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    Clinical Trial Results:
    Double-blind, randomised clinical study comparing efficacy and safety of Imiquimod 5% Cream (Test) vs. Aldara® 5% Cream (Reference) vs. Vehicle in patients with actinic keratosis

    Summary
    EudraCT number
    		 2016-000712-15
    Trial protocol
    		 DE  
    Global end of trial date
    18 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Apr 2022
    First version publication date
    06 Apr 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    16-04/Imi-C
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dermapharm AG
    Sponsor organisation address
    Lil-Dagover-Ring 7, Gruenwald, Germany, 82031
    Public contact
    Clinical Research Department, Dermapharm AG, +49 89641860, Clinicaltrials.Dermapharm@dermapharm.com
    Scientific contact
    Clinical Research Department, Dermapharm AG, +49 89641860, Clinicaltrials.Dermapharm@dermapharm.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Dec 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Jan 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment of efficacy and safety of a new cream with imiquimod 5% in comparison with the approved preparation Aldara® 5% Cream and the underlying vehicle in patients with actinic keratosis.
    Protection of trial subjects
    There were no specific measures necessary.
    Background therapy
    		 There was no background therapy.
    Evidence for comparator
    		 The trial aimed to show comparable efficacy and safety to the comparator in order to obtain a generic marketing authorization for the test product.
    Actual start date of recruitment
    03 Apr 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 431
    Worldwide total number of subjects
    431
    EEA total number of subjects
    431
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    47
    From 65 to 84 years
    355
    85 years and over
    29

    Subject disposition

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    Recruitment
    Recruitment details
    		 15 study centers in Germany; first patient first visit: 07 April 2017; last patient last visit: 18 January 2019

    Pre-assignment
    Screening details
    		 Main criteria for inclusion: Women and men ≥ 18 years of age; Diagnosis of actinic keratosis according to generally accepted criteria; Presence of a (connected) area of approximately 25 cm² on either the face or balding scalp that requires medical treatment; Identification of 5 to 10 delimitable target lesions in the treatment area

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    The sachets containing the study medications were masked with a neutral white cover. The attached labels were identical for all three preparations. All three study medications were indistinguishable in terms of appearance. The random code was transferred to the data base not before the following actions were completed: data base closure, finalisation of the SAP, and a Blind Data Review Meeting and Report.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Imiquimod Cream
    Arm description
    		 Test product
    Arm type
    		 Experimental

    Investigational medicinal product name
    Imiquimod 5% Cream
    Investigational medicinal product code
    D06BB10
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Three sachets per week in a treatment cycle of 4 weeks; Application in the evening prior to normal sleeping hours and remaining on the skin for approximately 8 hours

    Arm title
    		 Aldara
    Arm description
    		 Reference Product
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Aldara 5% Cream
    Investigational medicinal product code
    D06BB10
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Three sachets per week in a treatment cycle of 4 weeks; Application in the evening prior to normal sleeping hours and remaining on the skin for approximately 8 hours

    Arm title
    		 Vehicle
    Arm description
    		 Vehicle of test product
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Cutaneous use
    Dosage and administration details
    Three sachets per week in a treatment cycle of 4 weeks; Application in the evening prior to normal sleeping hours and remaining on the skin for approximately 8 hours

    Number of subjects in period 1
    		Imiquimod Cream Aldara Vehicle
    Started
    146
    143
    142
    Completed
    115
    117
    101
    Not completed
    31
    26
    41
         Consent withdrawn by subject
    4
    3
    2
         Adverse event, non-fatal
    12
    7
    2
         Technical-logistic reasons
    2
    7
    7
         Poor tolerability
    2
    1
    -
         Lost to follow-up
    2
    -
    -
         Lack of efficacy
    9
    8
    30

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Treatment Period
    Reporting group description
    		 -

    Reporting group values
    		 Treatment Period Total
    Number of subjects
    		 431 431
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 47 47
        From 65-84 years
    		 355 355
        85 years and over
    		 29 29
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 393 393
    Subject analysis sets

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all randomised patients who had administered the study medication at least once and who provided at least one safety related outcome.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients of the safety data set who complied with the study diagnosis (according to the associated inclusion criteria) and for whom a value of the primary efficacy variable could be derived.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Includes all patients of the ITT data set who do not exhibit any major protocol violation.

