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    Clinical Trial Results:
    Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk

    Summary
    EudraCT number
    2014-000305-13
    Trial protocol
    DK   HU   CZ   IT   ES   NL   LT   BG   GR   LV   AT   DE   GB   PT   SK   HR  
    Global end of trial date
    03 May 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    05 May 2019
    First version publication date
    05 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RIVAROXDVT3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02111564
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, United States, NJ 08869
    Public contact
    Clinical Registry group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen Research & Development LLC, ClinicalTrialsEU@its.jnj.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
    03 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the efficacy and safety of rivaroxaban, compared with placebo in the prevention of symptomatic venous thromboembolism events (lower extremity deep vein thrombosis [DVT] and non-fatal pulmonary embolism [PE]) and venous thromboembolism events-related death (death due to PE or death in which PE could not be ruled out as the cause) post hospital discharge in high-risk, medically ill subjects.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices (GCP) and applicable regulatory requirements. Safety assessments included adverse event and International Society on Thrombosis and Haemostasis (ISTH) major bleeding, non-major clinically relevant bleeding, other bleeding and clinical laboratory tests.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Jun 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
    Argentina: 242
    Country: Number of subjects enrolled
    Australia: 88
    Country: Number of subjects enrolled
    Austria: 14
    Country: Number of subjects enrolled
    Bulgaria: 1428
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 597
    Country: Number of subjects enrolled
    Belarus: 133
    Country: Number of subjects enrolled
    Brazil: 92
    Country: Number of subjects enrolled
    Canada: 43
    Country: Number of subjects enrolled
    Colombia: 140
    Country: Number of subjects enrolled
    Czech Republic: 231
    Country: Number of subjects enrolled
    Germany: 17
    Country: Number of subjects enrolled
    Denmark: 7
    Country: Number of subjects enrolled
    Spain: 383
    Country: Number of subjects enrolled
    Estonia: 11
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    Georgia: 1762
    Country: Number of subjects enrolled
    Greece: 131
    Country: Number of subjects enrolled
    Croatia: 270
    Country: Number of subjects enrolled
    Hungary: 549
    Country: Number of subjects enrolled
    Israel: 111
    Country: Number of subjects enrolled
    Italy: 147
    Country: Number of subjects enrolled
    Lithuania: 164
    Country: Number of subjects enrolled
    Latvia: 308
    Country: Number of subjects enrolled
    Mexico: 32
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 902
    Country: Number of subjects enrolled
    Netherlands: 17
    Country: Number of subjects enrolled
    Peru: 65
    Country: Number of subjects enrolled
    Poland: 619
    Country: Number of subjects enrolled
    Puerto Rico: 1
    Country: Number of subjects enrolled
    Portugal: 13
    Country: Number of subjects enrolled
    Romania: 324
    Country: Number of subjects enrolled
    Russian Federation: 1142
    Country: Number of subjects enrolled
    Serbia: 609
    Country: Number of subjects enrolled
    Turkey: 70
    Country: Number of subjects enrolled
    Ukraine: 854
    Country: Number of subjects enrolled
    United States: 290
    Country: Number of subjects enrolled
    South Africa: 205
    Worldwide total number of subjects
    12019
    EEA total number of subjects
    4641
    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)
    3655
    From 65 to 84 years
    7626
    85 years and over
    738

    Subject disposition

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    Recruitment
    Recruitment details
    This study was conducted from 10-June-2014 to 03-May-2018.

    Pre-assignment
    Screening details
    13708 subjects were screened for eligibility. Of these 12024 subjects were randomized (Rivaroxaban- 6007 and Placebo- 6017). 5 subjects in placebo were excluded from ITT population (2-invalid consent, 3 randomized prior to Health Authority approval).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Rivaroxaban 10 mg or 7.5 mg
    Arm description
    Subjects with a creatinine clearance (CrCl) at screening greater than or equal to (>=) 50 milliliter per minute (mL/min) at screening received 10 milligram (mg) rivaroxaban tablet once daily orally and subjects with a creatinine clearance at screening from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily for 45 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Rivaroxaban
    Investigational medicinal product code
    Other name
    JNJ-39039039, BAY 59-7939
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were randomised to receive 10 mg or 7.5 mg rivaroxaban tablet once daily for 45 days.

    Arm title
    Placebo
    Arm description
    Subjects received matching placebo tablet once daily for 45 days.
    Arm type
    Placebo comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo tablet once daily for 45 days.

