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    Clinical Trial Results:
    REVACEPT, AN INHIBITOR OF PLATELET ADHESION IN SYMPTOMATIC CAROTID STENOSIS: A PHASE II, MULTICENTRE; RANDOMISED, DOSE-FINDING, DOUBLE-BLIND AND PLACEBO-CONTROLLED SUPERIORITY STUDY WITH PARALLEL GROUPS

    Summary
    EudraCT number
    		 2011-001006-10
    Trial protocol
    		 DE   GB  
    Global end of trial date
    23 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Nov 2020
    First version publication date
    15 Nov 2020
    Other versions
    Summary report(s)
    		 CSR Summary 2020-09-10

    Trial information

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    Trial identification
    Sponsor protocol code
    Revacept/CS/02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01645306
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    advanceCOR GmbH
    Sponsor organisation address
    Fraunhoferstraße 9A, Martinsried, Germany, 82152
    Public contact
    Prof. Dr. med. Götz Münch, advanceCOR GmbH, 0049 892000 20410, muench@advancecor.com
    Scientific contact
    Prof. Dr. med. Götz Münch, advanceCOR GmbH, 0049 892000 20410, muench@advancecor.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy objectives are: • Assessment of incidence of microembolic signals (MES) by transcranial Doppler (TCD) examination (before and after treatment) • Rate of MES per hour (before and after treatment) • Cerebral lesion analysis by DWI-NMR • Assessment of neurological status (NIH Stroke Scale) • Clinical endpoints will be summarised cumulatively i.e. before treatment, after treatment, at 3 months and at 12 months. The following endpoints will be recorded: o Rate of all cause death o Rate of stroke-related death o Any TIA, amaurosis fugax or stroke including haemorrhagic stroke • Assessment of cardiovascular outcome including myocardial infarction and re-intervention up to 3 and 12 months
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origins in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. The study and all substantial amendments were reviewed by an Independent Ethics Committee in the United Kingdom: NRES Committee East of England – Cambridge South, The Old Chapel, Royal Standard Court, Nottingham, NG16FS and the lead Ethics Committee Germany: Ethikkommission der Fakultät für Medizin der Technischen Universität München, Ismaninger Straße 22, 81675 München.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Aug 2012
    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
    United Kingdom: 57
    Country: Number of subjects enrolled
    Germany: 101
    Worldwide total number of subjects
    158
    EEA total number of subjects
    158
    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)
    59
    From 65 to 84 years
    94
    85 years and over
    5

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total 160 subjects were enrolled in the study. Of those randomised, 53 subjects received 120 mg Revacept, 54 patients 40 mg Revacept and 51 patients placebo by a single IV infusion. Two subjects received no study medication because they no longer met the eligibility criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 single dose
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Phosphate buffered saline (PBS), 1% sucrose, 4% mannitol
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    single dose

    Arm title
    		 40 mg Revacept
    Arm description
    		 single dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    40 mg Revacept
    Investigational medicinal product code
    Other name
    GPVI-Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    40 mg Revacept, single dose

    Arm title
    		 120 mg Revacept
    Arm description
    		 single dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    120 mg Revacept
    Investigational medicinal product code
    Other name
    GPVI-Fc
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    120 mg Revacept, single dose

    Number of subjects in period 1
    		Placebo 40 mg Revacept 120 mg Revacept
    Started
    51
    54
    53
    Completed
    51
    54
    53

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Randomisation
    Reporting group description
    		 -

    Reporting group values
    		 Randomisation Total
    Number of subjects
    		 158 158
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 59 59
        From 65-84 years
    		 94 94
        85 years and over
    		 5 5
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.1 ± 10.13 -
    Gender categorical
    Units: Subjects
        Female
    		 38 38
        Male
    		 120 120

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 single dose

    Reporting group title
    40 mg Revacept
    Reporting group description
    		 single dose

    Reporting group title
    120 mg Revacept
    Reporting group description
    		 single dose

    Primary: Exploratory

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    End point title
    		 Exploratory [1]
    End point description
    see Synopsis of Clinical Study Report attached
    End point type
    Primary
    End point timeframe
    exploratory
    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: Exploratory trial design - see summary of clinical study report attached for details.
    End point values
    		 Placebo 40 mg Revacept 120 mg Revacept
    Number of subjects analysed
    51
    54
    53
    Units: exploratory
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    IMP administration to 365 days thereafter.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 single dose

