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    Clinical Trial Results:
    A three-part randomized, double-blind, placebo-controlled study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic arthritis subtypes of psoriatic and enthesitis-related arthritis.

    Summary
    EudraCT number
    		 2016-003761-26
    Trial protocol
    		 DE   GB   ES   BE   PL   IT  
    Global end of trial date
    09 Nov 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2021
    First version publication date
    23 May 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAIN457F2304
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03031782
    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, novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, novartis.email@novartis.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000380-PIP02-09
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    12 Mar 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Nov 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the time to flare in TP2 is longer with secukinumab for combined ERA and JPsA groups than with placebo
    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
    23 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Italy: 2
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    South Africa: 5
    Country: Number of subjects enrolled
    Spain: 6
    Country: Number of subjects enrolled
    Turkey: 17
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    86
    EEA total number of subjects
    32
    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)
    25
    Adolescents (12-17 years)
    61
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 86 subjects entered TP1

    Pre-assignment
    Screening details
    		 AIN457 treatment group was all subjects who did not take any placebo before or during the period. Placebo in TP2 refers to all subjects who took placebo in TP2 and secukinumab in other periods. For ease of reading,

    Period 1
    Period 1 title
    Treatment Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label: 86 subjects were enrolled in TP1 and 83 subjects (96.5%) of them completed TP1. The reason for discontinuing during TP1 was lack of efficacy (3 subjects). Eight (8) subjects who were JIA ACR 30 non-responders at the end of TP1, hence were discontinued and had their early termination visit. 75 JIA ACR 30 responders in TP1 were randomized to secukinumab (37 subjects) or placebo (38 subjects).

    Arms
    Arm title
    		 AIN457 TP1
    Arm description
    		 secukinumab in all 3 periods
    Arm type
    		 Experimental

    Investigational medicinal product name
    secukinumab
    Investigational medicinal product code
    AIN457
    Other name
    Open-label
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Secukinumab 75 mg or 150 mg subcutaneous injection

    Number of subjects in period 1
    		AIN457 TP1
    Started
    86
    Completed
    83
    Not completed
    3
         Lack of efficacy
    3
    Period 2
    Period 2 title
    Treatment Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Of these 75, 67 (89.3%) completed TP2, and 8 discontinued during TP2 (6 subjects [16.2%] in the secukinumab, and 2 [5.3%] in placebo group). Of the 6 who discontinued, 3 discontinued due to subject/guardian decision, and 1 each discontinued due to AE, lack of efficacy and physician decision. Both subjects in placebo group who discontinued during TP2, discontinued due to AEs. Subjects without disease flare remained in TP2 for duration of study and completed without entering TP3 (35 subjects).

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 AIN457 TP2
    Arm description
    		 secukinumab in all 3 periods
    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
    Secukinumab 75 mg or 150 mg subcutaneous injection

    Arm title
    		 Placebo TP2
    Arm description
    		 Placebo for treatment period 2
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo TP2
    Investigational medicinal product code
    Placebo
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    75 mg or 150 mg subcutaneous injection

    Number of subjects in period 2
    		AIN457 TP2 Placebo TP2
    Started
    37
    38
    Completed
    31
    36
    Not completed
    6
    2
         Physician decision
    1
    -
         Consent withdrawn by subject
    3
    -
         Adverse event, non-fatal
    1
    2
         Lack of efficacy
    1
    -
    Period 3
    Period 3 title
    Treatment Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open-label: 32 subjects entered TP3. Of these, 26 completed TP3 and 6 discontinued prior to week 104. 3 discontinued TP3 due to AEs. The 32 subjects who entered TP3 included 2 who were erroneously switched into TP3 but had no flare at TP2. These 2 were considered as not having flared for efficacy analysis. 1 subject flared on Day 127 at TP2 discontinuation visit; and was discontinued due to SAE and did not enter TP3. Subject was considered as having flared for efficacy analysis for time to flare

    Arms
    Arm title
    		 AIN457 TP3
    Arm description
    		 secukinumab in all 3 periods
    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
    Secukinumab 75 mg or 150 mg subcutaneous injection

    Number of subjects in period 3
    		AIN457 TP3
    Started
    11
    Completed
    10
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AIN457 TP1
    Reporting group description
    		 secukinumab in all 3 periods

