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    Clinical Trial Results:
    Global multicenter, open-label, randomized, event-driven, active-controlled study comparing a rivaroxaban-based antithrombotic strategy to an antiplatelet-based strategy after transcatheter aortic valve replacement (TAVR) to optimize clinical outcomes

    Summary
    EudraCT number
    		 2015-001975-30
    Trial protocol
    		 DE   ES   BE   NO   AT   DK   SE   NL   GB   FR   CZ   IT  
    Global end of trial date
    27 Nov 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Dec 2019
    First version publication date
    18 Dec 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BAY59-7939/17938
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02556203
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bayer AG
    Sponsor organisation address
    Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
    Public contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.com
    Scientific contact
    Therapeutic Area Head, Bayer AG, clinical-trials-contact@bayer.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
    31 Jan 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    •Assess whether a rivaroxaban-based anticoagulation strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing death or first thromboembolic events (DTE). This comparison was hierarchically preceded by a non-inferiority test that had to be satisfied (i.e., the null hypothesis had to be rejected). •Assess the primary bleeding events (PBE) of the rivaroxaban-based strategy, following TAVR, compared to an antiplatelet-based strategy. PBE was defined as the composite of life-threatening, disabling, or major bleeding events and was classified according to the Valve Academic Research Consortium (VARC) definitions.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Dec 2015
    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
    Canada: 61
    Country: Number of subjects enrolled
    United States: 318
    Country: Number of subjects enrolled
    Czech Republic: 17
    Country: Number of subjects enrolled
    Poland: 19
    Country: Number of subjects enrolled
    Austria: 78
    Country: Number of subjects enrolled
    Belgium: 32
    Country: Number of subjects enrolled
    Denmark: 149
    Country: Number of subjects enrolled
    France: 128
    Country: Number of subjects enrolled
    Germany: 520
    Country: Number of subjects enrolled
    Italy: 58
    Country: Number of subjects enrolled
    Netherlands: 27
    Country: Number of subjects enrolled
    Norway: 38
    Country: Number of subjects enrolled
    Spain: 51
    Country: Number of subjects enrolled
    Sweden: 7
    Country: Number of subjects enrolled
    Switzerland: 69
    Country: Number of subjects enrolled
    United Kingdom: 72
    Worldwide total number of subjects
    1644
    EEA total number of subjects
    1196
    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)
    34
    From 65 to 84 years
    1138
    85 years and over
    472

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at 136 centers world-wide between 16 Dec 2015 (first patient’s first visit) and 27 Nov 2018 (last patient’s last visit).

    Pre-assignment
    Screening details
    		 A total of 1674 subjects were screened, of which 1644 were randomly assigned to either of the two treatment arms and 1608 subjects started treatment with study medication.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rivaroxaban (Xarelto, BAY59-7939)
    Arm description
    		 Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban (Xarelto, BAY59-7939)
    Investigational medicinal product code
    BAY59-7939
    Other name
    Xarelto
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    10 mg OD (once-daily)

    Investigational medicinal product name
    Acetylsalicylic Acid (ASA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75-100mg OD (once-daily)

    Investigational medicinal product name
    Rivaroxaban (Xarelto, BAY59-7939)
    Investigational medicinal product code
    BAY59-7939
    Other name
    Xarelto
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In case of NOAF, 20/15 mg OD (once-daily)

    Arm title
    		 Antiplatelet
    Arm description
    		 Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75mg OD (once-daily)

    Investigational medicinal product name
    Acetylsalicylic Acid (ASA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75-100mg OD (once-daily)

    Investigational medicinal product name
    Vitamin K antagonist (VKA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines

    Number of subjects in period 1
    		Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Started
    826
    818
    Received treatment
    801
    807
    Completed
    799
    792
    Not completed
    27
    26
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    21
    21
         Lost to follow-up
    5
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939)
    Reporting group description
    		 Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.

