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    Clinical Trial Results:
    SAFETY AND TOLERABILITY OF ODM-201 IN PATIENTS WITH CASTRATE RESISTANT PROSTATE CANCER: OPEN, NON-RANDOMISED, UNCONTROLLED, MULTICENTRE, EXTENSION STUDY TO STUDY 3104001

    Summary
    EudraCT number
    		 2010-022803-24
    Trial protocol
    		 GB   FI   CZ   EE  
    Global end of trial date
    21 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Nov 2016
    First version publication date
    03 Nov 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    3104002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01429064
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Orion Corporation Orion Pharma
    Sponsor organisation address
    Orionintie 1, Espoo, Finland,
    Public contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, +358 104261,
    Scientific contact
    clinicaltrials@orionpharma.com, Orion Corporation Orion Pharma, +358 104261,
    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
    21 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this extension study is to gain more information about the long-term safety and tolerability of ODM-201.
    Protection of trial subjects
    Tolerability and safety laboratory parameteres were followed once monthly for 6 months, and then every 3 months. Since the France-specific protocol amendment 5 (April 7th 2015), visit interval was every 4 months. Adverse events were recorded for the whole study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2011
    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
    United Kingdom: 32
    Country: Number of subjects enrolled
    Czech Republic: 2
    Country: Number of subjects enrolled
    Estonia: 1
    Country: Number of subjects enrolled
    Finland: 27
    Country: Number of subjects enrolled
    France: 7
    Country: Number of subjects enrolled
    United States: 7
    Worldwide total number of subjects
    76
    EEA total number of subjects
    69
    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)
    23
    From 65 to 84 years
    53
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 17 hospitals in Europe and USA.

    Pre-assignment
    Screening details
    		 Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator were allowed to continue in the ARADES-EXT 3104002 extension study.

    Period 1
    Period 1 title
    ODM-201 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase 1 (Dose Escalation)
    Arm description
    		 ODM-201 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily with food

    Arm title
    		 Phase 2 (200mg/Day)
    Arm description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily with food

    Arm title
    		 Phase 2 (400mg/Day)
    Arm description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily with food

    Arm title
    		 Phase 2 (1400mg/Day)
    Arm description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
    Arm type
    		 Experimental

    Investigational medicinal product name
    ODM-201
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Twice daily with food

    Number of subjects in period 1
    		Phase 1 (Dose Escalation) Phase 2 (200mg/Day) Phase 2 (400mg/Day) Phase 2 (1400mg/Day)
    Started
    19
    22
    19
    16
    Completed
    19
    22
    19
    16

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase 1 (Dose Escalation)
    Reporting group description
    		 ODM-201 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day

    Reporting group title
    Phase 2 (200mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (400mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (1400mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Reporting group values
    		 Phase 1 (Dose Escalation) Phase 2 (200mg/Day) Phase 2 (400mg/Day) Phase 2 (1400mg/Day) Total
    Number of subjects
    		 19 22 19 16 76
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 6 8 6 3 23
        From 65-84 years
    		 13 14 13 13 53
    Gender categorical
    Units: Subjects
        Male
    		 19 22 19 16 76

    End points

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    End points reporting groups
    Reporting group title
    Phase 1 (Dose Escalation)
    Reporting group description
    		 ODM-201 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day

    Reporting group title
    Phase 2 (200mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (400mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (1400mg/Day)
    Reporting group description
    		 Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor

    Primary: Frequency of adverse events

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    End point title
    		 Frequency of adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    From the start of study treatment in the study 3104001 ARADES until the end-of-study visit of ARADES-EXTENSION study 3104002.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive statistics.
    End point values
    		 Phase 1 (Dose Escalation) Phase 2 (200mg/Day) Phase 2 (400mg/Day) Phase 2 (1400mg/Day)
    Number of subjects analysed
    19
    22
    19
    16
    Units: Adverse events
    19
    22
    19
    16
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the start of study treatment administration until the end-of-study visit (4 weeks after the last study treatment dose).
    Adverse event reporting additional description
    Adverse events were reported from the start of study 3104001 ARADES.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Phase 1
    Reporting group description
    		 200 mg day, 400 mg day, 600 mg day, 1000 mg day, 1400 mg day, 1800 mg day