    Reporting group values
    		 AIN457 TP1 Total
    Number of subjects
    		 86 86
    Age Categorical
    Units: participants
        <=18 years
    		 86 86
        Between 18 and 65 years
    		 0 0
        >=65 years
    		 0 0
    Age Continuous
    Mean age of participants in years ERA + JPsA = Total
    Units: years
        arithmetic mean (standard deviation)
    		 13.1 ± 3.13 -
    Sex: Female, Male
    ERA + JPsA = Total
    Units:
        JIA Category: ERA|Female
    		 11 11
        JIA Category: JPsA|Female
    		 18 18
        JIA Category: ERA|Male
    		 41 41
        JIA Category: JPsA|Male
    		 16 16
    Race (NIH/OMB)
    ERA + JPsA = Total Unknown or Not Reported Row also means "Other" (none of the above)
    Units: Subjects
        JIA Category: ERA|American Indian/Alaska Native
    		 0 0
        JIA Category: JPsA|American Indian/Alaska Native
    		 0 0
        JIA Category: ERA|Asian
    		 0 0
        JIA Category: JPsA|Asian
    		 1 1
        JIA Category: ERA|Hawaiian/Pacific Islander
    		 0 0
        JIA Category: JPsA|Hawaiian/Pacific Islander
    		 0 0
        JIA Category: ERA|Black or African American
    		 0 0
        JIA Category: JPsA|Black or African American
    		 0 0
        JIA Category: ERA|White
    		 51 51
        JIA Category: JPsA|White
    		 31 31
        JIA Category: ERA|More than one race
    		 0 0
        JIA Category: JPsA|More than one race
    		 0 0
        JIA Category: ERA|Unknown or Not Reported
    		 1 1
        JIA Category: JPsA|Unknown or Not Reported
    		 2 2
    Age Continuous
    Mean age of participants in years ERA + JPsA = Total
    Units: years
        arithmetic mean (standard deviation)
    		 13.1 ± 3.13 -
    Subject analysis sets

    Subject analysis set title
    AIN457 in TP1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    to week 12 TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (<50 kg or >= 50 kg) was administered s.c. At Week 12 (end of TP1), subject's response to study drug was determined (responders entered TP2 and non-responders entered post-treatment follow-up)

    Subject analysis set title
    AIN457 in TP2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    TP2 treatment withdrawal: Secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response at end of Treatment Period 1

    Subject analysis set title
    Placebo in TP2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo s.c. in double-blind Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s with minimum ACR30 at end of TP1

    Subject analysis sets values
    		 AIN457 in TP1 AIN457 in TP2 Placebo in TP2
    Number of subjects
    86
    37
    38
    Age Categorical
    Units: participants
        <=18 years
    86
    37
    38
        Between 18 and 65 years
    0
    0
    0
        >=65 years
    0
    0
    0
    Age Continuous
    Mean age of participants in years ERA + JPsA = Total
    Units: years
        arithmetic mean (standard deviation)
    13.7 ± 2.62
    14.0 ± 2.46
    13.0 ± 2.94
    Sex: Female, Male
    ERA + JPsA = Total
    Units:
        JIA Category: ERA|Female
    11
    4
    4
        JIA Category: JPsA|Female
    18
    9
    7
        JIA Category: ERA|Male
    41
    18
    18
        JIA Category: JPsA|Male
    16
    6
    9
    Race (NIH/OMB)
    ERA + JPsA = Total Unknown or Not Reported Row also means "Other" (none of the above)
    Units: Subjects
        JIA Category: ERA|American Indian/Alaska Native
    0
    0
    0
        JIA Category: JPsA|American Indian/Alaska Native
    0
    0
    0
        JIA Category: ERA|Asian
    0
    0
    0
        JIA Category: JPsA|Asian
    1
    0
    1
        JIA Category: ERA|Hawaiian/Pacific Islander
    0
    0
    0
        JIA Category: JPsA|Hawaiian/Pacific Islander
    0
    0
    0
        JIA Category: ERA|Black or African American
    0
    0
    0
        JIA Category: JPsA|Black or African American
    0
    0
    0
        JIA Category: ERA|White
    51
    22
    21
        JIA Category: JPsA|White
    31
    14
    14
        JIA Category: ERA|More than one race
    0
    0
    0
        JIA Category: JPsA|More than one race
    0
    0
    0
        JIA Category: ERA|Unknown or Not Reported
    1
    0
    1
        JIA Category: JPsA|Unknown or Not Reported
    2
    1
    1
    Age Continuous
    Mean age of participants in years ERA + JPsA = Total
    Units: years
        arithmetic mean (standard deviation)
    12.2 ± 3.66
    13.1 ± 3.14
    10.6 ± 3.70

