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    Clinical Trial Results:
    A LONG-TERM STUDY TO ASSESS THE SAFETY AND EFFICACY OF LEBRIKIZUMAB IN PATIENTS WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS (ADJOIN)

    Summary
    EudraCT number
    		 2020-001211-24
    Trial protocol
    		 PL   DE   LV   LT   EE   FR   BG   ES  
    Global end of trial date
    22 Apr 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2025
    First version publication date
    03 Aug 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DRM06-AD07/J2T-DM-KGAA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04392154
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND: 119866, Eli Lilly trial alias: J2T-DM-KGAA, Trial Number: 17789
    Sponsors
    Sponsor organisation name
    Eli Lilly and Company
    Sponsor organisation address
    1 Lilly Corporate Center, Indianapolis, United States, 46285-0001
    Public contact
    Clinical Trial Registry Office, Eli Lilly and Company, 1 317650 421 7200, EU_Lilly_Clinical_Trials@lilly.com
    Scientific contact
    Clinical Trial Registry Office, Eli Lilly and Company, 1 317650 421 7200, EU_Lilly_Clinical_Trials@lilly.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-002536-PIP01-18
    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
    Interim
    Date of interim/final analysis
    19 Jul 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Jul 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Apr 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to assess the long-term safety and efficacy of lebrikizumab in patients with moderate-to-severe AD. This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.
    Protection of trial subjects
    This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2020
    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
    Singapore: 8
    Country: Number of subjects enrolled
    United States: 663
    Country: Number of subjects enrolled
    Ukraine: 9
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Canada: 94
    Country: Number of subjects enrolled
    Latvia: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 27
    Country: Number of subjects enrolled
    Taiwan: 55
    Country: Number of subjects enrolled
    Poland: 158
    Country: Number of subjects enrolled
    Mexico: 4
    Country: Number of subjects enrolled
    Australia: 26
    Country: Number of subjects enrolled
    Bulgaria: 10
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Lithuania: 13
    Country: Number of subjects enrolled
    Germany: 62
    Country: Number of subjects enrolled
    Estonia: 5
    Worldwide total number of subjects
    1153
    EEA total number of subjects
    267
    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)
    292
    Adults (18-64 years)
    799
    From 65 to 84 years
    50
    85 years and over
    12

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study consists of 2 parts: - 100-week primary treatment period where participants were assigned to either Lebrikizumab Q4W or Q2W treatment arms. - 32-week open label extension addendum

    Pre-assignment
    Screening details
    		 Eligible participants from primary treatment period could enter the open-label extension addendum. The current results reported are for the primary completion date (i.e., up to Week 100). Data beyond week 100 (i.e., 32-week open-label extension addendum) will be reported at the time of final results reporting.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Lebrikizumab Q4W
    Arm description
    		 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab Q4W
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.

    Arm title
    		 Lebrikizumab Q2W
    Arm description
    		 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lebrikizumab Q2W
    Investigational medicinal product code
    LY3650150
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.

    Number of subjects in period 1
    		Lebrikizumab Q4W Lebrikizumab Q2W
    Started
    141
    1012
    Completed
    103
    675
    Not completed
    38
    337
         Site Closure
    -
    4
         Consent withdrawn by subject
    18
    138
         Physician decision
    1
    5
         Adverse events
    3
    46
         Geopolitical conflict
    1
    1
         Pregnancy
    1
    8
         Sponsor Decision
    1
    14
         Lost to follow-up
    11
    61
         Due to epidemic/pandemic
    -
    1
         Protocol deviation
    1
    12
         Lack of efficacy
    1
    47

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lebrikizumab Q4W
    Reporting group description
    		 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.

    Reporting group title
    Lebrikizumab Q2W
    Reporting group description
    		 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.