    Reporting group title
    Antiplatelet
    Reporting group description
    		 Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

    Reporting group values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet Total
    Number of subjects
    		 826 818 1644
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 80.38 ± 7.12 80.77 ± 5.99 -
    Gender Categorical
    Units: Subjects
        Female
    		 400 413 813
        Male
    		 426 405 831
    Race
    Units: Subjects
        Asia
    		 2 1 3
        Black or African American
    		 9 7 16
        Native Hawaiian or other Pacific Islander
    		 0 2 2
        Not reported
    		 123 115 238
        White
    		 692 693 1385
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 26 17 43
        Not Hispanic or Latino
    		 677 694 1371
        Not reported
    		 123 107 230

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939)
    Reporting group description
    		 Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15mg once-daily) was to be continued alone.

    Reporting group title
    Antiplatelet
    Reporting group description
    		 Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA to target INR 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

    Subject analysis set title
    Full analysis set (FAS)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Included all randomized subjects and results presented according to randomized treatment arm (1644 subjects overall)

    Subject analysis set title
    Safety analysis set (SAF)
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Included all randomized subjects and results presented according to actual treatment arm that matches the randomized arm (1608 subjects).

    Primary: Number of subjects with death or adjudicated thromboembolic event (DTE)

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    End point title
    		 Number of subjects with death or adjudicated thromboembolic event (DTE)
    End point description
    Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    End point type
    Primary
    End point timeframe
    From randomization until end of study medication + 2 days
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    801
    807
    Units: Subjects
    68
    63
    Statistical analysis title
    		 DTE (non-inferiority)
    Statistical analysis description
    Non-inferiority was tested in Safety analysis set (SAF)
    Comparison groups
    Antiplatelet v Rivaroxaban (Xarelto, BAY59-7939)
    Number of subjects included in analysis
    1608
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 > 0.05
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Confidence interval
         level
    		 97.5%
         sides
    1-sided
         lower limit
    		 -
         upper limit
    		 1.7040824

    Primary: Number of subjects with death or adjudicated thromboembolic event (DTE)

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    End point title
    		 Number of subjects with death or adjudicated thromboembolic event (DTE)
    End point description
    Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    End point type
    Primary
    End point timeframe
    From randomization until efficacy cut-off date (13-Aug-2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    105
    78
    Statistical analysis title
    		 DTE (superiority)
    Statistical analysis description
    Superiority test was analyzed on Full Analysis Set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.04223
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.81

    Primary: Number of participants with primary bleeding event (PBE)

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    End point title
    		 Number of participants with primary bleeding event (PBE)
    End point description
    PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding.
    End point type
    Primary
    End point timeframe
    From randomization until efficacy cut-off date (13-Aug-2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    46
    31
    Statistical analysis title
    		 Primary bleeding event
    Statistical analysis description
    PBE was described in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.07745
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 2.37
    Notes
    [1] - Descriptive

    Secondary: Number of participants with Net-clinical benefit

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    End point title
    		 Number of participants with Net-clinical benefit
    End point description
    The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety).
    End point type
    Secondary
    End point timeframe
    From randomization until efficacy cut-off date (13-Aug-2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    137
    100
    Statistical analysis title
    		 Net-clinical benefit
    Statistical analysis description
    Net-clinical benefit was tested in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.01156
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 1.8

    Secondary: Number of participants with cardiovascular death or thromboembolic event

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    End point title
    		 Number of participants with cardiovascular death or thromboembolic event
    End point description
    Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication).
    End point type
    Secondary
    End point timeframe
    From randomization until efficacy cut-off date (13-Aug-2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    83
    68
    Statistical analysis title
    		 Cardiovascular death or thromboembolic event
    Statistical analysis description
    Secondary efficacy endpoint was tested in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.21595
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.22
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.69

    Secondary: Number of participants with TIMI (Thrombolysis In Myocardial Infarction) major / minor bleeds

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    End point title
    		 Number of participants with TIMI (Thrombolysis In Myocardial Infarction) major / minor bleeds
    End point description
    Composite of TIMI major and minor bleedings
    End point type
    Secondary
    End point timeframe
    From randomization until efficacy cut-off date (13 August 2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    42
    24
    Statistical analysis title
    		 TIMI major / minor bleeds
    Statistical analysis description
    TIMI major and minor bleeds were described in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.02216
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.08
         upper limit
    		 2.94
    Notes
    [2] - Descriptive