    End points

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    End points reporting groups
    Reporting group title
    AIN457 TP1
    Reporting group description
    		 secukinumab in all 3 periods
    Reporting group title
    AIN457 TP2
    Reporting group description
    		 secukinumab in all 3 periods

    Reporting group title
    Placebo TP2
    Reporting group description
    		 Placebo for treatment period 2
    Reporting group title
    AIN457 TP3
    Reporting group description
    		 secukinumab in all 3 periods

    Subject analysis set title
    AIN457 in TP1
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    to week 12 TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (<50 kg or >= 50 kg) was administered s.c. At Week 12 (end of TP1), subject's response to study drug was determined (responders entered TP2 and non-responders entered post-treatment follow-up)

    Subject analysis set title
    AIN457 in TP2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    TP2 treatment withdrawal: Secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response at end of Treatment Period 1

    Subject analysis set title
    Placebo in TP2
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo s.c. in double-blind Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s with minimum ACR30 at end of TP1

    Primary: Number of flares per participant in Treatment Period 2 - total

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    End point title
    		 Number of flares per participant in Treatment Period 2 - total
    End point description
    Survival analysis of time to flare in treatment period 2 (TP2) FAS2 ERA + JPsA = total
    End point type
    Primary
    End point timeframe
    From Week 12 until max Week 104
    End point values
    		 AIN457 in TP2 Placebo in TP2
    Number of subjects analysed
    37
    38
    Units: days
        number (not applicable)
    0.27
    0.55
    Statistical analysis title
    		 Flares per participant in TP2
    Statistical analysis description
    Survival analysis of time to flare – TP2 (FAS2)
    Comparison groups
    AIN457 in TP2 v Placebo in TP2
    Number of subjects included in analysis
    75
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.001
    Method
    		 Logrank
    Parameter type
    		 Cox proportional hazard
    Point estimate
    0.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.13
         upper limit
    		 0.63

    Secondary: Percent of participants with Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response at week 12 - by JIA category

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    End point title
    		 Percent of participants with Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response at week 12 - by JIA category
    End point description
    Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category – TP1 (FAS1) The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components - Physician’s Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity. - Parent’s or patient’s Global Assessment of Subject’s overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor. - Functional ability: Childhood Health Assessment Questionnaire (CHAQ©) - Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity) - Number of joints with limitation of motion - Laboratory measure of inflammation: CRP (mg/L)
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 TP1 AIN457 in TP1
    Number of subjects analysed
    86 [1]
    86
    Units: percent of participants
    number (confidence interval 95%)
        ACR 30 ERA
    86.3 (73.1 to 93.8)
    86.3 (73.1 to 93.8)
        ACR 50 ERA
    80.4 (66.5 to 89.7)
    80.4 (66.5 to 89.7)
        ACR 70 ERA
    66.7 (52.0 to 78.9)
    66.7 (52.0 to 78.9)
        ACR 90 ERA
    33.3 (21.1 to 48.0)
    33.3 (21.1 to 48.0)
        ACR 100 ERA
    27.5 (16.3 to 42.0)
    27.5 (16.3 to 42.0)
        ACR 30 JPsA
    96.9 (82.0 to 99.8)
    96.9 (82.0 to 99.8)
        ACR 50 JPsA
    96.9 (82.0 to 99.8)
    96.9 (82.0 to 99.8)
        ACR 70 JPsA
    75.0 (56.2 to 87.9)
    75.0 (56.2 to 87.9)
        ACR 90 JPsA
    50.0 (32.2 to 67.8)
    50.0 (32.2 to 67.8)
        ACR 100 JPsA
    21.9 (9.9 to 40.4)
    21.9 (9.9 to 40.4)
    Notes
    [1] - ERA + JPsA=Total, 52+34=86
    No statistical analyses for this end point

    Secondary: Percent of Participants with Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response at week 12 - total