    Reporting group values
    		 Lebrikizumab Q4W Lebrikizumab Q2W Total
    Number of subjects
    		 141 1012 1153
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34.9 ( 16.96 ) 32.5 ( 17.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 82 513 595
        Male
    		 59 499 558
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 16 17
        Asian
    		 21 199 220
        Native Hawaiian or Other Pacific Islander
    		 1 9 10
        Black or African American
    		 9 138 147
        White
    		 106 610 716
        More than one race
    		 3 25 28
        Unknown or Not Reported
    		 0 15 15
    Region of Enrollment
    Units: Subjects
        Singapore
    		 1 7 8
        United States
    		 72 591 663
        Ukraine
    		 5 4 9
        Spain
    		 0 7 7
        Canada
    		 14 80 94
        Latvia
    		 3 5 8
        South Korea
    		 2 25 27
        Taiwan
    		 4 51 55
        Poland
    		 23 135 158
        Mexico
    		 2 2 4
        Australia
    		 3 23 26
        Bulgaria
    		 0 10 10
        France
    		 1 3 4
        Lithuania
    		 1 12 13
        Germany
    		 10 52 62
        Estonia
    		 0 5 5

    End points

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    End points reporting groups
    Reporting group title
    Lebrikizumab Q4W
    Reporting group description
    		 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.

    Reporting group title
    Lebrikizumab Q2W
    Reporting group description
    		 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.

    Primary: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events

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    End point title
    		 Percentage of Participants Discontinued From Study Treatment Due to Adverse Events [1]
    End point description
    Percentage of participants discontinued from study treatment due to adverse events is reported. Analysis Population Description (APD): All participants who received at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    Baseline to Week 100
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As per planned analysis only descriptive data was planned to be analyzed and reported.
    End point values
    		 Lebrikizumab Q4W Lebrikizumab Q2W
    Number of subjects analysed
    141
    1012
    Units: Percentage of participants
        number (not applicable)
    2.1
    4.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100

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    End point title
    		 Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100
    End point description
    The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. APD: All participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    		 Lebrikizumab Q4W Lebrikizumab Q2W
    Number of subjects analysed
    141
    1012
    Units: Percentage of participants
        number (not applicable)
    80.1
    60.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100

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    End point title
    		 Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100
    End point description
    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100%) and the severity of 4 clinical signs (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. APD: All participants who received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 100
    End point values
    		 Lebrikizumab Q4W Lebrikizumab Q2W
    Number of subjects analysed
    141
    1012
    Units: Percentage of participants
        number (not applicable)
    90.4
    79.4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline up to 100 Weeks
    Adverse event reporting additional description
    All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.1
    Reporting groups
    Reporting group title
    Lebrikizumab Q4W
    Reporting group description
    		 250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.

    Reporting group title
    Lebrikizumab Q2W
    Reporting group description
    		 250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.