    Secondary: Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeds

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    End point title
    		 Number of participants with ISTH (International Society on Thrombosis and Haemostasis) major bleeds
    End point description
    ISTH major bleeds
    End point type
    Secondary
    End point timeframe
    From randomization until efficacy cut-off date (13 August 2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    49
    30
    Statistical analysis title
    		 ISTH major bleeds
    Statistical analysis description
    ISTH major bleeds were described in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.02702
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.05
         upper limit
    		 2.62
    Notes
    [3] - Descriptive

    Secondary: Number of participants with composite bleeding endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 bleeds

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    End point title
    		 Number of participants with composite bleeding endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 bleeds
    End point description
    Composite of BARC 2,3 or 5 bleedings
    End point type
    Secondary
    End point timeframe
    From randomization until efficacy cut-off date (13 August 2018)
    End point values
    		 Rivaroxaban (Xarelto, BAY59-7939) Antiplatelet
    Number of subjects analysed
    826
    818
    Units: Subjects
    148
    85
    Statistical analysis title
    		 BARC 2, 3 or 5 bleedings
    Statistical analysis description
    BARC 2, 3 or 5 bleedings were described in Full analysis set (FAS)
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) v Antiplatelet
    Number of subjects included in analysis
    1644
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.00001
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 2.41
    Notes
    [4] - Descriptive

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After study medication start until end of study medication plus 2 days. Timeframe for number of death (all causes): After study medication start until last contact date.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Antiplatelet arm
    Reporting group description
    		 Subjects were treated with clopidogrel (75mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, clopidogrel was discontinued and ASA (75-100mg once-daily) was to be continued alone. In the event of NOAF, subjects should start treatment of open-label VKA (Vitamin K antagonist) to target INR (international normalized ratio) 2 to 3 (according to guidelines) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and VKA was to be continued alone.

    Reporting group title
    Rivaroxaban arm
    Reporting group description
    		 Subjects were treated with Rivaroxaban (10mg once-daily) and ASA (75-100mg once-daily) within first 90 days after randomization. After 90 days, ASA was discontinued and rivaroxaban (10mg once-daily) was to be continued alone. In the event of NOAF (New Onset of Atrial Fibrillation), subjects should be switched to rivaroxaban (20/15 mg once-daily) and ASA (75-100mg once-daily) within first 90 days. After 90 days, ASA was discontinued and rivaroxaban (20/15 mg once-daily) was to be continued alone.

