12]
    End point description
    The IGA scale is static, i.e. it referred exclusively to the participant's disease at the time of the assessment, and did not compare with any of the participant's previous disease states at previous visits. The scores are: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 = very severe.
    End point type
    Secondary
    End point timeframe
    Weeks 18, 22, 26, 30, 32
    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: Statistics do not apply to this end point.
    End point values
    		 CDP - Secukinumab 300 mg s.c. (4-weekly) CDP - Secukinumab 300 mg s.c. (2-weekly)
    Number of subjects analysed
    162
    163
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 18 (n=162, 163)
    1.63 ± 0.619
    1.64 ± 0.656
        Week 22 (n= 161, 161)
    1.46 ± 0.733
    1.42 ± 0.704
        Week 26 (n=156, 160)
    1.48 ± 0.758
    1.3 ± 0.759
        Week 30 (n= 154, 158)
    1.33 ± 0.848
    1.27 ± 0.803
        Week 32 (n=153, 152)
    1.3 ± 0.925
    1.13 ± 0.819
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Selection Phase: AIN457 300 mg s.c. (4-weekly)
    Reporting group description
    		 Selection Phase: AIN457 300 mg s.c. (4-weekly)

    Reporting group title
    Comparative Dosing Phase: AIN457 300 mg s.c. (4-weekly)
    Reporting group description
    		 Comparative Dosing Phase: AIN457 300 mg s.c. (4-weekly)

    Reporting group title
    Comparative Dosing Phase: AIN457 300 mg s.c. (2-weekly)
    Reporting group description
    		 Comparative Dosing Phase: AIN457 300 mg s.c. (2-weekly)

    Serious adverse events
    		 Selection Phase: AIN457 300 mg s.c. (4-weekly) Comparative Dosing Phase: AIN457 300 mg s.c. (4-weekly) Comparative Dosing Phase: AIN457 300 mg s.c. (2-weekly)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    32 / 772 (4.15%)
    8 / 162 (4.94%)
    4 / 163 (2.45%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    B-CELL LYMPHOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    BASAL CELL CARCINOMA
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYCOSIS FUNGOIDES
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PANCREATIC CARCINOMA
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    HAEMORRHAGE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERTENSIVE CRISIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    CHEST PAIN
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHILLS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    IMPAIRED HEALING
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA EXERCISE INDUCED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HYPERVENTILATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    MANIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PANIC ATTACK
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    CHEST INJURY
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CONCUSSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CONTUSION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    FEMUR FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    LIGAMENT RUPTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RADIAL HEAD DISLOCATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RADIUS FRACTURE
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    STERNAL FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TENDON RUPTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    WOUND
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MYOCARDITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    INTERCOSTAL NEURALGIA
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    COLITIS ULCERATIVE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    UMBILICAL HERNIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    BILIARY COLIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    CHOLECYSTITIS CHRONIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    ACROKERATOSIS PARANEOPLASTICA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    DERMATITIS EXFOLIATIVE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SKIN ULCER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    FIBRILLARY GLOMERULONEPHRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    RENAL CYST HAEMORRHAGE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    URETEROLITHIASIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    ERYSIPELAS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    MASTOIDITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    PYODERMA
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    SINUSITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VARICELLA
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPERGLYCAEMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Selection Phase: AIN457 300 mg s.c. (4-weekly) Comparative Dosing Phase: AIN457 300 mg s.c. (4-weekly) Comparative Dosing Phase: AIN457 300 mg s.c. (2-weekly)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    510 / 772 (66.06%)
    85 / 162 (52.47%)
    87 / 163 (53.37%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    BASAL CELL CARCINOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DYSPLASTIC NAEVUS
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    FIBROMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FIBROUS HISTIOCYTOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MELANOCYTIC NAEVUS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MONOCLONAL GAMMOPATHY
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    SEBORRHOEIC KERATOSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SKIN PAPILLOMA
         subjects affected / exposed
    9 / 772 (1.17%)
    3 / 162 (1.85%)
    1 / 163 (0.61%)
         occurrences all number
    9
    3
    1
    Vascular disorders
    DIASTOLIC HYPERTENSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FLUSHING
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMATOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    1
    1
    1
    HAEMORRHAGE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERTENSION
         subjects affected / exposed
    8 / 772 (1.04%)
    3 / 162 (1.85%)
    4 / 163 (2.45%)
         occurrences all number
    8
    3
    4
    LYMPHOEDEMA
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    PERIPHERAL VENOUS DISEASE
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    VARICOSE VEIN
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    APPLICATION SITE HAEMATOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ASTHENIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    CHILLS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DRUG THERAPEUTIC INCOMPATIBILITY
