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    Clinical Trial Results:
    A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED, MULTICENTER, 2-PART PHASE II STUDY ON REPLACEMENT OF STEROIDS BY IFX-1 IN ACTIVE GRANULOMATOSIS WITH POLYANGIITIS (GPA) AND MICROSCOPIC POLYANGIITIS (MPA)

    Summary
    EudraCT number
    		 2018-000768-27
    Trial protocol
    		 CZ   DE   SE   NL   IE   GB   ES   DK   BE   IT  
    Global end of trial date
    08 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jul 2022
    First version publication date
    24 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IFX-1-P2.5
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03895801
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    InflaRx GmbH
    Sponsor organisation address
    Winzerlaer Str. 2, Jena, Germany,
    Public contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508180, info@inflarx.de
    Scientific contact
    InflaRx GmbH, InflaRx GmbH, +49 3641508180, info@inflarx.de
    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
    22 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.
    Protection of trial subjects
    The study was conducted according to the ethical principles of the Declaration of Helsinki and in compliance with International Council for Harmonization (ICH) guideline on Good Clinical Practice (GCP). All persons participating in the conduct of the study (e.g., sponsor, investigators) committed themselves to observe the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013) as well as all pertinent national laws and the ICH guidelines for GCP (June 2017) and CPMP/ICH/135/95 (September 1997). Only subjects that met all inclusion criteria and no exclusion criteria were to enter the study. All patients were free to discontinue their participation in the study at any time.
    Background therapy
    		 Immunosuppressive therapy administered during Remission-Induction Phase: Rituximab or Cyclophosphamide; Immunosuppressive therapy administered during Remission-Maintenance Phase: Rituximab or Cyclophosphamide or Azathioprine or Methotrexate or Mycophenolate Mofetil or Mycophenolate Sodium;
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Apr 2019
    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
    Netherlands: 19
    Country: Number of subjects enrolled
    Sweden: 2
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Czechia: 1
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Italy: 1
    Country: Number of subjects enrolled
    Switzerland: 1
    Country: Number of subjects enrolled
    Russian Federation: 1
    Worldwide total number of subjects
    57
    EEA total number of subjects
    53
    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)
    39
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of 91 subjects screened, 57 were enrolled in the study and randomized to treatment. Reasons for subjects failing screening included failure to meet randomization criteria, physician decision, withdrawal by subject, and other.

    Period 1
    Period 1 title
    Treatment and follow-up period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 IFX-1 + Placebo-GC
    Arm description
    		 IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects randomized to treatment group "IFX-1 + Placebo-GC" or "IFX-1 + Reduced Dose GC" received 800 mg IFX-1 on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16. Subjects randomized to treatment group "Placebo-IFX-1 + Standard Dose GC" received Placebo infusions.

    Arm title
    		 Placebo-IFX-1 + Standard Dose GC
    Arm description
    		 Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Glucocorticoid (GC)
    Investigational medicinal product code
    Other name
    Prednisone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized into treatment group "Placebo-IFX-1 + Standard Dose GC" started with a standard-dose of 60 mg GC daily and were tapered down subsequently. Subjects randomized into treatment group "IFX-1 + Reduced Dose GC", received only half of the starting dose received by subjects in "Placebo-IFX-1 + Standard Dose GC". Subjects randomized into treatment group "IFX-1 + Placebo-GC", only received Placebo GC.

    Arm title
    		 IFX-1 + Reduced Dose GC
    Arm description
    		 IFX-1: intravenously administered; Glucocorticoid (GC): orally administered
    Arm type
    		 Experimental

    Investigational medicinal product name
    IFX-1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects randomized to treatment group "IFX-1 + Placebo-GC" or "IFX-1 + Reduced Dose GC" received 800 mg IFX-1 on Days 1, 4, and 8, and then every other week from Week 2 (Day 15) to Week 16. Subjects randomized to treatment group "Placebo-IFX-1 + Standard Dose GC" received Placebo infusions.

