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    Clinical Trial Results:
    Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

    Summary
    EudraCT number
    		 2007-001557-26
    Trial protocol
    		 GB   FR   SE   BE   DE   FI   ES   DK   CZ   AT   GR   PL   IT  
    Global end of trial date
    25 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Jun 2018
    First version publication date
    15 Jun 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CV185-048
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.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
    25 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with subjects with atrial fibrillation. The safety of this treatment was also studied. Three participants were missing age information from all study demographic tables, with no clear explanation about why data was missing. Because the system does not allow us to note missing information, the three participants of unknown age were added to the “Elderly (From 65-84 years)” age category.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Aug 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    South Africa: 147
    Country: Number of subjects enrolled
    Spain: 29
    Country: Number of subjects enrolled
    Sweden: 107
    Country: Number of subjects enrolled
    Taiwan: 91
    Country: Number of subjects enrolled
    Turkey: 30
    Country: Number of subjects enrolled
    Ukraine: 212
    Country: Number of subjects enrolled
    United Kingdom: 123
    Country: Number of subjects enrolled
    United States: 645
    Country: Number of subjects enrolled
    Argentina: 307
    Country: Number of subjects enrolled
    Australia: 56
    Country: Number of subjects enrolled
    Austria: 33
    Country: Number of subjects enrolled
    Belgium: 130
    Country: Number of subjects enrolled
    Brazil: 494
    Country: Number of subjects enrolled
    Canada: 325
    Country: Number of subjects enrolled
    Chile: 125
    Country: Number of subjects enrolled
    China: 256
    Country: Number of subjects enrolled
    Colombia: 50
    Country: Number of subjects enrolled
    Czech Republic: 182
    Country: Number of subjects enrolled
    Denmark: 23
    Country: Number of subjects enrolled
    Finland: 61
    Country: Number of subjects enrolled
    France: 87
    Country: Number of subjects enrolled
    Germany: 369
    Country: Number of subjects enrolled
    Greece: 28
    Country: Number of subjects enrolled
    Hong Kong: 44
    Country: Number of subjects enrolled
    India: 233
    Country: Number of subjects enrolled
    Indonesia: 140
    Country: Number of subjects enrolled
    Israel: 126
    Country: Number of subjects enrolled
    Italy: 119
    Country: Number of subjects enrolled
    Korea, Democratic People's Republic of: 145
    Country: Number of subjects enrolled
    Malaysia: 122
    Country: Number of subjects enrolled
    Mexico: 394
    Country: Number of subjects enrolled
    Norway: 17
    Country: Number of subjects enrolled
    Philippines: 134
    Country: Number of subjects enrolled
    Poland: 215
    Country: Number of subjects enrolled
    Russian Federation: 775
    Country: Number of subjects enrolled
    Singapore: 47
    Worldwide total number of subjects
    6421
    EEA total number of subjects
    1523
    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)
    1944
    From 65 to 84 years
    4010
    85 years and over
    467

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total 6421 subjects were enrolled in the study. Of these, 5598 were randomized (2807 to apixaban and 2791 to acetylsalicylic acid). Most (435) of the subjects who were not randomized (823) no longer met study criteria. Of those randomized, 5578 received treatment (2798 with apixaban, and 2780 with acetylsalicylic acid).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Apixaban, 2.5 or 5 mg Twice Daily
    Arm description
    		 Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban 5.0 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5.0 mg twice daily

    Investigational medicinal product name
    Apixaban 2.5 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg oral tablets twice daily

    Arm title
    		 Acetylsalicylic Acid, 81-324 mg Once Daily
    Arm description
    		 Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ASA 81 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ASA 81 mg oral tablets twice daily

    Number of subjects in period 1 [1]
    		Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Started
    2807
    2791
    Completed
    2798
    2780
    Not completed
    9
    11
         >=1 reason assigned per patient
    9
    11
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 6421 subjects were enrolled in the trial, of those 5578 received treatment.
    Period 2
    Period 2 title
    Double Blind
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Apixaban, 2.5 or 5 mg Twice Daily
    Arm description
    		 Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban 5.0 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5.0 mg twice daily

    Investigational medicinal product name
    Apixaban 2.5 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg oral tablets twice daily

    Arm title
    		 Acetylsalicylic Acid, 81-324 mg Once Daily
    Arm description
    		 Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ASA 81 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ASA 81 mg oral tablets twice daily