    Subject analysis sets values
    		 Safety data set ITT PP
    Number of subjects
    431
    431
    364
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    47
    47
    42
        From 65-84 years
    355
    355
    300
        85 years and over
    29
    29
    22
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    38
    38
    31
        Male
    393
    393
    333

    End points

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    End points reporting groups
    Reporting group title
    Imiquimod Cream
    Reporting group description
    		 Test product

    Reporting group title
    Aldara
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle of test product

    Subject analysis set title
    Safety data set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all randomised patients who had administered the study medication at least once and who provided at least one safety related outcome.

    Subject analysis set title
    ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Includes all patients of the safety data set who complied with the study diagnosis (according to the associated inclusion criteria) and for whom a value of the primary efficacy variable could be derived.

    Subject analysis set title
    PP
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Includes all patients of the ITT data set who do not exhibit any major protocol violation.

    Primary: Treatment effect

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    End point title
    		 Treatment effect
    End point description
    The primary efficacy variable is clinical success (yes, no) at the main examination visit (LOCF). Clinical success is defined as decrease of the target lesions of at least 75% between treatment start (Visit 1) and main examination (4 weeks post (final) treatment).
    End point type
    Primary
    End point timeframe
    Start of treatment (visit 1) to main examination (4 weeks post (final) treatment): either one cycle of 4 weeks treatment or two cycles of 4 weeks treatment with one period of 4 weeks non-treatment in between.
    End point values
    		 Imiquimod Cream Aldara Vehicle ITT PP
    Number of subjects analysed
    118
    116
    142
    431
    364
    Units: Percentage
        number (not applicable)
    77
    75
    40
    221
    188
    Statistical analysis title
    		 Analysis of efficacy
    Statistical analysis description
    The primary objective of this study was to show equivalence of Imiquimod Cream in comparison to Aldara with respect to the primary efficacy variable. Equivalence was statistically proven if the two-sided 95% confidence interval for the mean difference in proportions between Test and Reference was completely contained within [-20; 20].
    Comparison groups
    Imiquimod Cream v Aldara
    Number of subjects included in analysis
    234
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.5
         upper limit
    		 13.7
    Statistical analysis title
    		 Superiority of Test over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the ITT data set.
    Comparison groups
    Imiquimod Cream v Vehicle v ITT
    Number of subjects included in analysis
    691
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Superiority of Reference over Vehicle
    Statistical analysis description
    In order to verify assay sensitivity of the study design, superiority of the two active preparations over vehicle was tested by means of two-sided significance tests with α = 0.05. The primary test of superiority was carried out for the ITT data set.
    Comparison groups
    Aldara v Vehicle v ITT
    Number of subjects included in analysis
    689
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the inclusion visit (visit 0) to the final visit (main visit).
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Imiquimod Cream
    Reporting group description
    		 Test product

    Reporting group title
    Aldara
    Reporting group description
    		 Reference Product

    Reporting group title
    Vehicle
    Reporting group description
    		 Vehicle of test product