    Serious adverse events
    		 Lebrikizumab Q4W Lebrikizumab Q2W
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 141 (3.55%)
    41 / 1012 (4.05%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    gastrointestinal stromal tumour
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    endometrial adenocarcinoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [1]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    invasive breast carcinoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    neuroendocrine tumour
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [2]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    prostate cancer
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [3]
    0 / 59 (0.00%)
    2 / 499 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    death
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    influenza like illness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    anaphylactic shock
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    food allergy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pleural effusion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary embolism
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pulmonary mass
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    attention deficit hyperactivity disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression suicidal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    depression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    mixed anxiety and depressive disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    blood potassium decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    accident
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ankle fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    hip fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    multiple injuries
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    splenic rupture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    radius fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    road traffic accident
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subdural haematoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    atrial fibrillation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cardiac failure
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    cervical cord compression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    seizure
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    cataract
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sudden visual loss
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    hiatus hernia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    large intestine polyp
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    small intestinal obstruction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    cholelithiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    dermatitis atopic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    stevens-johnson syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    rotator cuff syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    osteoarthritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    appendicitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    cellulitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    covid-19
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    bacteraemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    pneumonia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    subcutaneous abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    vulval abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [4]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    hypokalaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ketoacidosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Lebrikizumab Q4W Lebrikizumab Q2W
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    89 / 141 (63.12%)
    635 / 1012 (62.75%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    anogenital warts
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    basal cell carcinoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    fibroadenoma of breast
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    lipoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    melanocytic naevus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [5]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    pyogenic granuloma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    seborrhoeic keratosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    skin papilloma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    7 / 1012 (0.69%)
         occurrences all number
    0
    7
    Vascular disorders
    arteriosclerosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    deep vein thrombosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    essential hypertension
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    haematoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hypertension
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    15 / 1012 (1.48%)
         occurrences all number
    0
    15
    orthostatic hypotension
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    raynaud's phenomenon
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    thrombosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    venous thrombosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Pregnancy, puerperium and perinatal conditions
    anembryonic gestation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    morning sickness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [6]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    uterine hypertonus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [7]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    asthenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    chest discomfort
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    3
    chest pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    fatigue
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    8 / 1012 (0.79%)
         occurrences all number
    0
    9
    general physical health deterioration
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    influenza like illness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    injection site bruising
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    injection site haematoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    injection site pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    injection site pruritus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    injection site rash
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    injection site reaction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    12 / 1012 (1.19%)
         occurrences all number
    2
    32
    injection site swelling
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    malaise
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    non-cardiac chest pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    peripheral swelling
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    pyrexia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    swelling face
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vaccination site pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    8 / 1012 (0.79%)
         occurrences all number
    0
    16
    vaccination site reaction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vascular stent stenosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Immune system disorders
    allergy to animal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    allergy to arthropod bite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    allergy to venom
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    anaphylactic reaction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    dust allergy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    drug hypersensitivity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    food allergy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    hypersensitivity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    multiple allergies
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    seasonal allergy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    9 / 1012 (0.89%)
         occurrences all number
    0
    10
    Reproductive system and breast disorders
    abnormal uterine bleeding
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [8]
    0 / 82 (0.00%)
    2 / 513 (0.39%)
         occurrences all number
    0
    2
    breast mass
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    dysmenorrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [9]
    1 / 82 (1.22%)
    2 / 513 (0.39%)
         occurrences all number
    1
    25
    erectile dysfunction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [10]
    1 / 59 (1.69%)
    0 / 499 (0.00%)
         occurrences all number
    1
    0
    fibrocystic breast disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    heavy menstrual bleeding
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [11]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    menopausal symptoms
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [12]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    menstruation irregular
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [13]
    0 / 82 (0.00%)
    3 / 513 (0.58%)
         occurrences all number
    0
    3
    ovarian cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [14]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    prostatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [15]
    0 / 59 (0.00%)
    1 / 499 (0.20%)
         occurrences all number
    0
    1
    testicular cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [16]
    0 / 59 (0.00%)
    1 / 499 (0.20%)
         occurrences all number
    0
    1
    vaginal discharge
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [17]
    1 / 82 (1.22%)