    Number of subjects in period 2
    		Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Started
    2798
    2780
    Completed
    2249
    2214
    Not completed
    549
    566
         >=1 reason assigned per patient
    549
    566
    Period 3
    Period 3 title
    Open Label
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Open Label Apixaban, 2.5 or 5 mg Twice Daily
    Arm description
    		 Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Apixaban 5.0 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5.0 mg twice daily

    Investigational medicinal product name
    Apixaban 2.5 mg oral tablets BID
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg oral tablets twice daily

    Number of subjects in period 3 [2]
    		Open Label Apixaban, 2.5 or 5 mg Twice Daily
    Started
    3275
    Completed
    2264
    Not completed
    1011
         >=1 reason assigned per patient
    1011
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: 1207 subjects discontinued the Double Blind treatment period 3275 entered the Open Label period. Subjects from both arms in the Double Blind treatment period were eligible to participate in the Open Label period.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Apixaban, 2.5 or 5 mg Twice Daily
    Reporting group description
    		 Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

    Reporting group title
    Acetylsalicylic Acid, 81-324 mg Once Daily
    Reporting group description
    		 Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

    Reporting group values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily Total
    Number of subjects
    		 2807 2791 5598
    Age, Customized
    Units: Subjects
        < 65 years
    		 855 865 1720
        >=65 but <75 years
    		 1049 938 1987
        >=75 years
    		 903 988 1891
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 69.7 ( 9.44 ) 70.0 ( 9.71 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 1147 1174 2321
        Male
    		 1660 1617 3277
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 6 6 12
        Asian
    		 541 544 1085
        Native Hawaiian or Other Pacific Islander
    		 3 1 4
        Black or African American
    		 10 26 36
        White
    		 2221 2178 4399
        Other
    		 26 36 62
    Number of Participants by Number of Risk Factors for Stroke
    Units: Subjects
        1 or fewer
    		 1085 1077 2162
        2 or more
    		 1722 1714 3436

    End points

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    End points reporting groups
    Reporting group title
    Apixaban, 2.5 or 5 mg Twice Daily
    Reporting group description
    		 Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

    Reporting group title
    Acetylsalicylic Acid, 81-324 mg Once Daily
    Reporting group description
    		 Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
    Reporting group title
    Apixaban, 2.5 or 5 mg Twice Daily
    Reporting group description
    		 Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.

    Reporting group title
    Acetylsalicylic Acid, 81-324 mg Once Daily
    Reporting group description
    		 Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.
    Reporting group title
    Open Label Apixaban, 2.5 or 5 mg Twice Daily
    Reporting group description
    		 Participants who completed the double-blind treatment period and met eligibility criteria had the option of enrolling in the Long Term Open Label Extension to receive open-label apixaban.

    Primary: Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period

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    End point title
    		 Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
    End point description
    Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)
    End point type
    Primary
    End point timeframe
    Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2807
    2791
    Units: Percentage of events
    number (not applicable)
        Stroke/Systemic Embolism Event Rate (%/yr)
    1.62
    3.63
    Statistical analysis title
    		 Stroke/Systemic Embolism
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 0.62

    Secondary: Event Rate for the Composite of Stroke of any type, Systemic Embolism, Myocardial Infarction, or Vascular Death during the double-blind treatment period

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    End point title
    		 Event Rate for the Composite of Stroke of any type, Systemic Embolism, Myocardial Infarction, or Vascular Death during the double-blind treatment period
    End point description
    Event rate=percent of participants with an event divided by the total participants in the arm.
    End point type
    Secondary
    End point timeframe
    Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2807
    2791
    Units: Percentage of events per year
    number (not applicable)
        Vascular death (n=84, 96) Event Rate (%/yr)
    4.21
    6.35
    Statistical analysis title
    		 Vascular Death
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.00026
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.83

    Secondary: Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death

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    End point title
    		 Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death
    End point description
    Event rate=percent of participants with an event divided by the total participants in the arm.
    End point type
    Secondary
    End point timeframe
    Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2807
    2791
    Units: Percentage of events per year
    number (not applicable)
        All-cause death (n=111, 140)|
    3.51
    4.42
        Net clinical benefit (n=163, 220)|
    5.23
    7.13
        Vascular death (n=84, 96)|
    2.65
    3.03
    Statistical analysis title
    		 All-Cause Death
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.06782
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.02
    Statistical analysis title
    		 Net-Clinical Benefit
    Statistical analysis description
    Composite of Major Vascular Events and Major Bleeding - net clinical benefit
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0028
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.9
    Statistical analysis title
    		 Vascular Death
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5598
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36586
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.17