    Reporting group title
    40 mg Revacept
    Reporting group description
    		 single dose

    Reporting group title
    120 mg Revacept
    Reporting group description
    		 single dose

    Serious adverse events
    		 Placebo 40 mg Revacept 120 mg Revacept
    Total subjects affected by serious adverse events
         subjects affected / exposed
    17 / 51 (33.33%)
    17 / 54 (31.48%)
    15 / 53 (28.30%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glottis carcinoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Laryngeal cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Malignant melanoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Sarcoma of skin
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Hypertensive crisis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Carotid endarterectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Coronary angioplasty
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Skin lesion removal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Vocal cordectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Asthenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Chest discomfort
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Chest pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Dyspnoea
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Pneumonia aspiration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Pulmonary embolism
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Psychiatric disorders
    Panic attack
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Investigations
    Angiocardiogram
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Biopsy larynx
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac clearance
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Diffusion-weighted brain MRI abnormal
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Injury, poisoning and procedural complications
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Fall
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Rib fracture
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    2 / 51 (3.92%)
    2 / 54 (3.70%)
    2 / 53 (3.77%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Bradycardia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Cerebellar infarction
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clumsiness
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Dizziness
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Epilepsy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Headache
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Hypoaesthesia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Intracranial aneurysm
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Loss of consciousness
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Postictal paralysis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Seizure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Stroke in evolution
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Syncope
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Transient ischaemic attack
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Muscular weakness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (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
    Infections and infestations
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Pneumonia
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (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
    Ketoacidosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         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
    		 Placebo 40 mg Revacept 120 mg Revacept
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 51 (68.63%)
    41 / 54 (75.93%)
    32 / 53 (60.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Glottis carcinoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Laryngeal cancer
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Lung neoplasm malignant
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Malignant melanoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Sarcoma of skin
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Arteriosclerosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Circulatory collapse
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    0
    Haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    1
    0
    2
    Hypertension
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 54 (3.70%)
    2 / 53 (3.77%)
         occurrences all number
    4
    2
    2
    Hypertensive crisis
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    1
    Hypotension
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    1
    1
    2
    Ischaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Lymphoedema
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Phlebitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Surgical and medical procedures
    Carotid endarterectomy
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    1
    Chemotherapy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Coronary angioplasty
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal tube insertion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Skin lesion removal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Ureteral catheterisation
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Vocal cordectomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Catheter site pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Chest discomfort
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Chest pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Condition aggravated
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Facial pain
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Fatigue
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Feeling hot
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Impaired healing
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Oedema
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    1
    Oedema peripheral
         subjects affected / exposed
    2 / 51 (3.92%)
    5 / 54 (9.26%)
    2 / 53 (3.77%)
         occurrences all number
    2
    5
    2
    Pain
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Peripheral swelling
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Sensation of foreign body
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Vascular stent stenosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cough
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    0
    2
    1
    Dysphonia
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    1
    Dyspnoea
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    3
    1
    0
    Emphysema
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngeal oedema
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia aspiration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Pulmonary embolism
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Abnormal dreams
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Alcohol abuse
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Depressed mood
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Depression
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    0
    1
    2
    Hallucination, visual
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Panic attack
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    0
    Panic disorder
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Post stroke depression
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Angiocardiogram
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Biopsy larynx
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Blood creatine increased
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 54 (3.70%)
    0 / 53 (0.00%)
         occurrences all number
    1
    2
    0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Blood creatinine increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Blood glucose increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Blood potassium decreased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urea increased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Blood urine present
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Breath sounds abnormal
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac clearance
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac murmur
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1
    1
    Diffusion-weighted brain MRI abnormal
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    1
    3
    0
    Heart rate decreased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Myocardial necrosis marker increased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Troponin increased
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    1
    Weight decreased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    White blood cell count increased
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Injury, poisoning and procedural complications
    Burns second degree
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Carotid artery restenosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Contusion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    0
    1
    Fall
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    3
    0
    1