    0 / 513 (0.00%)
         occurrences all number
    1
    0
    vaginal haemorrhage
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [18]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    allergic cough
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    asthma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 1012 (0.49%)
         occurrences all number
    1
    5
    bronchial hyperreactivity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    bronchospasm
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    cough
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    12 / 1012 (1.19%)
         occurrences all number
    1
    13
    dyspnoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    epistaxis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    6
    hypoxia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    nasal congestion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    nasal polyps
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    nasal septum deviation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    oropharyngeal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    6 / 1012 (0.59%)
         occurrences all number
    1
    6
    rhinitis allergic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    5
    rhinorrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    7
    sinus congestion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    sleep apnoea syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    tonsillar hypertrophy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    upper respiratory tract inflammation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Psychiatric disorders
    alcohol abuse
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    alcohol withdrawal syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    anxiety
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    11 / 1012 (1.09%)
         occurrences all number
    1
    11
    apathy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    attention deficit hyperactivity disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    autism spectrum disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    bipolar i disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    depression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    10 / 1012 (0.99%)
         occurrences all number
    0
    10
    insomnia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    7 / 1012 (0.69%)
         occurrences all number
    1
    7
    libido decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    major depression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mania
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mixed anxiety and depressive disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    sleep disorder due to general medical condition, insomnia type
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Investigations
    alanine aminotransferase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    17 / 1012 (1.68%)
         occurrences all number
    0
    18
    aspartate aminotransferase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    7 / 1012 (0.69%)
         occurrences all number
    0
    8
    blood cholesterol increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    4
    blood bicarbonate decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    blood creatinine increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    bilirubin urine
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    bilirubin urine present
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    blood alkaline phosphatase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    blood glucose decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    blood iron decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    blood lactate dehydrogenase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    blood potassium increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    blood pressure diastolic increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    blood pressure increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    blood testosterone decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    0 / 1012 (0.00%)
         occurrences all number
    2
    0
    blood uric acid increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    blood immunoglobulin e increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    cardiac murmur
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    double stranded dna antibody positive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    eosinophil count increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    6 / 1012 (0.59%)
         occurrences all number
    0
    6
    gamma-glutamyltransferase increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    7 / 1012 (0.69%)
         occurrences all number
    2
    7
    glucose urine present
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    haematocrit decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    haemoglobin urine present
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    5
    hepatic enzyme increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    helicobacter test positive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    heart rate increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    intraocular pressure increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mean cell volume increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    liver function test abnormal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    liver function test increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    lymphocyte count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    lymphocyte morphology abnormal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mean cell haemoglobin concentration decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    mean cell haemoglobin decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mean cell volume decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    platelet count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    protein urine present
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    platelet count increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    red blood cell morphology abnormal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    sars-cov-2 test positive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    treponema test positive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tri-iodothyronine free increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    urine ketone body present
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    white blood cells urine positive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    weight decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 1012 (0.20%)
         occurrences all number
    2
    2
    weight increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    5 / 1012 (0.49%)
         occurrences all number
    2
    5
    white blood cell count decreased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    white blood cell count increased
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    abdominal wall wound
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    alcohol poisoning
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    ankle fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    arthropod bite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    4
    animal bite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    4
    chemical burn of skin
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    clavicle fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    concussion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    contusion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    corneal abrasion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    epicondylitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    fall
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    eyelid abrasion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    fibula fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    foot fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    foreign body in ear
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    foreign body in eye
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hip fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    head injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hand fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    limb injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    joint dislocation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    joint injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    ligament rupture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    ligament sprain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    7 / 1012 (0.69%)
         occurrences all number
    1
    7
    lip injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    meniscus injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 1012 (0.49%)
         occurrences all number
    1
    6
    muscle strain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 1012 (0.49%)
         occurrences all number
    1
    5
    nail injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    overdose
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    post procedural haemorrhage
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    procedural dizziness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    2
    procedural pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    post-traumatic neck syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    rib fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    road traffic accident
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    scar
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    radius fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    skin laceration