    Secondary: Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period

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    End point title
    		 Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period
    End point description
    Event rate=percent of participants with an event divided by the total participants in the arm.
    End point type
    Secondary
    End point timeframe
    First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Percentage of events per year
    number (not applicable)
        Major bleeding Event Rate (%/yr)
    1.41
    0.92
        Major or CRNM bleeding Event Rate (%/yr)
    4.46
    3.24
        All bleeding Event Rate (%/yr)
    10.85
    8.32
    Statistical analysis title
    		 Major Bleeding
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5578
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0716
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 2.45
    Statistical analysis title
    		 All Bleeding
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5578
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0017
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.53
    Statistical analysis title
    		 Major or CRNM Bleeding
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5578
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0144
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.78

    Secondary: Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period

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    End point title
    		 Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period
    End point description
    Event rate=percent of participants with an event divided by the total participants in the arm.
    End point type
    Secondary
    End point timeframe
    Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Percentage of events per year
        number (not applicable)
    10.85
    8.32
    Statistical analysis title
    		 Unrefuted Bleeding
    Comparison groups
    Apixaban, 2.5 or 5 mg Twice Daily v Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects included in analysis
    5578
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0017
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.1
         upper limit
    		 1.53

    Secondary: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome

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    End point title
    		 Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome
    End point description
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
    End point type
    Secondary
    End point timeframe
    First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Participants
        AEs
    1833
    1925
        SAEs
    657
    804
        Bleeding AEs
    281
    259
        Discontinuations due to AE
    266
    362
        Deaths
    91
    115
    No statistical analyses for this end point

    Secondary: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 1 of 3)

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    End point title
    		 Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 1 of 3)
    End point description
    BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.
    End point type
    Secondary
    End point timeframe
    First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Participants
        Hemoglobin, low (n=1956, 1893)|
    131
    120
        Hemoglobin, high (n=1956, 1893)|
    0
    0
        Hematocrit, low (n=1728, 1687)|
    13
    9
        Hematocrit,high (n=1728, 1687)
    0
    0
        Erythrocytes, low (n=1728, 1687)|
    12
    12
        Erythrocytes, high (n=1728, 1687)|
    0
    0
        Platelet count, low (n=2148, 2098)|
    7
    10
        Platelet count, high (n=2148, 2098)|
    0
    0
        Leukocytes, low (n=1738, 1698)|
    12
    14
        Leukocytes, high (n=1738, 1698)|
    14
    18
        Neutrophils (absolute), low (n=2170, 2138)|
    2
    1
        Neutrophils (absolute), high (n=2170, 2138)|
    0
    0
        Eosinophils (absolute), low (n=2170, 2138)|
    0
    0
        Eosinophils (absolute), high (n=2170, 2138)|
    48
    68
        Basophils (absolute), low (n=2170, 2138)|
    0
    0
        Basophils (absolute), high (n=2170, 2138)|
    0
    0
        Monocytes (absolute), low (n=2170, 2138)|
    0
    0
        Monocytes (absolute), high (n=2170, 2138)|
    0
    2
        Lymphocytes (absolute), low (n=2170, 2138)|
    52
    62
        Lymphocytes (absolute), high (n=2170, 2138)|
    4
    5
        Alkaline phosphatase (ALP), low (n=2781, 2758)|
    0
    0
        ALP, high (n=2781, 2758)|
    34
    27
        Aspartate phosphatase (AST), low (n=2779, 2753)|
    0
    0
        AST, high (n=2779, 2753)|
    28
    33
        Alanine aminotransferase (ALT),low(n=2779,2753)
    0
    0
        ALT, high (n=2779, 2753)|
    23
    31
        Bilirubin (total), low (n=2781, 2758)|
    0
    0
        Bilirubin (total), high (n=2781, 2758)|
    30
    43
        Bilirubin (direct), low (n=2773, 2750)|
    0
    0
        Bilirubin (direct), high (n=2773, 2750)|
    241
    248
        Blood urea nitrogen (BUN), low (n=2201, 2172)|
    0
    0
        BUN, high (n=2201, 2172)|
    42
    50
        Creatinine, low (n=2209, 2178)|
    0
    0
        Creatinine, high (n=2209, 2178)|
    67
    71
    No statistical analyses for this end point