    Number of subjects in period 1
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Started
    6007
    6012
    Safety
    5982
    5980
    Completed
    5876
    5869
    Not completed
    131
    143
         Adverse event, serious non-fatal
    6
    8
         Adverse event, serious fatal
    92
    99
         Adverse event, non serious
    11
    13
         Consent withdrawn by subject
    20
    20
         Lost to follow-up
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban 10 mg or 7.5 mg
    Reporting group description
    Subjects with a creatinine clearance (CrCl) at screening greater than or equal to (>=) 50 milliliter per minute (mL/min) at screening received 10 milligram (mg) rivaroxaban tablet once daily orally and subjects with a creatinine clearance at screening from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily for 45 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo tablet once daily for 45 days.

    Reporting group values
    Rivaroxaban 10 mg or 7.5 mg Placebo Total
    Number of subjects
    6007 6012 12019
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    1809 1846 3655
        From 65 to 84 years
    3866 3760 7626
        85 years and over
    332 406 738
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    69.7 ± 10.6 69.7 ± 10.22 -
    Title for Gender
    Units: subjects
        Male
    3130 3154 6284
        Female
    2877 2858 5735

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban 10 mg or 7.5 mg
    Reporting group description
    Subjects with a creatinine clearance (CrCl) at screening greater than or equal to (>=) 50 milliliter per minute (mL/min) at screening received 10 milligram (mg) rivaroxaban tablet once daily orally and subjects with a creatinine clearance at screening from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily for 45 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo tablet once daily for 45 days.

    Primary: Event Rate Based on the Time to the First Occurrence of Composite of all Symptomatic Venous Thromboembolism (VTE) and VTE-Related Death Adjudicated by Clinical Event Committee (CEC)

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    End point title
    Event Rate Based on the Time to the First Occurrence of Composite of all Symptomatic Venous Thromboembolism (VTE) and VTE-Related Death Adjudicated by Clinical Event Committee (CEC)
    End point description
    Symptomatic VTE included lower extremity deep vein thrombosis (DVT) and non-fatal pulmonary embolism (PE). Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. Intention-to-treat (ITT) analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Primary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    0.84
    1.11
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.136
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.76
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.52
         upper limit
    1.09

    Primary: Event Rate based on Time from Randomization to the First occurrence of Major Bleeding Adjudicated by CEC

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    End point title
    Event Rate based on Time from Randomization to the First occurrence of Major Bleeding Adjudicated by CEC
    End point description
    A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or last dose + 2 days. The Safety analysis set included all enrolled subjects in the ITT analysis set who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to 45 Days
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    5982
    5980
    Units: Events per 100 patients in 45 days
        number (not applicable)
    0.28
    0.15
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    11962
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.124
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.88
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.84
         upper limit
    4.23

    Secondary: Event Rate Based on Time from Randomization to an Occurrence of VTE-Related Death Adjudicated by CEC

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    End point title
    Event Rate Based on Time from Randomization to an Occurrence of VTE-Related Death Adjudicated by CEC
    End point description
    Time from randomization to an occurrence of VTE-related death was assessed. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. ITT analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    0.72
    0.77
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.751
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.62
         upper limit
    1.42

    Secondary: Event Rate Based on Time from Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC

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    End point title
    Event Rate Based on Time from Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
    End point description
    Time from randomization to the first occurrence of a symptomatic VTE was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. ITT analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    0.19
    0.42
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.023
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.44
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.22
         upper limit
    0.89

    Secondary: Event Rate Based on Time from Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC

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    End point title
    Event Rate Based on Time from Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC
    End point description
    Time from randomization to the first occurrence of a composite of symptomatic VTE and ACM was assessed. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. ITT analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    1.31
    1.80
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.033
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.54
         upper limit
    0.97

    Secondary: Event Rate Based on Time from Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC

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    End point title
    Event Rate Based on Time from Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC
    End point description
    Time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) was reported. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. ITT analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    1.58
    2.03
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.073
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.6
         upper limit
    1.02

    Secondary: Event Rate Based on Time from Randomization to an Occurrence of ACM Adjudicated by CEC