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    skin abrasion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    superficial injury of eye
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    suture rupture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    soft tissue injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    sports injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    sunburn
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    thermal burn
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    tendon injury
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    traumatic pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tooth fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    vaccination complication
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    10
    wrist fracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    dermoid cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Cardiac disorders
    arrhythmia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    atrial fibrillation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    coronary artery disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    mitral valve incompetence
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    palpitations
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    sinus bradycardia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tachycardia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    ventricular extrasystoles
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Nervous system disorders
    dementia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    dizziness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    disturbance in attention
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    facial paralysis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    headache
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    4 / 141 (2.84%)
    23 / 1012 (2.27%)
         occurrences all number
    4
    31
    hypogeusia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    migraine
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    5
    migraine with aura
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    nerve compression
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    neuropathy peripheral
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    occipital neuralgia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    parkinson's disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    parosmia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    piriformis syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    paraesthesia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    post herpetic neuralgia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    presyncope
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    radiculopathy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    seizure
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    syncope
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    tension headache
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    vith nerve paralysis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    anaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    6 / 1012 (0.59%)
         occurrences all number
    1
    7
    anaemia macrocytic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    eosinophilia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    10 / 1012 (0.99%)
         occurrences all number
    1
    12
    iron deficiency anaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    9 / 1012 (0.89%)
         occurrences all number
    1
    10
    leukopenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    lymphadenopathy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    2 / 1012 (0.20%)
         occurrences all number
    2
    2
    lymphocytosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    lymphopenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    neutropenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    neutrophilia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    normocytic anaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    splenomegaly
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    thrombocytopenia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    thrombocytosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    ear pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    ear pruritus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Eye disorders
    allergic keratitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    astigmatism
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    blepharitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    5
    blepharitis allergic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    cataract
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    chalazion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    conjunctival irritation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    conjunctivitis allergic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    4 / 141 (2.84%)
    29 / 1012 (2.87%)
         occurrences all number
    4
    38
    corneal neovascularisation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    dry eye
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 1012 (0.49%)
         occurrences all number
    1
    5
    eczema eyelids
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    erythema of eyelid
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    eyelid oedema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    eye swelling
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    eye pruritus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    eye irritation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    glaucoma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    keratitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    keratoconus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    myopia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    ocular hyperaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    periorbital dermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    scleritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vitreous floaters
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vitreous detachment
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    visual impairment
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vision blurred
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    4
    vernal keratoconjunctivitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    xerophthalmia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    abdominal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    7 / 1012 (0.69%)
         occurrences all number
    1
    7
    abdominal pain lower
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    abdominal pain upper
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    ascites
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    coeliac disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    colitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    constipation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    dental caries
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    diverticulum intestinal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    diarrhoea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    13 / 1012 (1.28%)
         occurrences all number
    0
    15
    enteritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    duodenal ulcer
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    dyspepsia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    gastrointestinal disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    gastritis erosive
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    gastritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    haematochezia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    5 / 1012 (0.49%)
         occurrences all number
    1
    6
    haemorrhoids
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    3
    intestinal vascular disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    large intestine polyp
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    malpositioned teeth
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    nausea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    9 / 1012 (0.89%)
         occurrences all number
    0
    9
    odynophagia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    rectal polyp
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    stress ulcer
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    toothache
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    tooth impacted
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    vomiting
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    Hepatobiliary disorders
    alcoholic liver disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    cholecystitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    cholelithiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    gallbladder disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    gallbladder polyp
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hyperbilirubinaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hepatomegaly
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hepatic steatosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    6 / 1012 (0.59%)
         occurrences all number
    0
    6
    hypertransaminasaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    jaundice
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    metabolic dysfunction-associated liver disease
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    metabolic dysfunction-associated steatohepatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    acne