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    FATIGUE
         subjects affected / exposed
    28 / 772 (3.63%)
    4 / 162 (2.47%)
    3 / 163 (1.84%)
         occurrences all number
    46
    4
    6
    FEELING HOT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    IMPAIRED HEALING
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INFLUENZA LIKE ILLNESS
         subjects affected / exposed
    10 / 772 (1.30%)
    2 / 162 (1.23%)
    1 / 163 (0.61%)
         occurrences all number
    13
    2
    1
    INJECTION SITE BRUISING
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    INJECTION SITE ERYTHEMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INJECTION SITE HAEMATOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INJECTION SITE HAEMORRHAGE
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    INJECTION SITE PAIN
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    4
    0
    1
    INJECTION SITE PRURITUS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    INJURY ASSOCIATED WITH DEVICE
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    OEDEMA PERIPHERAL
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    5
    0
    0
    PERIPHERAL SWELLING
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    PUNCTURE SITE REACTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PYREXIA
         subjects affected / exposed
    9 / 772 (1.17%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    10
    0
    0
    SENSATION OF FOREIGN BODY
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    THIRST
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    SEASONAL ALLERGY
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    Reproductive system and breast disorders
    BALANOPOSTHITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    BREAST CYST
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DYSMENORRHOEA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MENOPAUSAL SYMPTOMS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MENSTRUATION IRREGULAR
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    METRORRHAGIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PROSTATITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    PRURITUS GENITAL
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    12 / 772 (1.55%)
    0 / 162 (0.00%)
    2 / 163 (1.23%)
         occurrences all number
    13
    0
    2
    DYSPHONIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DYSPNOEA
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    EPISTAXIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    3
    0
    NASAL CONGESTION
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    3
    1
    0
    NASAL INFLAMMATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NASAL MUCOSAL EROSION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    OROPHARYNGEAL DISCOMFORT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    12 / 772 (1.55%)
    1 / 162 (0.62%)
    2 / 163 (1.23%)
         occurrences all number
    12
    1
    2
    PHARYNGEAL INFLAMMATION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    PRODUCTIVE COUGH
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    RHINITIS ALLERGIC
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    RHINORRHOEA
         subjects affected / exposed
    10 / 772 (1.30%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    11
    1
    0
    SLEEP APNOEA SYNDROME
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    THROAT IRRITATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    ALCOHOL ABUSE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DEPRESSION
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    INITIAL INSOMNIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INSOMNIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MOOD SWINGS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NERVOUSNESS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SLEEP DISORDER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    3
    1
    1
    ASPARTATE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    BILIRUBIN URINE PRESENT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    BLOOD CHOLESTEROL INCREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    BLOOD TRIGLYCERIDES INCREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    BLOOD URINE PRESENT
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ELECTROCARDIOGRAM ABNORMAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    ELECTROCARDIOGRAM Q WAVE ABNORMAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    HIGH DENSITY LIPOPROTEIN DECREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    HUMAN CHORIONIC GONADOTROPIN INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LIVER FUNCTION TEST INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MONOCYTE COUNT INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NEUTROPHIL COUNT DECREASED
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    PLATELET COUNT DECREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TRANSAMINASES INCREASED
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    WEIGHT INCREASED
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    Injury, poisoning and procedural complications
    ACCIDENT AT WORK
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ANIMAL BITE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    ARTHROPOD BITE
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    ARTHROPOD STING
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    BURN ORAL CAVITY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CONTUSION
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    5
    0
    0
    CRANIOCEREBRAL INJURY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FALL
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    FOREIGN BODY IN EYE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    3
    0
    1
    HAND FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    JOINT DISLOCATION
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    JOINT INJURY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LACERATION
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    LIGAMENT RUPTURE
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    LIGAMENT SPRAIN
         subjects affected / exposed
    6 / 772 (0.78%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    6
    0
    0
    LIMB INJURY
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    MENISCUS INJURY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MUSCLE STRAIN
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    PLAQUE SHIFT