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    End point title
    		 Percent of Participants with Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response at week 12 - total
    End point description
    Summary of JIA ACR 30/50/70/90/100 for all subjects – TP1 (FAS1) The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components - Physician’s Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity. - Parent’s or patient’s Global Assessment of Subject’s overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor. - Functional ability: Childhood Health Assessment Questionnaire (CHAQ©) - Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity) - Number of joints with limitation of motion - Laboratory measure of inflammation: CRP (mg/L)
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 TP1 AIN457 in TP1
    Number of subjects analysed
    86
    86
    Units: percent of participants
    number (confidence interval 95%)
        ACR 30
    90.4 (81.4 to 95.4)
    90.4 (81.4 to 95.4)
        ACR 50
    86.7 (77.1 to 92.9)
    86.7 (77.1 to 92.9)
        ACR 70
    69.9 (58.7 to 79.2)
    69.9 (58.7 to 79.2)
        ACR 90
    39.8 (29.4 to 51.1)
    39.8 (29.4 to 51.1)
        ACR 100
    25.3 (16.7 to 36.2)
    25.3 (16.7 to 36.2)
    No statistical analyses for this end point

    Secondary: Percent Change from baseline for JIA ACR core components in TP1

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    End point title
    		 Percent Change from baseline for JIA ACR core components in TP1
    End point description
    Summary of JIA ACR core components for all subjects and each JIA category – Treatment period 1 Negative percent change indicates improvement Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    86
    Units: percent change
    arithmetic mean (standard deviation)
        physician global assessment of disease activity
    -77.4 ± 22.67
        parent/subject global assessment of well-being
    -53.1 ± 58.43
        functional ability (CHAQ)
    -53.776 ± 70.5034
        number of joints with active arthritis
    -79.3 ± 34.86
        number of joints with limited range of motion
    -72.5 ± 38.19
    No statistical analyses for this end point

    Secondary: Percent Change in C-reactive protein standardized value (mg/L)

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    End point title
    		 Percent Change in C-reactive protein standardized value (mg/L)
    End point description
    Median Percent Change from baseline for C-reactive protein standardized value (mg/L)
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    82
    Units: percent change
        median (standard deviation)
    -13.587 ± 227.6901
    No statistical analyses for this end point

    Secondary: Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score

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    End point title
    		 Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) score
    End point description
    JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    86
    Units: score
    arithmetic mean (standard deviation)
        JADAS-27
    -10.487 ± 7.2262
        JADAS-71
    -13.403 ± 9.7300
    No statistical analyses for this end point

    Secondary: Change from baseline in total enthesitis count - TP1 (FAS1)

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    End point title
    		 Change from baseline in total enthesitis count - TP1 (FAS1)
    End point description
    Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis. This is the mean (SD) enthesitis count (range 0-16) for FAS subjects A zero score for wither would mean they have no enthesitis, so a zero score is better for the patient
    End point type
    Secondary
    End point timeframe
    Baseline and week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    83
    Units: enthesitis count
        arithmetic mean (standard deviation)
    -1.8 ± 2.31
    No statistical analyses for this end point

    Secondary: Change from baseline in total dactylitis count

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    End point title
    		 Change from baseline in total dactylitis count
    End point description
    Summary of total dactylitis count for all subjects and each JIA category – TP1 (FAS1) Total dactylitis count ranges from 0 to 20. A zero score would mean they have no dactylitis, so a zero score is better for the patient Mean (SD) total dactylitis count of the number of fingers and toes
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    78
    Units: dactylitis count
        arithmetic mean (standard deviation)
    -0.8 ± 1.83
    No statistical analyses for this end point

    Secondary: Number of participants with anti-secukinumab anitbodies

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    End point title
    		 Number of participants with anti-secukinumab anitbodies
    End point description
    Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation. No treatment emergent anti-drug antibodies (ADA) were detected in any sample of subjects of the secukinumab treatment groups. One subject was ADA-positive at Baseline only and negative during treatment.
    End point type
    Secondary
    End point timeframe
    104 weeks
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    86
    Units: participants
    0
    No statistical analyses for this end point

    Secondary: Secukinumab serum concentration

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    End point title
    		 Secukinumab serum concentration
    End point description
    Summary of pharmacokinetic concentrations – Treatment period 1
    End point type
    Secondary
    End point timeframe
    baseline, week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    86
    Units: mcg/mL
    arithmetic mean (standard deviation)
        <50 kg
    30.9 ± 12.9
        >=50 kg
    34.6 ± 11.2
    No statistical analyses for this end point