    Secondary: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 2 of 3)

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    End point title
    		 Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 2 of 3)
    End point description
    LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN
    End point type
    Secondary
    End point timeframe
    First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Participants
        Sodium (serum), low (n=1768, 1740)|
    2
    6
        Sodium (serum), high (n=1768, 1740)|
    1
    2
        Potassium (serum), low (n=1763, 1737)|
    6
    8
        Potassium (serum), high (n=1763, 1737)|
    20
    28
        Chloride (serum), low (n=1768, 1740)|
    0
    3
        Chloride (serum), high (n=1768, 1740)|
    0
    1
        Calcium (total), low (n=106, 109)|
    0
    0
        Calcium (total), high (n=106, 109)|
    0
    0
        Bicarbonate, low (n=1664, 1619)|
    0
    0
        Bicarbonate, high (n=1664, 1619)|
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 3 of 3)

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    End point title
    		 Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (part 3 of 3)
    End point description
    ULN=upper limit of normal; LLN=lower limit ofnormal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.
    End point type
    Secondary
    End point timeframe
    First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
    End point values
    		 Apixaban, 2.5 or 5 mg Twice Daily Acetylsalicylic Acid, 81-324 mg Once Daily
    Number of subjects analysed
    2798
    2780
    Units: Participants
        Creatine kinase, low (n=2780, 2758)|
    0
    0
        Creatine kinase, high (n=2780, 2758)|
    13
    25
        Protein (total), low (n=103, 109)|
    0
    0
        Protein (total), high (n=103, 109)|
    0
    0
        Uric acid, low (n=386, 390)|
    0
    0
        Uric acid, high (n=386, 390)|
    1
    0
        Glucose (urine), low (n=2, 3)|
    0
    0
        Glucose (urine), high (n=2, 3)|
    0
    1
        Protein (urine), low (n=3, 5)|
    0
    0
        Protein (urine), high (n=3, 5)|
    1
    1
        Blood (urine), low (n=3, 5)|
    0
    0
        Blood (urine), high (n=3, 5)|
    1
    0
        Leukocyte esterase (urine), low (n=3,5)|
    0
    0
        Leukocyte esterase (urine), high (n=3,5)|
    0
    0
        Red blood cells (RBC) (urine), low (n=2,2)|
    0
    0
        RBC (urine), high (n=2,2)|
    1
    0
        White blood cells (urine), low (n=2,2)|
    0
    0
        WBC (urine), high (n=2,2)|
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug (Day 1) to 30 days after last dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    DB-Apixaban
    Reporting group description
    		 Subjects received 5 milligram (mg) or 2.5 mg Apixaban orally as tablets (reduced dose for subjects deemed to be at increased risk of bleeding), twice a day (BID).

    Reporting group title
    OL-Apixaban
    Reporting group description
    		 Subjects received 5 mg or 2.5 mg Apixaban orally as tablets (reduced dose for subjects deemed to be at increased risk of bleeding), BID.

    Reporting group title
    DB-ASA
    Reporting group description
    		 Subjects received Acetylsalicylic Acid (ASA) 81 to 324 mg or matching placebo orally as tablet once a day.