    Investigational medicinal product name
    Glucocorticoid (GC)
    Investigational medicinal product code
    Other name
    Prednisone
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects randomized into treatment group "Placebo-IFX-1 + Standard Dose GC" started with a standard-dose of 60 mg GC daily and were tapered down subsequently. Subjects randomized into treatment group "IFX-1 + Reduced Dose GC", received only half of the starting dose received by subjects in "Placebo-IFX-1 + Standard Dose GC". Subjects randomized into treatment group "IFX-1 + Placebo-GC", only received Placebo GC.

    Number of subjects in period 1
    		IFX-1 + Placebo-GC Placebo-IFX-1 + Standard Dose GC IFX-1 + Reduced Dose GC
    Started
    18
    24
    15
    Completed
    16
    22
    13
    Not completed
    2
    2
    2
         Adverse event, serious fatal
    1
    -
    -
         Physician decision
    -
    -
    1
         Adverse event, non-fatal
    -
    1
    -
         Other reason
    -
    -
    1
         Progressive disease
    1
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    IFX-1 + Placebo-GC
    Reporting group description
    		 IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered

    Reporting group title
    Placebo-IFX-1 + Standard Dose GC
    Reporting group description
    		 Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Reporting group title
    IFX-1 + Reduced Dose GC
    Reporting group description
    		 IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Reporting group values
    		 IFX-1 + Placebo-GC Placebo-IFX-1 + Standard Dose GC IFX-1 + Reduced Dose GC Total
    Number of subjects
    		 18 24 15 57
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 11 19 9 39
        From 65-84 years
    		 7 5 6 18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.8 ( 11.4 ) 55.0 ( 12.3 ) 58.5 ( 14.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 6 5 17
        Male
    		 12 18 10 40
    AAV disease type
    Units: Subjects
        GPA
    		 10 16 11 37
        MPA
    		 8 8 4 20
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all subjects who received at least 1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 1 dose of GCs or Placebo-GCs). Subjects will be analyzed in the treatment group they were randomized to regardless of the treatment they actually received (intention-to-treat principle).

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SAF) consists of all subjects who received at least 1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 1 dose of GCs or Placebo-GCs). Subjects will be analyzed according to the treatment they actually received.

    Subject analysis sets values
    		 Full Analysis Set Safety Set
    Number of subjects
    57
    57
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    39
    39
        From 65-84 years
    18
    18
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    57.8 ( 12.6 )
    57.8 ( 12.6 )
    Gender categorical
    Units: Subjects
        Female
    17
    17
        Male
    40
    40
    AAV disease type
    Units: Subjects
        GPA
    37
    37
        MPA
    20
    20

    End points

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    End points reporting groups
    Reporting group title
    IFX-1 + Placebo-GC
    Reporting group description
    		 IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered

    Reporting group title
    Placebo-IFX-1 + Standard Dose GC
    Reporting group description
    		 Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Reporting group title
    IFX-1 + Reduced Dose GC
    Reporting group description
    		 IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The Full Analysis Set (FAS) consists of all subjects who received at least 1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 1 dose of GCs or Placebo-GCs). Subjects will be analyzed in the treatment group they were randomized to regardless of the treatment they actually received (intention-to-treat principle).

    Subject analysis set title
    Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set (SAF) consists of all subjects who received at least 1 administration of study medication (1 infusion of IFX-1 or Placebo-IFX-1 and at least 1 dose of GCs or Placebo-GCs). Subjects will be analyzed according to the treatment they actually received.