    Secondary: Number of participants with inactive disease status for all subjects – TP1 (FAS1)

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    End point title
    		 Number of participants with inactive disease status for all subjects – TP1 (FAS1)
    End point description
    Summary of inactive disease status for all subjects – TP1 (FAS1) Clinical inactive disease definition was adapted from the JIA ACR criteria. All were required to be met: - No joints with active arthritis - No uveitis - CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA - Physician’s global assessment of disease activity score ≤ 10mm - Duration of morning stiffness attributable to JIA ≤15 min
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 AIN457 in TP1
    Number of subjects analysed
    83
    Units: partcipants
        number (confidence interval 95%)
    30 (26.1 to 47.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AEs) were collected from first dose of study treatment until end of study treatment plus 12 weeks post treatment, up to maximum duration of 116 weeks.
    Adverse event reporting additional description
    AEs are any untoward sign or symptom that occurred during the study treatment period
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    AIN457
    Reporting group description
    		 AIN457

    Reporting group title
    Placebo in TP2
    Reporting group description
    		 Placebo in TP2

    Reporting group title
    Total
    Reporting group description
    		 Total

    Serious adverse events
    		 AIN457 Placebo in TP2 Total
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 48 (14.58%)
    4 / 38 (10.53%)
    11 / 86 (12.79%)
         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)
    Cholesteatoma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Crohn's disease
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile psoriatic arthritis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Folliculitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 AIN457 Placebo in TP2 Total
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    44 / 48 (91.67%)
    35 / 38 (92.11%)
    79 / 86 (91.86%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papilloma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Skin papilloma
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 38 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    3
    0
    3
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Administration site reaction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Fatigue
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    2
    2
    4
    Feeling hot
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Injection site erythema
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Injection site pain
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    23
    1
    24
    Injection site pruritus
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Injection site reaction
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Medical device pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Peripheral swelling
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    2
    1
    3
    Pyrexia
         subjects affected / exposed
    6 / 48 (12.50%)
    6 / 38 (15.79%)
    12 / 86 (13.95%)
         occurrences all number
    10
    10
    20
    Immune system disorders
    Mite allergy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Social circumstances
    Sexual abuse
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Gynaecomastia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Menstruation irregular
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Scrotal pain
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Testicular pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    3
    0
    3
    Varicocele
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    0
    2
    Cough
         subjects affected / exposed
    8 / 48 (16.67%)
    5 / 38 (13.16%)
    13 / 86 (15.12%)
         occurrences all number
    10
    6
    16
    Dyspnoea
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    2
    4
    6
    Epistaxis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Haemoptysis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Oropharyngeal pain
         subjects affected / exposed
    7 / 48 (14.58%)
    5 / 38 (13.16%)
    12 / 86 (13.95%)
         occurrences all number
    11
    13
    24
    Pharyngeal erythema
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Productive cough
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Respiratory disorder
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    2
    1
    3
    Rhinitis allergic
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    3
    4
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Depressed mood
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Distractibility
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Euphoric mood
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Intentional self-injury
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Mental disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Post-traumatic stress disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 48 (8.33%)
    0 / 38 (0.00%)
    4 / 86 (4.65%)
         occurrences all number
    4
    0
    4
    Aspartate aminotransferase increased
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 38 (2.63%)
    4 / 86 (4.65%)
         occurrences all number
    3
    1
    4
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Blood calcium increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Blood glucose increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Blood phosphorus increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Blood pressure systolic increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Blood triglycerides increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Blood uric acid increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Body temperature increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Eosinophil count increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Liver function test increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Lymphocyte count decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Neutrophil count decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Platelet count increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Transaminases increased
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    1
    2
    3
    Weight increased
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    White blood cell count decreased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    0
    2
    White blood cells urine positive
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    2
    2
    4
    Concussion
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Contusion