    Serious adverse events
    		 DB-Apixaban OL-Apixaban DB-ASA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    679 / 2798 (24.27%)
    1252 / 3275 (38.23%)
    844 / 2780 (30.36%)
         number of deaths (all causes)
    111
    265
    140
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiosarcoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-Cell lymphoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-Cell small lymphocytic lymphoma stage iv
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 2798 (0.18%)
    12 / 3275 (0.37%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 12
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basosquamous carcinoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer stage 0, with cancer in situ
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm benign
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    9 / 2798 (0.32%)
    10 / 3275 (0.31%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    3 / 9
    5 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Carcinoid tumour of the caecum
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carcinoid tumour of the pancreas
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma stage 0
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    2 / 2798 (0.07%)
    6 / 3275 (0.18%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large b-cell lymphoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Gastric cancer
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic neoplasm malignant
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraocular melanoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyosarcoma metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Light chain disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liposarcoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    4 / 2798 (0.14%)
    17 / 3275 (0.52%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 4
    8 / 18
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Lymph node cancer metastatic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma stage i
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastases to abdominal cavity
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage iii
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Omentum neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    6 / 3275 (0.18%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Paraneoplastic syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    7 / 2798 (0.25%)
    13 / 3275 (0.40%)
    12 / 2780 (0.43%)
         occurrences causally related to treatment / all
    2 / 7
    6 / 14
    2 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer stage ii
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer stage iii
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sebaceous carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 2798 (0.07%)
    7 / 3275 (0.21%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    4 / 5
    2 / 8
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    3 / 2798 (0.11%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric cancer metastatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord neoplasm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic dissection
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic rupture
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial thrombosis limb
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis obliterans
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery embolism
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 5
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    6 / 3275 (0.18%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 6
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    4 / 2798 (0.14%)
    13 / 3275 (0.40%)
    9 / 2780 (0.32%)
         occurrences causally related to treatment / all
    3 / 4
    4 / 13
    4 / 10
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    6 / 2798 (0.21%)
    3 / 3275 (0.09%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 2798 (0.11%)
    5 / 3275 (0.15%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pallor
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic venous thrombosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein ruptured
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Venous insufficiency
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominoplasty
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioplasty
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anorectal operation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm repair
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve replacement
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign tumour excision
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder polypectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursa removal
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursal operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cancer surgery
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac ablation
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker battery replacement
         subjects affected / exposed
    3 / 2798 (0.11%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
         subjects affected / exposed
    4 / 2798 (0.14%)
    9 / 3275 (0.27%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker removal
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardioversion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid endarterectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choledochoenterostomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary angioplasty
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary arterial stent insertion
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endarterectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endovenous ablation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Explorative laparotomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye operation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fasciotomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric bypass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tube insertion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Genitourinary operation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoid operation
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve replacement
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia repair
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    High frequency ablation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip arthroplasty
         subjects affected / exposed
    2 / 2798 (0.07%)
    9 / 3275 (0.27%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip surgery
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hospitalisation
         subjects affected / exposed
    3 / 2798 (0.11%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis repair
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hysterectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implantable defibrillator insertion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implantable defibrillator replacement
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia repair
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia repair
         subjects affected / exposed
    4 / 2798 (0.14%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal anastomosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Knee arthroplasty
         subjects affected / exposed
    1 / 2798 (0.04%)
    6 / 3275 (0.18%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Knee operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laparotomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lithotripsy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mastectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device implantation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device removal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve repair
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve replacement
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchidectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreaticoduodenectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilloma excision
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery angioplasty
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plastic surgery to the face
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctocolectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic operation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal polypectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rehabilitation therapy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal stone removal
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin graft
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin lesion removal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin neoplasm excision
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fusion surgery
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tarsal tunnel decompression
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Therapeutic embolisation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thromboembolectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid operation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroidectomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toe amputation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth extraction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transfusion
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transurethral prostatectomy