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    PROCEDURAL DIZZINESS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PROCEDURAL PAIN
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    3
    1
    1
    RIB FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SKIN ABRASION
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    SUBCUTANEOUS HAEMATOMA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    SUNBURN
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    TENDON RUPTURE
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    THERMAL BURN
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TOOTH FRACTURE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    WOUND
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    Congenital, familial and genetic disorders
    CONGENITAL NAEVUS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    0
    1
    1
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    BUNDLE BRANCH BLOCK LEFT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SINUS ARRHYTHMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TACHYCARDIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    BURNING SENSATION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    CARPAL TUNNEL SYNDROME
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    CERVICOGENIC VERTIGO
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    DIZZINESS
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    3
    1
    0
    DYSAESTHESIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DYSGEUSIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    HEADACHE
         subjects affected / exposed
    60 / 772 (7.77%)
    5 / 162 (3.09%)
    5 / 163 (3.07%)
         occurrences all number
    88
    7
    8
    HYPERAESTHESIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MIGRAINE
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    NERVE COMPRESSION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    NEURALGIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    NEURITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ORTHOSTATIC INTOLERANCE
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    SCIATICA
         subjects affected / exposed
    4 / 772 (0.52%)
    1 / 162 (0.62%)
    4 / 163 (2.45%)
         occurrences all number
    4
    1
    4
    SOMNOLENCE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    LEUKOCYTOSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LYMPHADENOPATHY
         subjects affected / exposed
    2 / 772 (0.26%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    2
    2
    0
    LYMPHOPENIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NEUTROPENIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    THROMBOCYTOPENIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    Ear and labyrinth disorders
    EAR PAIN
         subjects affected / exposed
    1 / 772 (0.13%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    1
    2
    0
    EAR PRURITUS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    HYPOACUSIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    SUDDEN HEARING LOSS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TINNITUS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    TYMPANIC MEMBRANE PERFORATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    VERTIGO
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    Eye disorders
    BLEPHARITIS
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    3
    1
    0
    CATARACT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CHALAZION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    CONJUNCTIVAL HYPERAEMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CONJUNCTIVITIS ALLERGIC
         subjects affected / exposed
    4 / 772 (0.52%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    4
    1
    1
    DRY EYE
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    3
    0
    1
    ECZEMA EYELIDS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    EYE IRRITATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    EYE PAIN
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    EYE SWELLING
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    EYELID OEDEMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    EYELIDS PRURITUS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INTRAOCULAR HAEMATOMA
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    KERATITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LACRIMATION INCREASED
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    0
    VISUAL IMPAIRMENT
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    Gastrointestinal disorders
    ABDOMINAL DISTENSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ABDOMINAL PAIN
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    17 / 772 (2.20%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    19
    1
    1
    ANAL SKIN TAGS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ANORECTAL DISCOMFORT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    APHTHOUS ULCER
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    COLITIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    COLITIS MICROSCOPIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CONSTIPATION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    DENTAL CARIES
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DIARRHOEA
         subjects affected / exposed
    34 / 772 (4.40%)
    3 / 162 (1.85%)
    1 / 163 (0.61%)
         occurrences all number
    41
    3
    2
    DRY MOUTH
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    0
    DYSPEPSIA
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    DYSPHAGIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    EPULIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FAECES SOFT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FLATULENCE
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    FREQUENT BOWEL MOVEMENTS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    GASTRITIS
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    5
    0
    1
    GASTRITIS EROSIVE
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    GASTROINTESTINAL PAIN
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    6 / 772 (0.78%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    6
    0
    1
    GINGIVAL DISORDER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GINGIVAL EROSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMORRHOIDS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPOAESTHESIA ORAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INTRA-ABDOMINAL HAEMATOMA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LARGE INTESTINE POLYP