    Serious adverse events
    		 Imiquimod Cream Aldara Vehicle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 146 (4.11%)
    5 / 143 (3.50%)
    4 / 142 (2.82%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ulcerative keratitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Duodenitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord leukoplakia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Imiquimod Cream Aldara Vehicle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    109 / 146 (74.66%)
    103 / 143 (72.03%)
    62 / 142 (43.66%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acanthoma
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    0
    2
    0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    3 / 146 (2.05%)
    2 / 143 (1.40%)
    4 / 142 (2.82%)
         occurrences all number
    3
    2
    4
    Malignant neoplasm of eyelid
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Skin papilloma
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    1
    0
    1
    Vascular disorders
    Hot flush
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Lymphoedema
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Varicose ulceration
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Application site dermatitis
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    1
    Application site dysaesthesia
         subjects affected / exposed
    4 / 146 (2.74%)
    4 / 143 (2.80%)
    2 / 142 (1.41%)
         occurrences all number
    4
    4
    2
    Application site eczema
         subjects affected / exposed
    4 / 146 (2.74%)
    7 / 143 (4.90%)
    1 / 142 (0.70%)
         occurrences all number
    4
    7
    1
    Application site erosion
         subjects affected / exposed
    6 / 146 (4.11%)
    4 / 143 (2.80%)
    1 / 142 (0.70%)
         occurrences all number
    6
    4
    1
    Application site erythema
         subjects affected / exposed
    69 / 146 (47.26%)
    58 / 143 (40.56%)
    7 / 142 (4.93%)
         occurrences all number
    69
    58
    7
    Application site exfoliation
         subjects affected / exposed
    12 / 146 (8.22%)
    6 / 143 (4.20%)
    1 / 142 (0.70%)
         occurrences all number
    12
    6
    1
    Application site haematoma
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Application site haemorrhage
         subjects affected / exposed
    2 / 146 (1.37%)
    4 / 143 (2.80%)
    0 / 142 (0.00%)
         occurrences all number
    2
    4
    0
    Application site hypoaesthesia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Application site inflammation
         subjects affected / exposed
    22 / 146 (15.07%)
    17 / 143 (11.89%)
    0 / 142 (0.00%)
         occurrences all number
    22
    17
    0
    Application site irritation
         subjects affected / exposed
    13 / 146 (8.90%)
    13 / 143 (9.09%)
    3 / 142 (2.11%)
         occurrences all number
    13
    13
    3
    Application site oedema
         subjects affected / exposed
    2 / 146 (1.37%)
    6 / 143 (4.20%)
    0 / 142 (0.00%)
         occurrences all number
    2
    6
    0
    Application site pain
         subjects affected / exposed
    20 / 146 (13.70%)
    23 / 143 (16.08%)
    3 / 142 (2.11%)
         occurrences all number
    20
    23
    3
    Application site papules
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    0
    Application site paraesthesia
         subjects affected / exposed
    4 / 146 (2.74%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    4
    2
    0
    Application site pruritus
         subjects affected / exposed
    34 / 146 (23.29%)
    29 / 143 (20.28%)
    4 / 142 (2.82%)
         occurrences all number
    34
    29
    4
    Application site reaction
         subjects affected / exposed
    16 / 146 (10.96%)
    14 / 143 (9.79%)
    0 / 142 (0.00%)
         occurrences all number
    16
    14
    0
    Application site scab
         subjects affected / exposed
    48 / 146 (32.88%)
    50 / 143 (34.97%)
    1 / 142 (0.70%)
         occurrences all number
    48
    50
    1
    Application site swelling
         subjects affected / exposed
    10 / 146 (6.85%)
    11 / 143 (7.69%)
    0 / 142 (0.00%)
         occurrences all number
    10
    11
    0
    Application site ulcer
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Application site vesicles
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Application site warmth
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    2
    1
    0
    Application site wound
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    2
    2
    0
    Asthenia
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    1
    2
    0
    Chills
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    1
    2
    0
    Fatigue
         subjects affected / exposed
    4 / 146 (2.74%)
    4 / 143 (2.80%)
    0 / 142 (0.00%)
         occurrences all number
    4
    4
    0
    Influenza like illness
         subjects affected / exposed
    7 / 146 (4.79%)
    3 / 143 (2.10%)
    4 / 142 (2.82%)
         occurrences all number
    7
    3
    4
    Malaise
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    1
    Peripheral swelling
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Sensation of foreign body
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 143 (0.70%)
    2 / 142 (1.41%)
         occurrences all number
    2
    1
    2
    Dyspnoea
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    0
    0
    2
    Psychiatric disorders
    Apathy
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Middle insomnia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Blood creatine decreased
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    2 / 146 (1.37%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    2
    1
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    General physical health deterioration
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell count decreased
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Eschar
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Fall
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    1
    0
    2
    Overdose
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Retinal injury
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Skin abrasion
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Wound
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Balance disorder
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Dizziness
         subjects affected / exposed