    Reporting group title
    Phase 2 (200mg/Day)
    Reporting group description
    		 Chemotherapy-naive and CYP17 inhibitor-naive, Post-chemotherapy and CYP17 inhibitor-naive, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (400 mg/Day)
    Reporting group description
    		 Chemotherapy-naive and CYP17 inhibitor-naive, Post-chemotherapy and CYP17 inhibitor-naive, Post-CYP17 inhibitor

    Reporting group title
    Phase 2 (1400mg/Day)
    Reporting group description
    		 Chemotherapy-naive and CYP17 inhibitor-naive, Post-chemotherapy and CYP17 inhibitor-naive, Post-CYP17 inhibitor

    Serious adverse events
    		 Phase 1 Phase 2 (200mg/Day) Phase 2 (400 mg/Day) Phase 2 (1400mg/Day)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 19 (26.32%)
    7 / 22 (31.82%)
    3 / 19 (15.79%)
    4 / 16 (25.00%)
         number of deaths (all causes)
    0
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Enterobacter test positive
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral ischaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterobacter infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stenotrophomonas infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Phase 1 Phase 2 (200mg/Day) Phase 2 (400 mg/Day) Phase 2 (1400mg/Day)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    19 / 19 (100.00%)
    22 / 22 (100.00%)
    19 / 19 (100.00%)
    16 / 16 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bowen's disease
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cancer pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Meningioma
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metastases to liver
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vascular disorders
    Aortic arteriosclerosis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Circulatory collapse
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flushing
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Hot flush
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    3 / 19 (15.79%)
    2 / 16 (12.50%)
         occurrences all number
    1
    1
    4
    3
    Hypertension
         subjects affected / exposed
    2 / 19 (10.53%)
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    3 / 16 (18.75%)
         occurrences all number
    2
    2
    3
    3
    Intermittent claudication
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Lymphoedema
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Lymphostasis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Poor peripheral circulation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Superficial vein prominence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 19 (26.32%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    5
    1
    2
    0
    Chest pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Face oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Fatigue
         subjects affected / exposed
    5 / 19 (26.32%)
    3 / 22 (13.64%)
    5 / 19 (26.32%)
    8 / 16 (50.00%)
         occurrences all number
    5
    4
    8
    9
    Influenza like illness
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Localised oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Malaise
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Oedema peripheral
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    5 / 16 (31.25%)
         occurrences all number
    4
    2
    1
    5
    Pain
         subjects affected / exposed
    4 / 19 (21.05%)
    7 / 22 (31.82%)
    1 / 19 (5.26%)
    3 / 16 (18.75%)
         occurrences all number
    4
    7
    1
    3
    Peripheral swelling
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    0
    2
    Pyrexia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    3
    2
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Reproductive system and breast disorders
    Breast tenderness
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gynaecomastia
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    3
    1
    2
    1
    Pelvic pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    2
    0
    1
    Penile oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    3 / 19 (15.79%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    2
    0
    0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    2
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Pharyngeal erythema
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pleural effusion
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Pulmonary embolism
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rales
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Alcohol abuse
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Confusional state
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Depression
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 22 (4.55%)
    3 / 19 (15.79%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    3
    1
    Sleep disorder
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    2
    1
    Blood creatinine increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Blood pressure increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cardiac murmur
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Electrocardiogram PR prolongation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    3
    Heart rate increased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Liver palpable
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urine output increased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    3 / 16 (18.75%)
         occurrences all number
    0
    1
    0
    3
    Fall
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    0
    2
    1
    3
    Foot fracture
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Infusion related reaction
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Laceration
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    2
    Ligament sprain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    1
    Sunburn
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cardiac disorders
    Cardiac failure
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Coronary artery disease
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Palpitations
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    0
    1
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Areflexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dizziness
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 22 (4.55%)
    3 / 19 (15.79%)
    0 / 16 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Headache
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    5
    2
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hyporeflexia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    2
    0
    1
    Monoparesis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Paraesthesia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Paraplegia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Presyncope
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sciatica
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Somnolence