    Primary: Percentage of Subjects Achieving Clinical Response

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    End point title
    		 Percentage of Subjects Achieving Clinical Response
    End point description
    Percentage of subjects achieving clinical response (reduction in Birmingham Vasculitis Activity Score [BVAS] of ≥50% compared to baseline and no worsening in any body system). Subjects who received rescue therapy after Day 1 or discontinued due to related adverse event, lack of efficacy or progressive disease are considered as non-responders at all subsequent visits.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 IFX-1 + Placebo-GC Placebo-IFX-1 + Standard Dose GC IFX-1 + Reduced Dose GC Full Analysis Set
    Number of subjects analysed
    18
    23 [1]
    13 [2]
    54 [3]
    Units: Percentage
        Responder
    89
    96
    77
    89
        Non-responder
    11
    4
    23
    11
    Notes
    [1] - 1 subject with missing assessment
    [2] - 2 subjects with missing assessment
    [3] - 3 subjects with missing assessment
    Statistical analysis title
    		 Group comparison
    Statistical analysis description
    The experimental arm IFX-1 + Placebo-GC and the control arm Placebo-IFX-1 + Standard Dose GC were compared regarding the risk difference for the percentage of subjects with clinical response at Week 16 (FAS) and its 90% confidence interval (CI) based on the Farrington-Manning score.
    Comparison groups
    IFX-1 + Placebo-GC v Placebo-IFX-1 + Standard Dose GC
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Risk difference (RD)
    Point estimate
    -6.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -20.2
         upper limit
    		 6.7

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First administration of IFX-1 or Placebo IFX-1 until end of study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    IFX-1 + Placebo-GC
    Reporting group description
    		 IFX-1: intravenously administered; Placebo-Glucocorticoid (Placebo-GC): orally administered

    Reporting group title
    Placebo-IFX-1 + Standard Dose GC
    Reporting group description
    		 Placebo-IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Reporting group title
    IFX-1 + Reduced Dose GC
    Reporting group description
    		 IFX-1: intravenously administered; Glucocorticoid (GC): orally administered