    4 / 146 (2.74%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    4
    1
    1
    Dysgeusia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Head discomfort
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    1
    2
    0
    Headache
         subjects affected / exposed
    6 / 146 (4.11%)
    7 / 143 (4.90%)
    5 / 142 (3.52%)
         occurrences all number
    6
    7
    5
    Hypogeusia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    0
    Sciatica
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    1
    1
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Tinnitus
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Corneal opacity
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Eye oedema
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Eye swelling
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Eyelid oedema
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelids pruritus
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Photopsia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Visual impairment
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 146 (1.37%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    2
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Constipation
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 146 (1.37%)
    2 / 143 (1.40%)
    3 / 142 (2.11%)
         occurrences all number
    2
    2
    3
    Nausea
         subjects affected / exposed
    2 / 146 (1.37%)
    4 / 143 (2.80%)
    1 / 142 (0.70%)
         occurrences all number
    2
    4
    1
    Oral discomfort
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Retching
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth disorder
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Toothache
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    1
    Hepatobiliary disorders
    Perihepatic discomfort
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    1
    0
    1
    Alopecia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Blister
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Dermal cyst
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    3 / 146 (2.05%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    3
    0
    0
    Dermatitis bullous
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Diffuse alopecia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    2 / 146 (1.37%)
    3 / 143 (2.10%)
    3 / 142 (2.11%)
         occurrences all number
    2
    3
    3
    Erythema
         subjects affected / exposed
    3 / 146 (2.05%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    3
    1
    0
    Hyperkeratosis
         subjects affected / exposed
    0 / 146 (0.00%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    0
    2
    0
    Pain of skin
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Papule
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Precancerous skin lesion
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus
         subjects affected / exposed
    5 / 146 (3.42%)
    3 / 143 (2.10%)
    0 / 142 (0.00%)
         occurrences all number
    5
    3
    0
    Rosacea
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Skin erosion
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Skin exfoliation
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Skin irritation
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Skin tightness
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Solar dermatitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Stasis dermatitis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Cystitis noninfective
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    4 / 142 (2.82%)
         occurrences all number
    0
    1
    4
    Back pain
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    1
    0
    3
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    1 / 142 (0.70%)
         occurrences all number
    0
    1
    1
    Joint swelling
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    5 / 142 (3.52%)
         occurrences all number
    0
    0
    5
    Myalgia
         subjects affected / exposed
    1 / 146 (0.68%)
    2 / 143 (1.40%)
    0 / 142 (0.00%)
         occurrences all number
    1
    2
    0
    Pain in extremity
         subjects affected / exposed
    3 / 146 (2.05%)
    2 / 143 (1.40%)
    1 / 142 (0.70%)
         occurrences all number
    3
    2
    1
    Plantar fasciitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    3 / 142 (2.11%)
         occurrences all number
    1
    0
    3
    Infections and infestations
    Application site folliculitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Application site infection
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Application site pustules
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    2 / 142 (1.41%)
         occurrences all number
    0
    1
    2
    Conjunctivitis
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis infected
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Herpes ophthalmic
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Infected bite
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 146 (0.68%)
    3 / 143 (2.10%)
    11 / 142 (7.75%)
         occurrences all number
    1
    3
    11
    Onychomycosis
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Paronychia
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Pulpitis dental
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    1
    0
    1
    Pyoderma
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pustular
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    1
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Urinary tract infection
         subjects affected / exposed
    0 / 146 (0.00%)
    0 / 143 (0.00%)
    1 / 142 (0.70%)
         occurrences all number
    0
    0
    1
    Wound infection
         subjects affected / exposed
    1 / 146 (0.68%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    1
    1
    0
    Injury
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    2 / 142 (1.41%)
         occurrences all number
    1
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperuricaemia
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Iron deficiency
         subjects affected / exposed
    1 / 146 (0.68%)
    0 / 143 (0.00%)
    0 / 142 (0.00%)
         occurrences all number
    1
    0
    0
    Polydipsia
         subjects affected / exposed
    0 / 146 (0.00%)
    1 / 143 (0.70%)
    0 / 142 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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