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    End point title
    Event Rate Based on Time from Randomization to an Occurrence of ACM Adjudicated by CEC
    End point description
    Time from randomization to an occurrence of all-cause mortality (ACM) was assessed. Event rate is defined as number of events per 100 subjects in 45 days of follow up. Subjects who did not have events are censored on the minimum of last visit before or on death, or Day 45. ITT analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Day 45
    End point values
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Number of subjects analysed
    6007
    6012
    Units: Events per 100 patients in 45 days
        number (not applicable)
    1.19
    1.49
    Statistical analysis title
    Statistical Analysis 1
    Comparison groups
    Rivaroxaban 10 mg or 7.5 mg v Placebo
    Number of subjects included in analysis
    12019
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.156
    Method
    Cox proportional hazards model
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.58
         upper limit
    1.09

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Approximately 80 days
    Adverse event reporting additional description
    Intention-to-treat (ITT) analysis set comprised all randomized subjects who signed a valid informed consent, regardless of actual treatment received.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Rivaroxaban 10 mg or 7.5 mg
    Reporting group description
    Subjects with a creatinine clearance (CrCl) at screening greater than or equal to (>=) 50 milliliter per minute (mL/min) at screening received 10 milligram (mg) rivaroxaban tablet once daily orally and subjects with a creatinine clearance at screening from >=30 to less than (<) 50 mL/min at screening received 7.5 mg rivaroxaban tablet once daily for 45 days.

    Reporting group title
    Placebo
    Reporting group description
    Subjects received matching placebo tablet once daily for 45 days.