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    17 / 1012 (1.68%)
         occurrences all number
    1
    19
    acne varioliformis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    androgenetic alopecia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    alopecia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    7 / 1012 (0.69%)
         occurrences all number
    1
    7
    alopecia areata
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    actinic keratosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    8
    chronic cutaneous lupus erythematosus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    dandruff
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    cutaneous calcification
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    dermatitis acneiform
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    dermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    dermal cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    diffuse alopecia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    dermatitis psoriasiform
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    2
    0
    dermatitis allergic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    3
    dermatitis atopic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    9 / 141 (6.38%)
    67 / 1012 (6.62%)
         occurrences all number
    11
    98
    dermatitis contact
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    5 / 1012 (0.49%)
         occurrences all number
    2
    5
    dry skin
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    eczema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    eczema nummular
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    erythema
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    guttate psoriasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hyperkeratosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hyperhidrosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    ingrowing nail
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    intertrigo
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    keloid scar
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    keratosis pilaris
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    lichen striatus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    lichenoid keratosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    mechanical urticaria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    milia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    nail dystrophy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    nail bed inflammation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    papule
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    parapsoriasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    perioral dermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    petechiae
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    photodermatosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    photosensitivity reaction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    pityriasis rosea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    pruritus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    8 / 1012 (0.79%)
         occurrences all number
    0
    8
    pruritus allergic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    psoriasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    rash
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    rash papular
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    rosacea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    seborrhoeic dermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    6 / 1012 (0.59%)
         occurrences all number
    0
    9
    skin discolouration
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    skin exfoliation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    skin fissures
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    skin irritation
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    skin lesion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    3
    0
    urticaria chronic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    urticaria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    11 / 1012 (1.09%)
         occurrences all number
    0
    11
    urticaria contact
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    Renal and urinary disorders
    bladder obstruction
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    glycosuria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    haematuria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    nephrolithiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    nephropathy toxic
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    proteinuria
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    renal failure
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    renal impairment
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    urinary incontinence
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    androgen deficiency
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    glucocorticoid deficiency
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hypothyroidism
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    polycystic ovarian syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [19]
    0 / 82 (0.00%)
    1 / 513 (0.19%)
         occurrences all number
    0
    1
    thyroid cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    arthralgia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    15 / 1012 (1.48%)
         occurrences all number
    1
    19
    arthritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    arthropathy
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    back pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    14 / 1012 (1.38%)
         occurrences all number
    2
    17
    costochondritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    dupuytren's contracture
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    flank pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    groin pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    hypercreatinaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    intervertebral disc disorder
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    intervertebral disc protrusion
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    joint swelling
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    muscle spasms
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    musculoskeletal chest pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    musculoskeletal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    musculoskeletal stiffness
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    myalgia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    neck pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    osteoarthritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    6
    osteoporosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    pain in extremity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    5
    rhabdomyolysis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    rotator cuff syndrome
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    scoliosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    spinal pain
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    spondylitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tenosynovitis stenosans
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tenosynovitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tendonitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    synovial cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    Infections and infestations
    abscess of eyelid
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    acarodermatitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    acute sinusitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    alveolar osteitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    appendicitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    ascariasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    bacterial vaginosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [20]
    2 / 82 (2.44%)
    1 / 513 (0.19%)
         occurrences all number
    3
    4
    blastocystis infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    campylobacter gastroenteritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    body tinea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    bronchitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    11 / 1012 (1.09%)
         occurrences all number
    0
    11
    bronchitis bacterial
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    covid-19
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    25 / 141 (17.73%)
    156 / 1012 (15.42%)
         occurrences all number
    28
    168
    cellulitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    cellulitis staphylococcal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    chlamydial infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    chronic sinusitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    conjunctivitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 141 (2.13%)
    39 / 1012 (3.85%)
         occurrences all number
    4
    45
    coronavirus infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    4
    conjunctivitis bacterial
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    3 / 1012 (0.30%)
         occurrences all number
    2
    4
    cystitis bacterial
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    cystitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    5
    conjunctivitis viral
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    2
    1
    diverticulitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    ear infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    4 / 1012 (0.40%)
         occurrences all number
    2
    6
    eczema infected