    Serious adverse events
    		 Antiplatelet arm Rivaroxaban arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    282 / 807 (34.94%)
    296 / 801 (36.95%)
         number of deaths (all causes)
    43
    70
         number of deaths resulting from adverse events
    26
    39
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    3 / 807 (0.37%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liposarcoma
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myeloid leukaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm malignant
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear neoplasm malignant
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal neoplasm
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic dissection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    5 / 807 (0.62%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    5 / 807 (0.62%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    8 / 807 (0.99%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Carotid endarterectomy
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cochlea implant
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia repair
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia repair
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cyst excision
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder arthroplasty
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip surgery
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental operation
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid operation
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear operation
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker adjustment
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transcatheter arterial chemoembolisation
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    5 / 807 (0.62%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Fatigue
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden death
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker generated arrhythmia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Sarcoidosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    7 / 807 (0.87%)
    7 / 801 (0.87%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    6 / 807 (0.74%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pneumothorax
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 807 (0.12%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wheezing
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Undersensing
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device battery issue
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory marker increased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transvalvular pressure gradient increased
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    5 / 807 (0.62%)
    12 / 801 (1.50%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic injury
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary bypass stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypoparathyroidism
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product administration error
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Neuroacanthocytosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    25 / 807 (3.10%)
    17 / 801 (2.12%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial tachycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    15 / 807 (1.86%)
    12 / 801 (1.50%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    6 / 807 (0.74%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 807 (0.12%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure
         subjects affected / exposed
    16 / 807 (1.98%)
    16 / 801 (2.00%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 19
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    5 / 807 (0.62%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    3 / 807 (0.37%)
    8 / 801 (1.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular disorder
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Conduction disorder
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    3 / 807 (0.37%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary ostial stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    4 / 807 (0.50%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Axonal neuropathy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    4 / 807 (0.50%)
    9 / 801 (1.12%)
         occurrences causally related to treatment / all
    0 / 4
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic encephalopathy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental impairment
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    23 / 807 (2.85%)
    19 / 801 (2.37%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ballismus
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 807 (0.00%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular detachment
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal ulcer
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal obstruction
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac artery stenosis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lichen sclerosus
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigus
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    17 / 807 (2.11%)
    10 / 801 (1.25%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocrine disorders
    Primary adrenal insufficiency
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    4 / 807 (0.50%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    10 / 807 (1.24%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteopenia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    4 / 807 (0.50%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    7 / 807 (0.87%)
    8 / 801 (1.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Endocarditis bacterial
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    4 / 807 (0.50%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    22 / 807 (2.73%)
    23 / 801 (2.87%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 28
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pneumonia influenzal
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 807 (0.37%)