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 38 (10.53%)
    6 / 86 (6.98%)
         occurrences all number
    3
    5
    8
    Fall
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    3
    3
    Foot fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Gingival injury
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Hand fracture
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Injection related reaction
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Joint injury
         subjects affected / exposed
    1 / 48 (2.08%)
    4 / 38 (10.53%)
    5 / 86 (5.81%)
         occurrences all number
    1
    5
    6
    Ligament rupture
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Ligament sprain
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 38 (7.89%)
    6 / 86 (6.98%)
         occurrences all number
    5
    3
    8
    Muscle strain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Overdose
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Radius fracture
         subjects affected / exposed
    0 / 48 (0.00%)
    3 / 38 (7.89%)
    3 / 86 (3.49%)
         occurrences all number
    0
    4
    4
    Road traffic accident
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Skin abrasion
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    3
    1
    4
    Skin laceration
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Sunburn
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Tendon injury
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Thermal burn
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Venomous sting
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Congenital, familial and genetic disorders
    Gilbert's syndrome
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Hydrocele
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Cardiac disorders
    Sinus bradycardia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Tachycardia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Epilepsy
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Headache
         subjects affected / exposed
    6 / 48 (12.50%)
    6 / 38 (15.79%)
    12 / 86 (13.95%)
         occurrences all number
    12
    7
    19
    Nerve compression
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Tremor
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Visual field defect
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    2
    3
    Leukopenia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Lymph node pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Lymphopenia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    3
    3
    Neutropenia
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    2
    2
    4
    Splenomegaly
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Ear pain
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    2
    2
    4
    Vertigo
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    3
    4
    7
    Eye disorders
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Eye haematoma
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Myopia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Ocular hyperaemia
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    0
    2
    Uveitis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    3
    0
    3
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Abdominal pain
         subjects affected / exposed
    2 / 48 (4.17%)
    6 / 38 (15.79%)
    8 / 86 (9.30%)
         occurrences all number
    2
    8
    10
    Abdominal pain upper
         subjects affected / exposed
    3 / 48 (6.25%)
    2 / 38 (5.26%)
    5 / 86 (5.81%)
         occurrences all number
    4
    6
    10
    Aphthous ulcer
         subjects affected / exposed
    4 / 48 (8.33%)
    1 / 38 (2.63%)
    5 / 86 (5.81%)
         occurrences all number
    5
    1
    6
    Constipation
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Diarrhoea
         subjects affected / exposed
    11 / 48 (22.92%)
    6 / 38 (15.79%)
    17 / 86 (19.77%)
         occurrences all number
    14
    12
    26
    Dyspepsia
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    2
    2
    4
    Dysphagia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Gastritis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Lip disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Malpositioned teeth
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Mouth ulceration
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    3
    0
    3
    Nausea
         subjects affected / exposed
    11 / 48 (22.92%)
    8 / 38 (21.05%)
    19 / 86 (22.09%)
         occurrences all number
    17
    16
    33
    Noninfective gingivitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Odynophagia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Oral mucosal blistering
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Salivary hypersecretion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Toothache
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Vomiting
         subjects affected / exposed
    5 / 48 (10.42%)
    4 / 38 (10.53%)
    9 / 86 (10.47%)
         occurrences all number
    9
    12
    21
    Hepatobiliary disorders
    Nonalcoholic fatty liver disease
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 48 (2.08%)
    5 / 38 (13.16%)
    6 / 86 (6.98%)
         occurrences all number
    1
    5
    6
    Alopecia
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    1
    2
    3
    Blister
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Dermatitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Dermatitis contact
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    2
    1
    3
    Diffuse alopecia
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Dry skin
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    0
    2
    Dyshidrotic eczema
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Eczema
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    2
    1
    3
    Erythema
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    3
    3
    Exfoliative rash
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Ingrowing nail
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Pruritus
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    3
    2
    5
    Psoriasis
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 38 (10.53%)
    4 / 86 (4.65%)
         occurrences all number
    0
    4
    4
    Rash
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    2
    4
    6
    Skin erosion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Skin plaque
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Skin striae
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    1
    3
    4
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 38 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    5
    0
    5
    Proteinuria
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Renal colic