    Foot fracture
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Head injury
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural contusion
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Post procedural oedema
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Post procedural swelling
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Postoperative hypertension
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Postoperative hypotension
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    2
    Postoperative wound complication
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural headache
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural hypotension
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Procedural nausea
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Procedural pain
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    3
    1
    2
    Rib fracture
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Skin procedural complication
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Synovial rupture
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Wound complication
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 54 (3.70%)
    0 / 53 (0.00%)
         occurrences all number
    1
    2
    0
    Wound haematoma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Wound secretion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 54 (3.70%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    2
    Angina pectoris
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Atrioventricular block complete
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Bradycardia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    0
    0
    2
    Bundle branch block left
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac arrest
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Cardiac disorder
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac failure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    0
    1
    Cardiogenic shock
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Coronary artery disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Aphasia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Ataxia
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Carotid artery disease
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Carotid artery occlusion
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Carotid artery stenosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Cerebellar infarction
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Cerebral infarction
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 54 (3.70%)
    2 / 53 (3.77%)
         occurrences all number
    2
    2
    2
    Cerebral ischaemia
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    2
    1
    0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    1
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Clonus
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Clumsiness
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    2 / 53 (3.77%)
         occurrences all number
    2
    0
    2
    Dysaesthesia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Dysarthria
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Epilepsy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Facial paralysis
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    1
    Facial paresis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    2
    1
    0
    Hemiplegia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Hypoaesthesia
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    2
    1
    Hypoglossal nerve paresis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Ischaemic stroke
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Loss of consciousness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    1
    Monoparesis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    0
    1
    1
    Muscle spasticity
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    3 / 53 (5.66%)
         occurrences all number
    0
    1
    3
    Paralysis recurrent laryngeal nerve
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Parkinsonism
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Peroneal nerve palsy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Postictal paralysis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Seizure
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    1
    1
    1
    Status epilepticus
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Stroke in evolution
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Subarachnoid haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Syncope
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    1
    2
    1
    Transient ischaemic attack
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    4 / 53 (7.55%)
         occurrences all number
    2
    1
    4
    Visual field defect
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Leukopenia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    blindness
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Retinal artery occlusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Visual impairment
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Constipation
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    2
    1
    0
    Diarrhoea
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphagia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 54 (5.56%)
    1 / 53 (1.89%)
         occurrences all number
    1
    3
    1
    Oesophageal discomfort
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Paraesthesia oral
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 54 (5.56%)
    0 / 53 (0.00%)
         occurrences all number
    0
    3
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Cold sweat
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Drug eruption
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Generalised erythema
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Lividity
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Pemphigoid
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Pigmentation disorder
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Pruritus generalised
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Rash macular
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Scab
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Bladder irritation
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Micturition urgency
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Renal failure
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Urinary retention
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    1
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    2 / 51 (3.92%)
    2 / 54 (3.70%)
    1 / 53 (1.89%)
         occurrences all number
    2
    2
    1
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Joint swelling
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    0
    1
    Muscular weakness
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 54 (1.85%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    0
    Osteonecrosis of jaw
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 54 (5.56%)
    2 / 53 (3.77%)
         occurrences all number
    2
    3
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    2
    0
    0
    Oral candidiasis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Pathogen resistance
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    4
    0
    0
    Postoperative wound infection
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Pyelonephritis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 54 (1.85%)
    2 / 53 (3.77%)
         occurrences all number
    3
    1
    2
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Gout
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Hyperglycaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    1
    0
    0
    Hypokalaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    1
    0
    1
    Hyponatraemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 54 (1.85%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    0
    Ketoacidosis
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 51 (0.00%)
    0 / 54 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    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
    15 Apr 2013
    Protocol Version 7.1 (15.04.2013): Amendment of eligibility criteria to improve recruitment rates.
    12 Sep 2013
    Protocol Version 7.3 (12.09.2013): Safety Reporting timeframes updated upon request of MHRA.
    22 Jul 2014
    Protocol Version 7.4 (22.07.2014): Amendment of eligibility criteria to improve recruitment rates
    27 May 2015
    Prolongation of study due to slower than anticipated recruitment rates. Original proposed study end date: 2015. Revised proposed study end date: 2017.
    22 Jun 2015
    Protocol Version 8 (22.06.2015): Change to exploratory study design upon recommendation of the DSMB due to restrictive eligibility criterion required for primary endpoint.
    14 Sep 2017
    Prolongation of study due to slower than anticipated recruitment rates. Original proposed study end date: 2017. Revised proposed study end date: 2018.

    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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