    Serious adverse events
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    475 / 6007 (7.91%)
    493 / 6012 (8.20%)
         number of deaths (all causes)
    115
    126
         number of deaths resulting from adverse events
    Vascular disorders
    Aortic Dissection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Stenosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Distributive Shock
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    0 / 6007 (0.00%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    5 / 6007 (0.08%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Occlusion
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Thrombotic Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Leukaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma of Colon
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer Recurrent
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neoplasm
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Neoplasm
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic Cancer Metastatic
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung Infiltration Malignant
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    0 / 6007 (0.00%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Malignant Neoplasm of Unknown Primary Site
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant Pleural Effusion
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinum Neoplasm
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Neoplasm
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Neoplasm
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid Cancer
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Neoplasm
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Bereavement
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immobile
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    25 / 6007 (0.42%)
    30 / 6012 (0.50%)
         occurrences causally related to treatment / all
    1 / 25
    0 / 30
         deaths causally related to treatment / all
    1 / 25
    0 / 30
    Fatigue
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oedema Peripheral
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Swelling
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 6007 (0.00%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Cardiac Death
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion Disorder
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    0 / 6007 (0.00%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Anastomosis Complication
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nerve Injury
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pneumothorax
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Injury
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Injury
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to Various Agents
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Lung Injury
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Twiddler's Syndrome
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspiration Bronchial
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body Temperature Increased
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Output Decreased
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Necrosis Marker Increased
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Left Ventricular Failure
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    3 / 6007 (0.05%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    13 / 6007 (0.22%)
    10 / 6012 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    3 / 6007 (0.05%)
    6 / 6012 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    4 / 6007 (0.07%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    5 / 6007 (0.08%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Cardiac Asthma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    51 / 6007 (0.85%)
    62 / 6012 (1.03%)
         occurrences causally related to treatment / all
    0 / 53
    0 / 69
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Cardiac Failure Acute
         subjects affected / exposed
    14 / 6007 (0.23%)
    14 / 6012 (0.23%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 15
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiac Failure Chronic
         subjects affected / exposed
    13 / 6007 (0.22%)
    8 / 6012 (0.13%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    24 / 6007 (0.40%)
    25 / 6012 (0.42%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 26
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Cardiac Valve Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Ventricular Thrombosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    5 / 6007 (0.08%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Cardiogenic Shock
         subjects affected / exposed
    4 / 6007 (0.07%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cardiomyopathy
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiomyopathy Acute
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiopulmonary Failure
         subjects affected / exposed
    4 / 6007 (0.07%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Congestive Cardiomyopathy
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastolic Dysfunction
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Interventricular Septum Rupture
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    4 / 6007 (0.07%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Fibrosis
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Myocarditis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nodal Rhythm
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right Ventricular Failure
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 6007 (0.02%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    3 / 6007 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    4 / 6007 (0.07%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Respiratory Failure
         subjects affected / exposed
    7 / 6007 (0.12%)
    9 / 6012 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Asthma
         subjects affected / exposed
    8 / 6007 (0.13%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchitis Chronic
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 6007 (0.02%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    81 / 6007 (1.35%)
    77 / 6012 (1.28%)
         occurrences causally related to treatment / all
    0 / 88
    0 / 87
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Chronic Respiratory Failure
         subjects affected / exposed
    4 / 6007 (0.07%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 6007 (0.02%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lupus Pleurisy
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    2 / 6007 (0.03%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    3 / 6007 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Spontaneous
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Arterial Hypertension
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Congestion
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Fibrosis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    1 / 6007 (0.02%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary Pneumatocele
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    9 / 6007 (0.15%)
    8 / 6012 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 6007 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune Haemolytic Anaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carotid Artery Occlusion
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocervical Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelinating Polyneuropathy
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Coma
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoglycaemic Encephalopathy
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Intolerance
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 6007 (0.10%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Encephalopathy
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Artery Stenosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS Origin
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctival Oedema
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exophthalmos
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Artery Occlusion
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Motion Sickness
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Incarcerated Hernia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Abdomen
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    3 / 6007 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    2 / 6007 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 6007 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Haemorrhagic
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Polyps
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Inguinal Hernia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Disorder
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    2 / 6007 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer Haemorrhage
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer Perforation
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Polyp
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    7 / 6007 (0.12%)
    8 / 6012 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketonuria
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    3 / 6007 (0.05%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Impairment
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    3 / 6007 (0.05%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Obstruction
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    2 / 6007 (0.03%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 6007 (0.03%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Lesion
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Allergic
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Necrosis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitic Ulcer
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device Dislocation
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Failure
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Occlusion
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment Syndrome
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid Arthritis
         subjects affected / exposed
    1 / 6007 (0.02%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Lesion
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    2 / 6007 (0.03%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Metabolic Decompensation
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to Thrive
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 6007 (0.02%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    3 / 6007 (0.05%)
    5 / 6012 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overweight
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cellulitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    5 / 6007 (0.08%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary Aspergillosis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    11 / 6007 (0.18%)
    10 / 6012 (0.17%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic Foot Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocarditis Bacterial
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endotoxic Shock
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 6007 (0.05%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal Oesophagitis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal Skin Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    2 / 6007 (0.03%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Salmonella
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Helicobacter Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Colitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Pleural Effusion
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation of Bronchiectasis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation of Chronic Obstructive Airways Disease
         subjects affected / exposed
    1 / 6007 (0.02%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Spondylitis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 6007 (0.02%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection Site Abscess
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    58 / 6007 (0.97%)
    48 / 6012 (0.80%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 49
         deaths causally related to treatment / all
    0 / 7
    0 / 5
    Pneumonia Bacterial
         subjects affected / exposed
    2 / 6007 (0.03%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia Pseudomonal
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 6007 (0.00%)
    2 / 6012 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyoderma
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    3 / 6007 (0.05%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 6007 (0.07%)
    3 / 6012 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Septic Shock
         subjects affected / exposed
    1 / 6007 (0.02%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Sinusitis
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Infection
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic Abscess
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Bacteraemia
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    2 / 6007 (0.03%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous Pleurisy
         subjects affected / exposed
    0 / 6007 (0.00%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 6007 (0.03%)
    1 / 6012 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    11 / 6007 (0.18%)
    11 / 6012 (0.18%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 6007 (0.00%)
    4 / 6012 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Viral Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection Staphylococcal
         subjects affected / exposed
    1 / 6007 (0.02%)
    0 / 6012 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    Rivaroxaban 10 mg or 7.5 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    250 / 6007 (4.16%)
    280 / 6012 (4.66%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    75 / 6007 (1.25%)
    93 / 6012 (1.55%)
         occurrences all number
    81
    101
    Nervous system disorders
    Headache
         subjects affected / exposed
    114 / 6007 (1.90%)
    147 / 6012 (2.45%)
         occurrences all number
    137
    174
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    69 / 6007 (1.15%)
    52 / 6012 (0.86%)
         occurrences all number
    80
    53

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Jun 2015
    The overall reason for amendment INT-5 was to modify study procedures, clarify eligibility criteria (including the risk score criterion), and to add subject training materials.
    19 Jun 2015
    The overall reason for amendment INT-6 was to clarify prescribed maximum daily dose of thromboprophylactic agents during index hospitalization and to clarify capping of subgroups with certain baseline characteristics or by geographic region or country during enrollment.
    31 Mar 2017
    The overall reason for amendment INT-7 was to increase the maximum number of subjects allowed to be enrolled due to a lower than expected blinded pooled event rate in this event driven study.

    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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