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    erythrasma
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    enterobiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    eye infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    gastrointestinal viral infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    folliculitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    8 / 1012 (0.79%)
         occurrences all number
    3
    9
    furuncle
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    gastrointestinal infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    gastroenteritis viral
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    4
    gastroenteritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    12 / 1012 (1.19%)
         occurrences all number
    1
    15
    gingivitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    genital herpes
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    genital herpes simplex
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    3
    genital infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    giardiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    hordeolum
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    7
    herpes zoster
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    11 / 1012 (1.09%)
         occurrences all number
    1
    15
    herpes virus infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    herpes simplex
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    9 / 1012 (0.89%)
         occurrences all number
    3
    14
    helicobacter infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    helicobacter gastritis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    infected cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    impetigo
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    8 / 1012 (0.79%)
         occurrences all number
    3
    10
    infected dermal cyst
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    2
    infected bite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    infectious mononucleosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    influenza
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    12 / 1012 (1.19%)
         occurrences all number
    1
    12
    infusion site cellulitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    labyrinthitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    laryngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    latent tuberculosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    localised infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    lower respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    malassezia infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    molluscum contagiosum
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    nasal herpes
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    5
    nasopharyngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    13 / 141 (9.22%)
    113 / 1012 (11.17%)
         occurrences all number
    14
    161
    norovirus infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    nail infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    oesophageal candidiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    onychomycosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    oral herpes
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    2 / 141 (1.42%)
    30 / 1012 (2.96%)
         occurrences all number
    3
    46
    orchitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [21]
    0 / 59 (0.00%)
    1 / 499 (0.20%)
         occurrences all number
    0
    1
    otitis externa
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    4
    otitis media
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    4 / 1012 (0.40%)
         occurrences all number
    1
    5
    otitis media acute
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    paronychia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    periodontitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    pharyngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    6
    pharyngitis bacterial
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    pharyngitis streptococcal
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    pulpitis dental
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    pneumonia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    scarlet fever
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    rhinitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    1 / 1012 (0.10%)
         occurrences all number
    1
    1
    sinusitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    4 / 141 (2.84%)
    15 / 1012 (1.48%)
         occurrences all number
    4
    15
    skin bacterial infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    3
    skin candida
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    0 / 1012 (0.00%)
         occurrences all number
    1
    0
    skin infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    subcutaneous abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    staphylococcal skin infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tonsillitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tinea capitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    tinea cruris
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tinea pedis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    tinea versicolour
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    5 / 1012 (0.49%)
         occurrences all number
    0
    5
    tracheitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    toxocariasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    tooth infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    4 / 1012 (0.40%)
         occurrences all number
    0
    4
    tooth abscess
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    urinary tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    3 / 141 (2.13%)
    28 / 1012 (2.77%)
         occurrences all number
    3
    33
    upper respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    7 / 141 (4.96%)
    48 / 1012 (4.74%)
         occurrences all number
    11
    62
    vaginal infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [22]
    0 / 82 (0.00%)
    2 / 513 (0.39%)
         occurrences all number
    0
    2
    viral upper respiratory tract infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    viral pharyngitis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    viral infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    wound infection
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    vulvovaginal candidiasis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed [23]
    1 / 82 (1.22%)
    2 / 513 (0.39%)
         occurrences all number
    1
    2
    Metabolism and nutrition disorders
    dehydration
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    decreased appetite
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    2 / 1012 (0.20%)
         occurrences all number
    1
    2
    diabetes mellitus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    dyslipidaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    food intolerance
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    glucose tolerance impaired
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    gout
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    7 / 1012 (0.69%)
         occurrences all number
    0
    8
    haemochromatosis
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hypercholesterolaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    1 / 141 (0.71%)
    3 / 1012 (0.30%)
         occurrences all number
    1
    3
    hypophosphataemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hypokalaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    hypoglycaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hyperuricaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    hypernatraemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    hyperlipidaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    3 / 1012 (0.30%)
         occurrences all number
    0
    3
    hyperglycaemia
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    lactose intolerance
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    obesity
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    4
    periarthritis calcarea
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    1 / 1012 (0.10%)
         occurrences all number
    0
    1
    type 2 diabetes mellitus
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    vitamin d deficiency
    alternative dictionary used: MedDRA 27.1
         subjects affected / exposed
    0 / 141 (0.00%)
    2 / 1012 (0.20%)
         occurrences all number
    0
    2
    Notes
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Dec 2020
    Protocol Amendment (1): Added 48 weeks of treatment (for total of 100 weeks) to gain additional safety data on long-term exposures. Removed male contraception requirements as supported by toxicology data. Added hepatic safety monitoring section with detailed guidance. Added instructions for withholding study drug when warranted for participant safety.
    14 Dec 2022
    Protocol Amendment (2): Clarified when Study KGAK participants receive blinded and open-label study drug. Clarified unblinded interim analysis regarding Study KGAK. Included language that live vaccines are not permitted during the trial. Deleted timing requirement to report AESIs. Included that additional data will be collected in eCRF for AESIs. Included that “the investigator or designee” may discuss discontinuation of study drug or dose changes due to an AE. Included the Infections and Opportunistic Infections section. Included details related to mITT population. Included product complaints language.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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
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