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 48 (16.67%)
    4 / 38 (10.53%)
    12 / 86 (13.95%)
         occurrences all number
    17
    7
    24
    Arthritis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Back pain
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 38 (7.89%)
    7 / 86 (8.14%)
         occurrences all number
    8
    3
    11
    Enthesopathy
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Groin pain
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Jaw disorder
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Joint effusion
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Joint stiffness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Joint swelling
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    0
    2
    Juvenile psoriatic arthritis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Muscle contracture
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Muscle spasms
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    2
    3
    5
    Myalgia
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Neck pain
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Osteochondrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Pain in extremity
         subjects affected / exposed
    2 / 48 (4.17%)
    4 / 38 (10.53%)
    6 / 86 (6.98%)
         occurrences all number
    5
    5
    10
    Synovial cyst
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Temporomandibular joint syndrome
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Tendonitis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    2
    0
    2
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    0
    2
    Adenoiditis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Bronchitis
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    3
    0
    3
    Conjunctivitis
         subjects affected / exposed
    3 / 48 (6.25%)
    2 / 38 (5.26%)
    5 / 86 (5.81%)
         occurrences all number
    3
    2
    5
    Enterobiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Folliculitis
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Gastroenteritis
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 38 (5.26%)
    4 / 86 (4.65%)
         occurrences all number
    2
    2
    4
    Gastrointestinal infection
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    1
    2
    3
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Helminthic infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Herpes zoster
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Hordeolum
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Impetigo
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 38 (7.89%)
    4 / 86 (4.65%)
         occurrences all number
    1
    5
    6
    Influenza
         subjects affected / exposed
    5 / 48 (10.42%)
    0 / 38 (0.00%)
    5 / 86 (5.81%)
         occurrences all number
    6
    0
    6
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Nail bed infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Nail infection
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    2
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    16 / 48 (33.33%)
    11 / 38 (28.95%)
    27 / 86 (31.40%)
         occurrences all number
    32
    25
    57
    Onychomycosis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 48 (2.08%)
    2 / 38 (5.26%)
    3 / 86 (3.49%)
         occurrences all number
    1
    2
    3
    Oral viral infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    2
    0
    2
    Otitis media
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 38 (7.89%)
    4 / 86 (4.65%)
         occurrences all number
    1
    3
    4
    Paronychia
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 38 (2.63%)
    4 / 86 (4.65%)
         occurrences all number
    6
    1
    7
    Pharyngitis
         subjects affected / exposed
    6 / 48 (12.50%)
    3 / 38 (7.89%)
    9 / 86 (10.47%)
         occurrences all number
    7
    3
    10
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Pilonidal cyst
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Pneumonia
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 38 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    3
    0
    3
    Pulpitis dental
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    4 / 38 (10.53%)
    5 / 86 (5.81%)
         occurrences all number
    1
    4
    5
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 48 (0.00%)
    2 / 38 (5.26%)
    2 / 86 (2.33%)
         occurrences all number
    0
    2
    2
    Rhinitis
         subjects affected / exposed
    3 / 48 (6.25%)
    5 / 38 (13.16%)
    8 / 86 (9.30%)
         occurrences all number
    4
    6
    10
    Sinusitis
         subjects affected / exposed
    3 / 48 (6.25%)
    0 / 38 (0.00%)
    3 / 86 (3.49%)
         occurrences all number
    3
    0
    3
    Skin infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Soft tissue infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Tinea pedis
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Tonsillitis
         subjects affected / exposed
    4 / 48 (8.33%)
    3 / 38 (7.89%)
    7 / 86 (8.14%)
         occurrences all number
    5
    7
    12
    Tracheitis
         subjects affected / exposed
    2 / 48 (4.17%)
    1 / 38 (2.63%)
    3 / 86 (3.49%)
         occurrences all number
    2
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    10 / 48 (20.83%)
    9 / 38 (23.68%)
    19 / 86 (22.09%)
         occurrences all number
    13
    17
    30
    Urinary tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Vaginal infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    2
    2
    Viral infection
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 38 (0.00%)
    2 / 86 (2.33%)
         occurrences all number
    3
    0
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Vulvovaginal mycotic infection
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 48 (2.08%)
    1 / 38 (2.63%)
    2 / 86 (2.33%)
         occurrences all number
    1
    1
    2
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 38 (2.63%)
    1 / 86 (1.16%)
         occurrences all number
    0
    1
    1
    Obesity
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 38 (0.00%)
    1 / 86 (1.16%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Apr 2017
    To clarify and correct errors in the ILAR diagnostic criteria detailed in Appendix 7
    04 Jun 2020
    To adapt protocol to CIVID-19 pandemic related challengest to trial

    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.
    With regard to immunogenicity, no treatment emergent anti-drug antibodies (ADA) were detected in any sample of subjects of the secukinumab treatment groups. One subject (4201005) was ADA-positive at Baseline only and negative during treatment.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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