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    0
    1
    Tremor
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    3
    3
    Lymphadenopathy
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Motion sickness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Eye pain
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eye pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Visual acuity reduced
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    1
    1
    Abdominal pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Abnormal faeces
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Anal fissure
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Cheilitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    3 / 19 (15.79%)
    3 / 22 (13.64%)
    3 / 19 (15.79%)
    2 / 16 (12.50%)
         occurrences all number
    3
    3
    3
    2
    Diarrhoea
         subjects affected / exposed
    9 / 19 (47.37%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    1 / 16 (6.25%)
         occurrences all number
    9
    0
    2
    1
    Dry mouth
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    3 / 16 (18.75%)
         occurrences all number
    0
    0
    2
    3
    Flatulence
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    1
    2
    Gastritis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gingival pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    5 / 19 (26.32%)
    2 / 22 (9.09%)
    3 / 19 (15.79%)
    3 / 16 (18.75%)
         occurrences all number
    6
    5
    4
    3
    Oesophagitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Tongue discolouration
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    3 / 19 (15.79%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    4
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dry skin
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Erythema
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Hyperhidrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Nail discolouration
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Onychoclasis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Rash
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    2
    2
    0
    2
    Skin atrophy
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Skin lesion
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Urticaria
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Renal and urinary disorders
    Bladder dilatation
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Dysuria
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 22 (13.64%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    1
    5
    1
    2
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hydronephrosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Lower urinary tract symptoms
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Micturition frequency decreased
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Micturition urgency
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Nocturia
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Pollakiuria
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Urinary incontinence
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    1
    2
    Urinary retention
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Urinary tract inflammation
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    6 / 19 (31.58%)
    7 / 22 (31.82%)
    3 / 19 (15.79%)
    3 / 16 (18.75%)
         occurrences all number
    7
    10
    6
    3
    Arthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Back pain
         subjects affected / exposed
    7 / 19 (36.84%)
    4 / 22 (18.18%)
    5 / 19 (26.32%)
    6 / 16 (37.50%)
         occurrences all number
    7
    5
    7
    7
    Bone pain
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    2
    0
    2
    1
    Bursitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Exposed bone in jaw
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 19 (0.00%)
    3 / 22 (13.64%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    6
    0
    0
    Groin pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Joint lock
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Joint stiffness
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Joint swelling
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    0
    0
    0
    2
    Muscle spasms
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    3
    0
    1
    1
    Muscular weakness
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    1
    2
    0
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    2
    0
    1
    Myalgia
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    3
    0
    Neck pain
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    2 / 16 (12.50%)
         occurrences all number
    1
    0
    0
    2
    Osteoarthritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Pain in extremity
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 22 (9.09%)
    2 / 19 (10.53%)
    0 / 16 (0.00%)
         occurrences all number
    1
    2
    2
    0
    Pain in jaw
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pathological fracture
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    2 / 19 (10.53%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Cellulitis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Eye infection
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Herpes zoster
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    0
    1
    1
    2
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    2
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 22 (9.09%)
    1 / 19 (5.26%)
    1 / 16 (6.25%)
         occurrences all number
    4
    2
    1
    1
    Onychomycosis
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    1
    0
    0
    1
    Pyelonephritis acute
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Tinea cruris
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 22 (9.09%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 19 (15.79%)
    1 / 22 (4.55%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    3
    1
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 22 (4.55%)
    0 / 19 (0.00%)
    0 / 16 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Decreased appetite
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 22 (13.64%)
    5 / 19 (26.32%)
    2 / 16 (12.50%)
         occurrences all number
    1
    3
    6
    2
    Hyperuricaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    1 / 19 (5.26%)
    0 / 16 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypocalcaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 22 (0.00%)
    0 / 19 (0.00%)
    1 / 16 (6.25%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 May 2012
    Number of subjects and dose levels increased.
    16 Jul 2012
    Guidance on ODM-201 interruptions and dose decrease were added.
    07 Apr 2015
    100 MG CAPSULE CHANGED TO 300 MG TABLET FORMULATION. VISIT FREQUENCY CHANGED FROM 3 TO 4 MONTHS INTERVAL.

    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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