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LIP BLISTER
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    LIP DRY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MALLORY-WEISS SYNDROME
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MOUTH SWELLING
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MOUTH ULCERATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NAUSEA
         subjects affected / exposed
    9 / 772 (1.17%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    9
    1
    0
    PARAESTHESIA ORAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    POUCHITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TONGUE COATED
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    0
    TONGUE DISCOLOURATION
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    TOOTHACHE
         subjects affected / exposed
    9 / 772 (1.17%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    10
    0
    0
    VASCULITIS GASTROINTESTINAL
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    VOMITING
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    3
    1
    1
    Hepatobiliary disorders
    BILIARY COLIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CHOLECYSTITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    CHOLELITHIASIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HEPATIC STEATOSIS
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    HYPERBILIRUBINAEMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    Skin and subcutaneous tissue disorders
    ACNE
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    ACTINIC KERATOSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ALOPECIA
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    5
    0
    0
    ALOPECIA AREATA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    BLISTER
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    BLOOD BLISTER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DERMAL CYST
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    DERMATITIS ALLERGIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    DERMATITIS CONTACT
         subjects affected / exposed
    5 / 772 (0.65%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    5
    2
    0
    DRUG ERUPTION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    DRY SKIN
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    DYSHIDROTIC ECZEMA
         subjects affected / exposed
    3 / 772 (0.39%)
    2 / 162 (1.23%)
    2 / 163 (1.23%)
         occurrences all number
    4
    2
    2
    ECZEMA
         subjects affected / exposed
    10 / 772 (1.30%)
    4 / 162 (2.47%)
    1 / 163 (0.61%)
         occurrences all number
    10
    4
    1
    ECZEMA WEEPING
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ERYTHEMA
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    ERYTHEMA NODOSUM
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERHIDROSIS
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    INGROWING NAIL
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    INTERTRIGO
         subjects affected / exposed
    8 / 772 (1.04%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    9
    0
    1
    MILIARIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MYXOID CYST
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    PAIN OF SKIN
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PAPULE
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    PETECHIAE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PHOTODERMATOSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PHOTOSENSITIVITY REACTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PRURIGO
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PRURITUS
         subjects affected / exposed
    32 / 772 (4.15%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    34
    2
    0
    PRURITUS ALLERGIC
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PRURITUS GENERALISED
         subjects affected / exposed
    8 / 772 (1.04%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    9
    1
    1
    PSORIASIS
         subjects affected / exposed
    3 / 772 (0.39%)
    2 / 162 (1.23%)
    2 / 163 (1.23%)
         occurrences all number
    3
    2
    2
    PUSTULAR PSORIASIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    RASH
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    RASH MACULAR
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    RASH PAPULAR
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ROSACEA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    SEBORRHOEA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SEBORRHOEIC DERMATITIS
         subjects affected / exposed
    13 / 772 (1.68%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    14
    0
    1
    SKIN ATROPHY
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    SKIN EXFOLIATION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    SKIN FISSURES
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    SKIN IRRITATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    SKIN PLAQUE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SKIN ULCER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SKIN ULCER HAEMORRHAGE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SOLAR DERMATITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    URTICARIA
         subjects affected / exposed
    7 / 772 (0.91%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    7
    1
    1
    Renal and urinary disorders
    DYSURIA
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    HAEMATURIA
         subjects affected / exposed
    5 / 772 (0.65%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    5
    1
    0
    LEUKOCYTURIA
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    0
    NEPHROLITHIASIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    POLLAKIURIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    PROTEINURIA
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    Endocrine disorders
    HYPERTHYROIDISM
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPOTHYROIDISM
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    THYROID CYST
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    21 / 772 (2.72%)
    4 / 162 (2.47%)
    3 / 163 (1.84%)
         occurrences all number
    23
    5
    3
    ARTHRITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    BACK PAIN
         subjects affected / exposed
    9 / 772 (1.17%)
    3 / 162 (1.85%)
    3 / 163 (1.84%)
         occurrences all number
    11
    3
    3
    BURSITIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    FIBROMYALGIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FLANK PAIN
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    JOINT CREPITATION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    JOINT EFFUSION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    JOINT SWELLING
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    4
    0
    0
    METATARSALGIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MUSCLE SPASMS
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    MUSCLE TIGHTNESS
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    3
    0
    1
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    MYALGIA
         subjects affected / exposed
    4 / 772 (0.52%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    4
    2
    0
    NECK PAIN
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    2 / 163 (1.23%)
         occurrences all number
    1
    1
    2
    PAIN IN EXTREMITY
         subjects affected / exposed
    12 / 772 (1.55%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    13
    0
    0
    PATELLOFEMORAL PAIN SYNDROME
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PSORIATIC ARTHROPATHY
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    RHEUMATIC DISORDER
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SCOLIOSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SPINAL PAIN
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SYNOVIAL CYST
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    TENDONITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    TENOSYNOVITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    ABDOMINAL ABSCESS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ABSCESS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ANGULAR CHEILITIS
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    6
    0
    2
    BACTERIAL INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    BACTERIAL RHINITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    BACTERIAL VAGINOSIS
         subjects affected / exposed
    0 / 772 (0.00%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    0
    2
    0
    BALANITIS CANDIDA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    BODY TINEA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    BRONCHITIS
         subjects affected / exposed
    10 / 772 (1.30%)
    2 / 162 (1.23%)
    2 / 163 (1.23%)
         occurrences all number
    12
    2
    2
    BRONCHITIS BACTERIAL
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    BRONCHITIS VIRAL
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    CANDIDA INFECTION
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    5
    0
    0
    CONJUNCTIVITIS
         subjects affected / exposed
    8 / 772 (1.04%)
    1 / 162 (0.62%)
    2 / 163 (1.23%)
         occurrences all number
    8
    1
    2
    CONJUNCTIVITIS BACTERIAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    CYSTITIS
         subjects affected / exposed
    4 / 772 (0.52%)
    2 / 162 (1.23%)
    1 / 163 (0.61%)
         occurrences all number
    4
    2
    1
    CYSTITIS BACTERIAL
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    2
    ECZEMA IMPETIGINOUS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    EPIDIDYMITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    EPIGLOTTITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ERYSIPELAS
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    FOLLICULITIS
         subjects affected / exposed
    13 / 772 (1.68%)
    4 / 162 (2.47%)
    2 / 163 (1.23%)
         occurrences all number
    13
    4
    2
    FUNGAL INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    FUNGAL SKIN INFECTION
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    5
    0
    0
    FURUNCLE
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    GASTROENTERITIS
         subjects affected / exposed
    7 / 772 (0.91%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    7
    1
    0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    8 / 772 (1.04%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    8
    1
    1
    GASTROINTESTINAL VIRAL INFECTION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    GENITAL CANDIDIASIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GENITAL INFECTION FUNGAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GINGIVITIS
         subjects affected / exposed
    4 / 772 (0.52%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    4
    1
    0
    HELICOBACTER INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HERPES SIMPLEX
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    HERPES VIRUS INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HERPES ZOSTER
         subjects affected / exposed
    2 / 772 (0.26%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    2
    2
    0
    HERPES ZOSTER INFECTION NEUROLOGICAL
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    HORDEOLUM
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    IMPETIGO
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    INFLUENZA
         subjects affected / exposed
    9 / 772 (1.17%)
    2 / 162 (1.23%)
    2 / 163 (1.23%)
         occurrences all number
    9
    2
    3
    LABYRINTHITIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    LARYNGITIS
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    LOCALISED INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    LYME DISEASE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    MUCOSAL INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NAIL BED INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    168 / 772 (21.76%)
    23 / 162 (14.20%)
    27 / 163 (16.56%)
         occurrences all number
    204
    26
    30
    OESOPHAGEAL CANDIDIASIS
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    ORAL CANDIDIASIS
         subjects affected / exposed
    14 / 772 (1.81%)
    2 / 162 (1.23%)
    3 / 163 (1.84%)
         occurrences all number
    14
    2
    3
    ORAL FUNGAL INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    2
    0
    ORAL HERPES
         subjects affected / exposed
    15 / 772 (1.94%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    19
    1
    1
    ORCHITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    OTITIS EXTERNA
         subjects affected / exposed
    4 / 772 (0.52%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    4
    1
    1
    OTITIS MEDIA
         subjects affected / exposed
    4 / 772 (0.52%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    4
    0
    1
    OTITIS MEDIA ACUTE