    Serious adverse events
    		 IFX-1 + Placebo-GC Placebo-IFX-1 + Standard Dose GC IFX-1 + Reduced Dose GC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 18 (27.78%)
    4 / 24 (16.67%)
    3 / 15 (20.00%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    1
    0
    0
    Vascular disorders
    Granulomatosis with polyangiitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Condition aggravated
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (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
    Malaise
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (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
    Pyrexia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (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
    Immune system disorders
    Anti-neutrophil cytoplasmic antibody positive vasculitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (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
    Pulmonary embolism
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (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
    Urinary tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 IFX-1 + Placebo-GC Placebo-IFX-1 + Standard Dose GC IFX-1 + Reduced Dose GC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 18 (83.33%)
    23 / 24 (95.83%)
    15 / 15 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Haemangioma
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 18 (11.11%)
    6 / 24 (25.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    7
    2
    Haematoma
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    0
    0
    2
    Cyanosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Granulomatosis with polyangiitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhage
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Hot flush
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Vasculitis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    White coat hypertension
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 24 (16.67%)
    2 / 15 (13.33%)
         occurrences all number
    0
    4
    2
    Fat tissue increased
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 24 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    1
    5
    0
    Adverse drug reaction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    3 / 15 (20.00%)
         occurrences all number
    0
    1
    3
    Pyrexia
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    2
    Chest pain
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Condition aggravated
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Feeling cold
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Chills
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Feeling hot
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infusion site extravasation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Non-cardiac chest pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Thirst
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Secondary immunodeficiency
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Reproductive system and breast disorders
    Gynaecomastia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    Bronchostenosis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphonia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Epistaxis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal crusting
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Pulmonary embolism
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Stridor
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Wheezing
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 18 (5.56%)
    4 / 24 (16.67%)
    1 / 15 (6.67%)
         occurrences all number
    1
    4
    1
    Insomnia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Mood swings
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Abnormal behaviour
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Agitation
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Anxiety
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Decreased interest
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Depression
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Irritability
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Persistent depressive disorder
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Weight increased
         subjects affected / exposed
    1 / 18 (5.56%)
    5 / 24 (20.83%)
    0 / 15 (0.00%)
         occurrences all number
    1
    5
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Blood sodium increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Cardiac murmur
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Intraocular pressure increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Liver function test increased
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    2 / 15 (13.33%)
         occurrences all number
    0
    1
    2
    Arthropod bite
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Epicondylitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Fall
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Heavy exposure to ultraviolet light
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Skin abrasion
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Spinal compression fracture
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Atrial thrombosis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Cardiac failure
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 18 (16.67%)
    5 / 24 (20.83%)
    2 / 15 (13.33%)
         occurrences all number
    3
    5
    2
    Disturbance in attention
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Dizziness
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Memory impairment
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Paraesthesia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    2 / 15 (13.33%)
         occurrences all number
    2
    0
    2
    Lymphopenia
         subjects affected / exposed
    0 / 18 (0.00%)
    4 / 24 (16.67%)
    0 / 15 (0.00%)
         occurrences all number
    0
    4
    0
    Leukopenia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    3
    0
    0
    Eosinophilia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Neutropenia
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Ear and labyrinth disorders
    Ear congestion
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Ear pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Corneal erosion
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Dacryoadenitis acquired
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Eye pain
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Vision blurred
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Diarrhoea
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    3
    1
    0
    Nausea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    3 / 15 (20.00%)
         occurrences all number
    0
    1
    3
    Vomiting
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    2 / 15 (13.33%)
         occurrences all number
    1
    1
    2
    Abdominal pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gingivitis ulcerative
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Glossodynia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    1 / 15 (6.67%)
         occurrences all number
    1
    2
    1
    Erythema
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    Acne
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Dermatitis acneiform
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Eczema
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema asteatotic
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Hand dermatitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoea
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Urticaria
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    2
    1
    0
    Acute kidney injury
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Haematuria
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Renal impairment
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 24 (25.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    7
    1
    Arthralgia
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 24 (4.17%)
    3 / 15 (20.00%)
         occurrences all number
    4
    1
    4
    Myalgia
         subjects affected / exposed
    2 / 18 (11.11%)
    1 / 24 (4.17%)
    2 / 15 (13.33%)
         occurrences all number
    2
    1
    2
    Back pain
         subjects affected / exposed
    0 / 18 (0.00%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    0
    4
    0
    Limb discomfort
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    Exostosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Facet joint syndrome
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle atrophy
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Osteoporosis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Rhabdomyolysis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Spondylolisthesis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Tendon discomfort
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 18 (5.56%)
    6 / 24 (25.00%)
    5 / 15 (33.33%)
         occurrences all number
    1
    7
    6
    Pneumonia
         subjects affected / exposed
    0 / 18 (0.00%)
    3 / 24 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    0
    3
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 18 (5.56%)
    2 / 24 (8.33%)
    0 / 15 (0.00%)
         occurrences all number
    1
    2
    0
    Cystitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Viral infection
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Asymptomatic COVID-19
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Candida infection
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Folliculitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Helicobacter gastritis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Pustule
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Fluid retention
         subjects affected / exposed
    3 / 18 (16.67%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    4
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 18 (5.56%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    1
    1
    0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    1 / 15 (6.67%)
         occurrences all number
    0
    1
    1
    Hypocalcaemia
         subjects affected / exposed
    2 / 18 (11.11%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    2
    0
    0
    Increased appetite
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    1 / 18 (5.56%)
    0 / 24 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Dyslipidaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Gout
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    Hypercalcaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    0 / 24 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 18 (0.00%)
    1 / 24 (4.17%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Oct 2019
    Protocol Version 4.0, dated 01-Oct-2019, included 31 revisions to the first in all participating countries fully approved Protocol Version 3.0, dated 03-Dec-2018.
    07 Oct 2020
    Protocol Version 5.0, dated 07-Oct-2020, included 10 revisions to formerly fully approved Protocol Version 4.0, dated 01-Oct-2019.

    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
    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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