    7 / 801 (0.87%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Sialoadenitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 807 (0.37%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 807 (0.12%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound abscess
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis bacterial
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve abscess
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-hypodermitis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic encephalopathy
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal endocarditis
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site joint infection
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 807 (0.12%)
    4 / 801 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 807 (0.00%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 807 (0.12%)
    1 / 801 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 807 (0.25%)
    5 / 801 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 807 (0.12%)
    0 / 801 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.2%
    Non-serious adverse events
    		 Antiplatelet arm Rivaroxaban arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    302 / 807 (37.42%)
    359 / 801 (44.82%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Basal cell carcinoma
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Vascular disorders
    Blood pressure fluctuation
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Haematoma
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Hypertensive crisis
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    2
    4
    Hypertension
         subjects affected / exposed
    28 / 807 (3.47%)
    26 / 801 (3.25%)
         occurrences all number
    28
    26
    Hypotension
         subjects affected / exposed
    10 / 807 (1.24%)
    3 / 801 (0.37%)
         occurrences all number
    11
    3
    Intermittent claudication
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Lymphoedema
         subjects affected / exposed
    0 / 807 (0.00%)
    4 / 801 (0.50%)
         occurrences all number
    0
    4
    Orthostatic hypotension
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 807 (0.25%)
    6 / 801 (0.75%)
         occurrences all number
    2
    6
    Peripheral venous disease
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Surgical and medical procedures
    Cataract operation
         subjects affected / exposed
    1 / 807 (0.12%)
    6 / 801 (0.75%)
         occurrences all number
    1
    9
    Tooth extraction
         subjects affected / exposed
    0 / 807 (0.00%)
    10 / 801 (1.25%)
         occurrences all number
    0
    10
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    2
    4
    Chest pain
         subjects affected / exposed
    12 / 807 (1.49%)
    10 / 801 (1.25%)
         occurrences all number
    12
    10
    Fatigue
         subjects affected / exposed
    7 / 807 (0.87%)
    13 / 801 (1.62%)
         occurrences all number
    7
    15
    Gait disturbance
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Oedema
         subjects affected / exposed
    3 / 807 (0.37%)
    2 / 801 (0.25%)
         occurrences all number
    3
    2
    Oedema peripheral
         subjects affected / exposed
    20 / 807 (2.48%)
    16 / 801 (2.00%)
         occurrences all number
    21
    16
    Pyrexia
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    4
    1
    Peripheral swelling
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences all number
    3
    0
    General physical health deterioration
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences all number
    3
    0
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 807 (0.62%)
    4 / 801 (0.50%)
         occurrences all number
    5
    4
    Drug intolerance
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    6 / 807 (0.74%)
    8 / 801 (1.00%)
         occurrences all number
    7
    9
    Cough
         subjects affected / exposed
    6 / 807 (0.74%)
    2 / 801 (0.25%)
         occurrences all number
    6
    2
    Dyspnoea
         subjects affected / exposed
    6 / 807 (0.74%)
    17 / 801 (2.12%)
         occurrences all number
    6
    17
    Pleural effusion
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    4
    4
    Dyspnoea exertional
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Respiratory failure
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Confusional state
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Insomnia
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Mental status changes
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Product issues
    Device dislocation
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 807 (0.50%)
    2 / 801 (0.25%)
         occurrences all number
    4
    2
    Blood glucose increased
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3
    C-reactive protein increased
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences all number
    3
    1
    Blood pressure increased
         subjects affected / exposed
    4 / 807 (0.50%)
    4 / 801 (0.50%)
         occurrences all number
    4
    4
    Electrocardiogram QRS complex prolonged
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    International normalised ratio abnormal
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences all number
    3
    0
    Haemoglobin decreased
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences all number
    3
    1
    Intraocular pressure increased
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Weight increased
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Ejection fraction decreased
         subjects affected / exposed
    5 / 807 (0.62%)
    2 / 801 (0.25%)
         occurrences all number
    5
    2
    Transvalvular pressure gradient increased
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    16 / 807 (1.98%)
    18 / 801 (2.25%)
         occurrences all number
    16
    18
    Ligament sprain
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Rib fracture
         subjects affected / exposed
    4 / 807 (0.50%)
    0 / 801 (0.00%)
         occurrences all number
    4
    0
    Anaemia postoperative
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Contusion
         subjects affected / exposed
    8 / 807 (0.99%)
    11 / 801 (1.37%)
         occurrences all number
    11
    11
    Skin laceration
         subjects affected / exposed
    0 / 807 (0.00%)
    5 / 801 (0.62%)
         occurrences all number
    0
    5
    Skin abrasion
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    4 / 807 (0.50%)
    2 / 801 (0.25%)
         occurrences all number
    5
    2
    Atrial fibrillation
         subjects affected / exposed
    44 / 807 (5.45%)
    43 / 801 (5.37%)
         occurrences all number
    45
    44
    Atrial flutter
         subjects affected / exposed
    5 / 807 (0.62%)
    2 / 801 (0.25%)
         occurrences all number
    5
    2
    Atrial tachycardia
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3
    Atrioventricular block first degree
         subjects affected / exposed
    8 / 807 (0.99%)
    7 / 801 (0.87%)
         occurrences all number
    8
    7
    Bradycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Bundle branch block left
         subjects affected / exposed
    7 / 807 (0.87%)
    6 / 801 (0.75%)
         occurrences all number
    7
    6
    Cardiac failure
         subjects affected / exposed
    11 / 807 (1.36%)
    14 / 801 (1.75%)
         occurrences all number
    11
    15
    Cardiac failure chronic
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Cardiac failure congestive
         subjects affected / exposed
    3 / 807 (0.37%)
    5 / 801 (0.62%)
         occurrences all number
    3
    5
    Left ventricular failure
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Mitral valve incompetence
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Palpitations
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences all number
    3
    1
    Sinus bradycardia
         subjects affected / exposed
    3 / 807 (0.37%)
    2 / 801 (0.25%)
         occurrences all number
    3
    2
    Sinus tachycardia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Tachycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    7 / 801 (0.87%)
         occurrences all number
    2
    7
    Ventricular extrasystoles
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Ventricular tachycardia
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Dementia
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    2
    4
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    3
    Dementia Alzheimer's type
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Dizziness
         subjects affected / exposed
    16 / 807 (1.98%)
    32 / 801 (4.00%)
         occurrences all number
    16
    32
    Headache
         subjects affected / exposed
    4 / 807 (0.50%)
    10 / 801 (1.25%)
         occurrences all number
    4
    10
    Hypoaesthesia
         subjects affected / exposed
    3 / 807 (0.37%)
    2 / 801 (0.25%)
         occurrences all number
    3
    2
    Normal pressure hydrocephalus
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Presyncope
         subjects affected / exposed
    3 / 807 (0.37%)
    5 / 801 (0.62%)
         occurrences all number
    3
    5
    Sciatica
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3
    Seizure
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Syncope
         subjects affected / exposed
    15 / 807 (1.86%)
    10 / 801 (1.25%)
         occurrences all number
    16
    10
    Cognitive disorder
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 807 (0.37%)
    10 / 801 (1.25%)
         occurrences all number
    3
    10
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    5 / 801 (0.62%)
         occurrences all number
    0
    5
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Splenomegaly
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    8 / 807 (0.99%)
    17 / 801 (2.12%)
         occurrences all number
    8
    17
    Vertigo positional
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Cerumen impaction
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Sudden hearing loss
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Eye disorders
    Cataract
         subjects affected / exposed
    5 / 807 (0.62%)
    2 / 801 (0.25%)
         occurrences all number
    6
    2
    Lacrimation increased
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Vision blurred
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Visual impairment
         subjects affected / exposed
    0 / 807 (0.00%)
    6 / 801 (0.75%)
         occurrences all number
    0
    6
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Abdominal pain upper
         subjects affected / exposed
    6 / 807 (0.74%)
    8 / 801 (1.00%)
         occurrences all number
    6
    8
    Constipation
         subjects affected / exposed
    5 / 807 (0.62%)
    7 / 801 (0.87%)
         occurrences all number
    5
    7
    Diarrhoea
         subjects affected / exposed
    9 / 807 (1.12%)
    11 / 801 (1.37%)
         occurrences all number
    11
    12
    Dyspepsia
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Dysphagia
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Gastritis
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 807 (0.37%)
    1 / 801 (0.12%)
         occurrences all number
    3
    1
    Nausea
         subjects affected / exposed
    4 / 807 (0.50%)
    10 / 801 (1.25%)
         occurrences all number
    4
    10
    Toothache
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    4 / 807 (0.50%)
    1 / 801 (0.12%)
         occurrences all number
    4
    1
    Hepatobiliary disorders
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Erythema
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3
    Pruritus
         subjects affected / exposed
    3 / 807 (0.37%)
    4 / 801 (0.50%)
         occurrences all number
    3
    4
    Rash
         subjects affected / exposed
    5 / 807 (0.62%)
    5 / 801 (0.62%)
         occurrences all number
    5
    6
    Skin ulcer
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3
    Rash pruritic
         subjects affected / exposed
    3 / 807 (0.37%)
    0 / 801 (0.00%)
         occurrences all number
    3
    0
    Urticaria
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Renal failure
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Urinary retention
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Chronic kidney disease
         subjects affected / exposed
    3 / 807 (0.37%)
    4 / 801 (0.50%)
         occurrences all number
    3
    4
    Acute kidney injury
         subjects affected / exposed
    8 / 807 (0.99%)