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    PARONYCHIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    PERICHONDRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PERIODONTITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    PHARYNGITIS
         subjects affected / exposed
    6 / 772 (0.78%)
    2 / 162 (1.23%)
    1 / 163 (0.61%)
         occurrences all number
    6
    3
    1
    PHARYNGITIS BACTERIAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PHARYNGITIS STREPTOCOCCAL
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    PULPITIS DENTAL
         subjects affected / exposed
    5 / 772 (0.65%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    5
    0
    1
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    RHINITIS
         subjects affected / exposed
    16 / 772 (2.07%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    16
    1
    0
    SINUSITIS
         subjects affected / exposed
    8 / 772 (1.04%)
    2 / 162 (1.23%)
    1 / 163 (0.61%)
         occurrences all number
    8
    2
    1
    SKIN CANDIDA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    1
    0
    1
    SKIN INFECTION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    2
    0
    1
    STAPHYLOCOCCAL SKIN INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    TINEA INFECTION
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    2
    0
    0
    TINEA PEDIS
         subjects affected / exposed
    8 / 772 (1.04%)
    3 / 162 (1.85%)
    1 / 163 (0.61%)
         occurrences all number
    8
    3
    1
    TONSILLITIS
         subjects affected / exposed
    6 / 772 (0.78%)
    1 / 162 (0.62%)
    2 / 163 (1.23%)
         occurrences all number
    6
    1
    2
    TONSILLITIS BACTERIAL
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    TOOTH INFECTION
         subjects affected / exposed
    2 / 772 (0.26%)
    2 / 162 (1.23%)
    0 / 163 (0.00%)
         occurrences all number
    2
    3
    0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 772 (0.39%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    3
    1
    0
    URETHRITIS
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    3
    0
    1
    VIRAL INFECTION
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    1
    1
    1
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    3
    0
    1
    VULVOVAGINAL CANDIDIASIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    VULVOVAGINAL MYCOTIC INFECTION
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    3
    1
    0
    Metabolism and nutrition disorders
    DECREASED APPETITE
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    DIABETES MELLITUS
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    1 / 163 (0.61%)
         occurrences all number
    2
    1
    1
    FLUID RETENTION
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    GOUT
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HAEMOSIDEROSIS
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERCHOLESTEROLAEMIA
         subjects affected / exposed
    2 / 772 (0.26%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    2
    1
    0
    HYPERKALAEMIA
         subjects affected / exposed
    2 / 772 (0.26%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    HYPERLIPIDAEMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    HYPERTRIGLYCERIDAEMIA
         subjects affected / exposed
    3 / 772 (0.39%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    3
    0
    0
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 772 (0.13%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    1
    1
    0
    IRON DEFICIENCY
         subjects affected / exposed
    0 / 772 (0.00%)
    1 / 162 (0.62%)
    0 / 163 (0.00%)
         occurrences all number
    0
    1
    0
    TYPE 2 DIABETES MELLITUS
         subjects affected / exposed
    0 / 772 (0.00%)
    0 / 162 (0.00%)
    1 / 163 (0.61%)
         occurrences all number
    0
    0
    1
    VITAMIN D DEFICIENCY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0
    ZINC DEFICIENCY
         subjects affected / exposed
    1 / 772 (0.13%)
    0 / 162 (0.00%)
    0 / 163 (0.00%)
         occurrences all number
    1
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Jul 2015
    Treatment duration after randomization was corrected as study medication was only given until Week 30. At Week 32, no study medication was given; Inclusion criteria regarding previous therapy (number 5) were specified to at least one previous conventional systemic therapy; Inclusion criteria regarding chest infection (number 6) were specified, as the methodologies of sonography and ammography were not suitable to identify potential tuberculosis; In exclusion criteria 1 the list of other forms of psoriasis was changed from and to or; In exclusion criteria 13 the specification of uncontrolled hypertension was deleted; It was clarified that, for patients for whom the allocated treatment was missing and could not be replaced in time, a new medication number could be allocated via the unblinded Novartis personnel responsible for study drug packaging, and that in cases where allocation of a new medication number was not possible, unblinding and continuing treatment with open-label medication was allowed; Apremilast was added to the list of prohibited therapies; Discontinuation of study drug for female participants with a positive serum pregnancy test with hCG values > 5 mIU/ml was been added; The assessment schedule table was updated; The counting of affected nails was deleted as the assessment is part of the NAPSI; Time point of evaluation of BSA for eligibility was specified; Severity of PASI was adapted to match the inclusion criteria and the PASI value, which was used as a threshold for entering study phase 2 was corrected to > PASI 75; Assessment of neutrophil bands as part of the hematologic laboratory assessment was deleted; The hCG value which was regarded positive was reduced from > 10 mIU/ml to > 5 mIU/ml; Patients required a DLQI score of > 10 at baseline to be eligible for this study was added; Time when PNQ and PBQ were assessed was specified; Safety monitoring

    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.
    Due to EudraCT system limitations, which EMA is aware of, data using 999 as data points in this record are not an accurate representation of the clinical trial results. Please use https://www.novctrd.com/CtrdWeb/home.novfor complete trial results.
    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.

    European Medicines Agency © 1995-Fri Apr 19 03:20:03 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA