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    Clinical Trial Results:
    Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism

    Summary
    EudraCT number
    2013-000619-26
    Trial protocol
    BE   SE   AT   IT   ES   GB   CZ   DE   HU   DK   NL   NO   PL  
    Global end of trial date
    04 Nov 2016

    Results information
    Results version number
    v2(current)
    This version publication date
    17 Feb 2019
    First version publication date
    08 Nov 2017
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Control of data.

    Trial information

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    Trial identification
    Sponsor protocol code
    BAY59-7939/16416
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02064439
    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
    04 Nov 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Nov 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to acetylsalicylic acid (ASA) 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism). The secondary efficacy objective is to evaluate whether rivaroxaban 10 mg and rivaroxaban 20 mg are superior to ASA 100 mg in the prevention of the secondary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism, myocardial infarction, ischemic stroke, systemic non-CNS embolism).
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent form was read by and explained to all 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
    05 Mar 2014
    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
    Australia: 76
    Country: Number of subjects enrolled
    Austria: 28
    Country: Number of subjects enrolled
    Belgium: 81
    Country: Number of subjects enrolled
    Brazil: 88
    Country: Number of subjects enrolled
    Canada: 154
    Country: Number of subjects enrolled
    China: 323
    Country: Number of subjects enrolled
    Czech Republic: 203
    Country: Number of subjects enrolled
    Denmark: 152
    Country: Number of subjects enrolled
    France: 516
    Country: Number of subjects enrolled
    Germany: 142
    Country: Number of subjects enrolled
    Hungary: 80
    Country: Number of subjects enrolled
    Israel: 75
    Country: Number of subjects enrolled
    Italy: 104
    Country: Number of subjects enrolled
    Mexico: 23
    Country: Number of subjects enrolled
    Netherlands: 250
    Country: Number of subjects enrolled
    New Zealand: 62
    Country: Number of subjects enrolled
    Norway: 14
    Country: Number of subjects enrolled
    Philippines: 4
    Country: Number of subjects enrolled
    Poland: 23
    Country: Number of subjects enrolled
    Russian Federation: 368
    Country: Number of subjects enrolled
    South Africa: 143
    Country: Number of subjects enrolled
    Korea, Republic of: 62
    Country: Number of subjects enrolled
    Spain: 111
    Country: Number of subjects enrolled
    Sweden: 67
    Country: Number of subjects enrolled
    Switzerland: 37
    Country: Number of subjects enrolled
    Taiwan: 35
    Country: Number of subjects enrolled
    Thailand: 28
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    United Kingdom: 24
    Country: Number of subjects enrolled
    United States: 70
    Country: Number of subjects enrolled
    Vietnam: 14
    Worldwide total number of subjects
    3365
    EEA total number of subjects
    1795
    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)
    2053
    From 65 to 84 years
    1262
    85 years and over
    50

    Subject disposition

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    Recruitment
    Recruitment details
    In total 3439 subjects were screened at 244 sites in 31 countries from 05-Mar-2014 (First Patient First Visit) to 15-Mar-2016 (Last Patient First Visit).

    Pre-assignment
    Screening details
    Of the 3439 subjects screened 43 did not complete screening. Thus, 3396 subjects were randomly assigned to treatment, 31 of the randomized subjects never received study medication because either withdrew consent or were withdrawn from the study based on protocol violations.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD
    Arm description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.
    Arm type
    Experimental

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

    Arm title
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Arm description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.
    Arm type
    Experimental

    Investigational medicinal product name
    Rivaroxaban (Xarelto)
    Investigational medicinal product code
    BAY59-7939
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    20 mg tablet, OD

    Arm title
    Acetylsalicylic (ASA) 100 mg, OD
    Arm description
    Subjects were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.
    Arm type
    Active comparator

    Investigational medicinal product name
    Acetylsalicylic (ASA)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg tablet, OD

    Number of subjects in period 1
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
    Started
    1127
    1107
    1131
    Completed
    984
    969
    949
    Not completed
    143
    138
    182
         Adverse event, serious fatal
    -
    2
    3
         Consent withdrawn by subject
    29
    18
    26
         Physician decision
    -
    1
    1
         Logistical difficulties
    6
    5
    2
         Adverse event, non-fatal
    51
    47
    46
         Safety outcome reached
    12
    20
    10
         Other
    2
    2
    7
         Non-compliance with study medication
    21
    19
    23
         Efficacy outcome reached
    18
    16
    57
         Lost to follow-up
    1
    3
    4
         Protocol deviation
    3
    5
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Acetylsalicylic (ASA) 100 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group values
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD Total
    Number of subjects
    1127 1107 1131 3365
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    678 691 684 2053
        From 65-75 years
    316 301 301 918
        75 years and over
    133 115 146 394
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    58.8 ( 14.7 ) 57.9 ( 14.7 ) 58.8 ( 14.7 ) -
    Gender Categorical
    Units: Subjects
        Female
    507 505 488 1500
        Male
    620 602 643 1865
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    31 31 30 92
        Not Hispanic or Latino
    892 899 889 2680
        Unknown or Not Reported
    204 177 212 593
    Race
    Units: Subjects
        American Indian or Alaska Native
    2 0 2 4
        Asian
    161 159 159 479
        Native Hawaiian or Other Pacific Islander
    1 1 2 4
        Black or African American
    41 49 36 126
        White
    786 772 786 2344
        More than one race
    1 0 5 6
        Unknown or Not Reported
    135 126 141 402
    Subject analysis sets

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set (FAS) includes all randomized subjects who received at least one dose of study medication.

    Subject analysis sets values
    FAS
    Number of subjects
    3365
    Age Categorical
    Units: Subjects
        Adults (18-64 years)
    2053
        From 65-75 years
    918
        75 years and over
    364
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    58.5 ( 14.7 )
    Gender Categorical
    Units: Subjects
        Female
    1500
        Male
    1865
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    2680
        Not Hispanic or Latino
    92
        Unknown or Not Reported
    593
    Race
    Units: Subjects
        American Indian or Alaska Native
    4
        Asian
    479
        Native Hawaiian or Other Pacific Islander
    4
        Black or African American
    126
        White
    2344
        More than one race
    6
        Unknown or Not Reported
    402

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Acetylsalicylic (ASA) 100 mg, OD
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Subject analysis set title
    FAS
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Full analysis set (FAS) includes all randomized subjects who received at least one dose of study medication.

    Primary: Number of subjects with the composite of fatal or non-fatal symptomatic recurrent venous thromboembolism

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    End point title
    Number of subjects with the composite of fatal or non-fatal symptomatic recurrent venous thromboembolism
    End point description
    The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    End point values
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects analysed
    1127
    1107
    1131
    Units: subjects
        Composite
    13
    17
    50
        Symptomatic recurrent Deep vein thrombosis (DVT)
    8
    9
    29
        Symptomatic recurrent PE
    5
    6
    19
        Death (PE)
    0
    0
    1
        Death (unexplained and PE cannot be ruled out)
    0
    2
    1
    Statistical analysis title
    Rivaroxaban 20 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2238
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0001 [1]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.59
    Notes
    [1] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 10 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2258
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [2]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.26
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.14
         upper limit
    0.47
    Notes
    [2] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 20 mg vs. Rivaroxaban 10 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Number of subjects included in analysis
    2234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.4328 [3]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.65
         upper limit
    2.75
    Notes
    [3] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).

    Primary: Number of subjects with first treatment-emergent major bleeding

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    End point title
    Number of subjects with first treatment-emergent major bleeding
    End point description
    The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    End point values
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects analysed
    1127
    1107
    1131
    Units: subjects
        Any major bleeding
    5
    6
    3
        Fatal bleeding
    0
    1
    1
        Non-fatal critical organ bleed
    2
    4
    1
        Non-fatal non-critical organ bleeding
    3
    1
    1
    Statistical analysis title
    Rivaroxaban 20 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2238
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3235 [4]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.01
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.5
         upper limit
    8.04
    Notes
    [4] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 20 mg vs. Rivaroxaban 10 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2258
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.5005 [5]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.64
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.39
         upper limit
    6.84
    Notes
    [5] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 20 mg vs. Rivaroxaban 10 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Number of subjects included in analysis
    2234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7337 [6]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.23
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.37
         upper limit
    4.03
    Notes
    [6] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).

    Secondary: Number of subjects with the composite of the primary efficacy outcome, myocardial infarction, ischemic stroke or systemic non-CNS embolism

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    End point title
    Number of subjects with the composite of the primary efficacy outcome, myocardial infarction, ischemic stroke or systemic non-CNS embolism
    End point description
    The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects analysed
    1127
    1107
    1131
    Units: subjects
        Composite
    18
    19
    56
        Ischemic stroke
    4
    2
    2
        Non-CNS systemic embolism
    1
    0
    1
        Myocardial infarction
    0
    1
    4
        Symptomatic recurrent DVT
    8
    9
    29
        Symptomatic recurrent PE
    5
    6
    18
        Death (PE)
    0
    0
    1
        Death (unexplained and PE cannot be ruled out)
    0
    1
    1
        Death (cardiovascular: myocardial infarction)
    0
    0
    0
        Death (cardiovascular: ischemic stroke)
    0
    0
    0
    Statistical analysis title
    Rivaroxaban 20 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2238
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [7]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.34
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.57
    Notes
    [7] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 10 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2258
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001 [8]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.19
         upper limit
    0.54
    Notes
    [8] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 20 mg vs. Rivaroxaban 10 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Number of subjects included in analysis
    2234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.8172 [9]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.57
         upper limit
    2.06
    Notes
    [9] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).

    Secondary: Number of subjects with non-major bleeding associated with study drug interruption for > 14 days

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    End point title
    Number of subjects with non-major bleeding associated with study drug interruption for > 14 days
    End point description
    The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects analysed
    1127
    1107
    1131
    Units: subjects
    12
    17
    12
    Statistical analysis title
    Rivaroxaban 20 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2238
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3318 [10]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.69
         upper limit
    3.02
    Notes
    [10] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 10 mg vs. ASA 100 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Acetylsalicylic (ASA) 100 mg, OD
    Number of subjects included in analysis
    2258
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.9726 [11]
    Method
    Wald test
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    2.2
    Notes
    [11] - P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).
    Statistical analysis title
    Rivaroxaban 20 mg vs. Rivaroxaban 10 mg
    Comparison groups
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD v Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD
    Number of subjects included in analysis
    2234
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.3137
    Method
    Wald te
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.46
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.7
         upper limit
    3.06

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From after start of study medication but not more than 2 days after stop of study medication.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Rivaroxaban (Xarelto, BAY59-7939) 20 mg
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Reporting group title
    Acetylsalicylic (ASA) 100 mg
    Reporting group description
    Subjects were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all subjects stopped 6 months after the last subject was randomized.

    Serious adverse events
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg Rivaroxaban (Xarelto, BAY59-7939) 20 mg Acetylsalicylic (ASA) 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    78 / 1127 (6.92%)
    82 / 1107 (7.41%)
    79 / 1131 (6.98%)
         number of deaths (all causes)
    3
    10
    7
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma recurrent
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyosarcoma
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Malignant melanoma stage I
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma stage IV
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Meningioma
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal carcinoma stage 0
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer recurrent
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    3 / 1127 (0.27%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix warts
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant glioma
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer stage IV
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hysterectomy
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma surgery
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Overlap syndrome
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 1127 (0.09%)
    3 / 1107 (0.27%)
    3 / 1131 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 1127 (0.09%)
    2 / 1107 (0.18%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    3 / 1127 (0.27%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Cystoscopy
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-lymphocyte count increased
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    3 / 1131 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    3 / 1131 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 1127 (0.18%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 1127 (0.09%)
    3 / 1107 (0.27%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Axonal neuropathy
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    2 / 1127 (0.18%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1127 (0.00%)
    2 / 1107 (0.18%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1127 (0.00%)
    2 / 1107 (0.18%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Corneal degeneration
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1127 (0.09%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1127 (0.09%)
    2 / 1107 (0.18%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic anal papilla
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eosinophilic oesophagitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon dysplasia
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seborrhoea
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pruritus generalised
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cutaneous lupus erythematosus
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 1127 (0.18%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute kidney injury
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Cushing's syndrome
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint ankylosis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 1127 (0.27%)
    0 / 1107 (0.00%)
    5 / 1131 (0.44%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    0 / 1127 (0.00%)
    2 / 1107 (0.18%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    2 / 1107 (0.18%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    2 / 1127 (0.18%)
    0 / 1107 (0.00%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 1127 (0.18%)
    1 / 1107 (0.09%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasmodium falciparum infection
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 1127 (0.18%)
    5 / 1107 (0.45%)
    3 / 1131 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelitis
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 1127 (0.00%)
    0 / 1107 (0.00%)
    1 / 1131 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1127 (0.09%)
    3 / 1107 (0.27%)
    2 / 1131 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Urethral abscess
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 1127 (0.18%)
    4 / 1107 (0.36%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 1127 (0.00%)
    2 / 1107 (0.18%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Borrelia infection
         subjects affected / exposed
    1 / 1127 (0.09%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 1127 (0.00%)
    1 / 1107 (0.09%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    2 / 1127 (0.18%)
    0 / 1107 (0.00%)
    0 / 1131 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0.3%
    Non-serious adverse events
    Rivaroxaban (Xarelto, BAY59-7939) 10 mg Rivaroxaban (Xarelto, BAY59-7939) 20 mg Acetylsalicylic (ASA) 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    40 / 1127 (3.55%)
    35 / 1107 (3.16%)
    38 / 1131 (3.36%)
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    6 / 1127 (0.53%)
    2 / 1107 (0.18%)
    3 / 1131 (0.27%)
         occurrences all number
    6
    2
    3
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 1127 (0.35%)
    4 / 1107 (0.36%)
    3 / 1131 (0.27%)
         occurrences all number
    5
    4
    3
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 1127 (0.18%)
    2 / 1107 (0.18%)
    5 / 1131 (0.44%)
         occurrences all number
    3
    2
    5
    Constipation
         subjects affected / exposed
    2 / 1127 (0.18%)
    0 / 1107 (0.00%)
    7 / 1131 (0.62%)
         occurrences all number
    2
    0
    8
    Diarrhoea
         subjects affected / exposed
    4 / 1127 (0.35%)
    4 / 1107 (0.36%)
    1 / 1131 (0.09%)
         occurrences all number
    4
    5
    1
    Dyspepsia
         subjects affected / exposed
    1 / 1127 (0.09%)
    3 / 1107 (0.27%)
    4 / 1131 (0.35%)
         occurrences all number
    1
    3
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 1127 (0.09%)
    5 / 1107 (0.45%)
    6 / 1131 (0.53%)
         occurrences all number
    1
    5
    6
    Vomiting
         subjects affected / exposed
    0 / 1127 (0.00%)
    4 / 1107 (0.36%)
    2 / 1131 (0.18%)
         occurrences all number
    0
    4
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    5 / 1127 (0.44%)
    3 / 1107 (0.27%)
    3 / 1131 (0.27%)
         occurrences all number
    5
    3
    3
    Pruritus
         subjects affected / exposed
    8 / 1127 (0.71%)
    3 / 1107 (0.27%)
    3 / 1131 (0.27%)
         occurrences all number
    8
    3
    3
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 1127 (0.27%)
    3 / 1107 (0.27%)
    4 / 1131 (0.35%)
         occurrences all number
    3
    3
    4
    Myalgia
         subjects affected / exposed
    2 / 1127 (0.18%)
    2 / 1107 (0.18%)
    4 / 1131 (0.35%)
         occurrences all number
    2
    2
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 1127 (0.35%)
    2 / 1107 (0.18%)
    0 / 1131 (0.00%)
         occurrences all number
    4
    2
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 1127 (0.09%)
    4 / 1107 (0.36%)
    3 / 1131 (0.27%)
         occurrences all number
    1
    6
    4

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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

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