    6 / 801 (0.75%)
         occurrences all number
    8
    6
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Hypothyroidism
         subjects affected / exposed
    7 / 807 (0.87%)
    3 / 801 (0.37%)
         occurrences all number
    7
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 807 (0.62%)
    9 / 801 (1.12%)
         occurrences all number
    5
    10
    Arthritis
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Back pain
         subjects affected / exposed
    5 / 807 (0.62%)
    11 / 801 (1.37%)
         occurrences all number
    6
    12
    Bursitis
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Groin pain
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Joint swelling
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    2
    4
    Muscle spasms
         subjects affected / exposed
    0 / 807 (0.00%)
    5 / 801 (0.62%)
         occurrences all number
    0
    5
    Muscular weakness
         subjects affected / exposed
    3 / 807 (0.37%)
    3 / 801 (0.37%)
         occurrences all number
    3
    3
    Musculoskeletal pain
         subjects affected / exposed
    4 / 807 (0.50%)
    7 / 801 (0.87%)
         occurrences all number
    4
    7
    Myalgia
         subjects affected / exposed
    2 / 807 (0.25%)
    4 / 801 (0.50%)
         occurrences all number
    2
    4
    Osteoarthritis
         subjects affected / exposed
    1 / 807 (0.12%)
    7 / 801 (0.87%)
         occurrences all number
    1
    7
    Neck pain
         subjects affected / exposed
    3 / 807 (0.37%)
    2 / 801 (0.25%)
         occurrences all number
    3
    2
    Osteoporosis
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Polymyalgia rheumatica
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Pain in extremity
         subjects affected / exposed
    9 / 807 (1.12%)
    7 / 801 (0.87%)
         occurrences all number
    9
    7
    Rhabdomyolysis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Spinal column stenosis
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    12 / 807 (1.49%)
    9 / 801 (1.12%)
         occurrences all number
    12
    10
    Conjunctivitis
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Cellulitis
         subjects affected / exposed
    4 / 807 (0.50%)
    1 / 801 (0.12%)
         occurrences all number
    4
    1
    Cystitis
         subjects affected / exposed
    3 / 807 (0.37%)
    3 / 801 (0.37%)
         occurrences all number
    3
    3
    Erysipelas
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Fungal infection
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 807 (0.00%)
    4 / 801 (0.50%)
         occurrences all number
    0
    4
    Gastrointestinal infection
         subjects affected / exposed
    2 / 807 (0.25%)
    0 / 801 (0.00%)
         occurrences all number
    2
    0
    Gingivitis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Herpes zoster
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Infection
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    2
    3
    Influenza
         subjects affected / exposed
    3 / 807 (0.37%)
    4 / 801 (0.50%)
         occurrences all number
    3
    4
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 807 (0.25%)
    2 / 801 (0.25%)
         occurrences all number
    2
    2
    Nasopharyngitis
         subjects affected / exposed
    5 / 807 (0.62%)
    0 / 801 (0.00%)
         occurrences all number
    5
    0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 807 (0.00%)
    2 / 801 (0.25%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    10 / 807 (1.24%)
    5 / 801 (0.62%)
         occurrences all number
    10
    6
    Pulpitis dental
         subjects affected / exposed
    0 / 807 (0.00%)
    4 / 801 (0.50%)
         occurrences all number
    0
    4
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 807 (0.12%)
    2 / 801 (0.25%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    0 / 807 (0.00%)
    4 / 801 (0.50%)
         occurrences all number
    0
    4
    Urinary tract infection
         subjects affected / exposed
    19 / 807 (2.35%)
    30 / 801 (3.75%)
         occurrences all number
    21
    33
    Respiratory tract infection
         subjects affected / exposed
    1 / 807 (0.12%)
    3 / 801 (0.37%)
         occurrences all number
    1
    3
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    5 / 807 (0.62%)
    3 / 801 (0.37%)
         occurrences all number
    5
    3
    Diabetes mellitus
         subjects affected / exposed
    2 / 807 (0.25%)
    5 / 801 (0.62%)
         occurrences all number
    2
    5
    Gout
         subjects affected / exposed
    1 / 807 (0.12%)
    7 / 801 (0.87%)
         occurrences all number
    1
    8
    Hypokalaemia
         subjects affected / exposed
    2 / 807 (0.25%)
    3 / 801 (0.37%)
         occurrences all number
    3
    3
    Hyponatraemia
         subjects affected / exposed
    5 / 807 (0.62%)
    3 / 801 (0.37%)
         occurrences all number
    5
    3
    Decreased appetite
         subjects affected / exposed
    2 / 807 (0.25%)
    1 / 801 (0.12%)
         occurrences all number
    2
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 807 (0.00%)
    3 / 801 (0.37%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jun 2015
    Amendment 1, dated 25-Jun-2015: The first amendment occurred before start of the trial. Amendment 1 specified 2 minor modifications to remove the terms IMP and NIMP because of different local requirements in the participating countries, and to clarify the supply and labeling of clopidogrel, ASA, and VKA.
    17 Aug 2016
    Amendment 3, dated 17-Aug-2016, Amendment 3 mainly addressed changes in standard of care due to a changing clinical setting for the patient population in GALILEO, wording updates in the inclusion/exclusion criteria for clarification, removal of interim analysis and inferiority margin of safety analysis in the statistical analysis section.

    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.
    The study was terminated prematurely following a DSMB recommendation on 07-Aug-2018 to stop the study due to imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator. The study termination date was 13-Aug-2018.
    For support, Contact us.
    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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