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteral stent insertion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stent insertion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine dilation and curettage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventriculo-Peritoneal shunt
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebroplasty
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight loss diet
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist surgery
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Cephalhaematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 2798 (0.14%)
    9 / 3275 (0.27%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    1 / 1
    Chest discomfort
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    18 / 2798 (0.64%)
    29 / 3275 (0.89%)
    27 / 2780 (0.97%)
         occurrences causally related to treatment / all
    5 / 26
    5 / 31
    9 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Death
         subjects affected / exposed
    20 / 2798 (0.71%)
    48 / 3275 (1.47%)
    16 / 2780 (0.58%)
         occurrences causally related to treatment / all
    9 / 20
    17 / 48
    5 / 16
         deaths causally related to treatment / all
    7 / 17
    15 / 45
    4 / 15
    Device lead damage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device pacing issue
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    4 / 2798 (0.14%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Generalised oedema
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hernia pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site effusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-Organ failure
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    5 / 3275 (0.15%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Non-Cardiac chest pain
         subjects affected / exposed
    3 / 2798 (0.11%)
    2 / 3275 (0.06%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 2798 (0.07%)
    7 / 3275 (0.21%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 2798 (0.11%)
    7 / 3275 (0.21%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    3 / 2798 (0.11%)
    6 / 3275 (0.18%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 6
    1 / 1
         deaths causally related to treatment / all
    1 / 3
    3 / 6
    1 / 1
    Sudden death
         subjects affected / exposed
    13 / 2798 (0.46%)
    36 / 3275 (1.10%)
    15 / 2780 (0.54%)
         occurrences causally related to treatment / all
    4 / 13
    8 / 36
    5 / 15
         deaths causally related to treatment / all
    3 / 12
    7 / 33
    5 / 15
    Suprapubic pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Swelling
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Unevaluable event
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Activities of daily living impaired
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac assistance device user
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Physical assault
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 2798 (0.07%)
    8 / 3275 (0.24%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic hypoplasia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spermatic cord disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    6 / 2798 (0.21%)
    4 / 3275 (0.12%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    5 / 2798 (0.18%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Allergic bronchitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    6 / 2798 (0.21%)
    5 / 3275 (0.15%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Atelectasis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    12 / 2798 (0.43%)
    25 / 3275 (0.76%)
    11 / 2780 (0.40%)
         occurrences causally related to treatment / all
    2 / 12
    9 / 37
    3 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Cough
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    13 / 2798 (0.46%)
    24 / 3275 (0.73%)
    13 / 2780 (0.47%)
         occurrences causally related to treatment / all
    11 / 18
    3 / 28
    3 / 13
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    5 / 2798 (0.18%)
    16 / 3275 (0.49%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    4 / 5
    14 / 17
    6 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 2798 (0.11%)
    6 / 3275 (0.18%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    3 / 3
    6 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Lung infiltration
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinal mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 2798 (0.07%)
    6 / 3275 (0.18%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    3 / 2798 (0.11%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Pneumothorax
         subjects affected / exposed
    3 / 2798 (0.11%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    4 / 2798 (0.14%)
    9 / 3275 (0.27%)
    12 / 2780 (0.43%)
         occurrences causally related to treatment / all
    0 / 4
    3 / 9
    3 / 12
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 2798 (0.07%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary vascular disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory failure
         subjects affected / exposed
    4 / 2798 (0.14%)
    5 / 3275 (0.15%)
    12 / 2780 (0.43%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 6
    2 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    2 / 7
    Sinus polyp
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar i disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Confusional state
         subjects affected / exposed
    3 / 2798 (0.11%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paranoia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Lead dislodgement
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Cholecystitis
         subjects affected / exposed
    6 / 2798 (0.21%)
    4 / 3275 (0.12%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    2 / 6
    0 / 5
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    5 / 2798 (0.18%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    3 / 2798 (0.11%)
    7 / 3275 (0.21%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis fulminant
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatomegaly
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Portal hypertension
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Investigations
    Angiogram
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriogram coronary
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthroscopy
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood magnesium decreased
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystoscopy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ecg signs of myocardial ischaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart rate abnormal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage traumatic
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Confusion postoperative
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug toxicity
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eschar
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    4 / 2798 (0.14%)
    13 / 3275 (0.40%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 15
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    2 / 2798 (0.07%)
    8 / 3275 (0.24%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    5 / 2798 (0.18%)
    11 / 3275 (0.34%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 12
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    5 / 2798 (0.18%)
    12 / 3275 (0.37%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    In-Stent arterial restenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    In-Stent coronary artery restenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Jaw fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    8 / 3275 (0.24%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus lesion
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    3 / 2798 (0.11%)
    3 / 3275 (0.09%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 3
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital haematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural bile leak
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural diarrhoea
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Spinal column injury
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    4 / 2798 (0.14%)
    5 / 3275 (0.15%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    3 / 5
    4 / 5
    2 / 4
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    1 / 1
    Tendon rupture
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Therapeutic agent toxicity
         subjects affected / exposed
    3 / 2798 (0.11%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 2798 (0.00%)
    5 / 3275 (0.15%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic brain injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound secretion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liddle's syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    3 / 2798 (0.11%)
    7 / 3275 (0.21%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 7
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    13 / 2798 (0.46%)
    25 / 3275 (0.76%)
    19 / 2780 (0.68%)
         occurrences causally related to treatment / all
    3 / 13
    11 / 27
    6 / 21
         deaths causally related to treatment / all
    1 / 3
    2 / 6
    2 / 5
    Angina pectoris
         subjects affected / exposed
    5 / 2798 (0.18%)
    15 / 3275 (0.46%)
    9 / 2780 (0.32%)
         occurrences causally related to treatment / all
    0 / 5
    4 / 15
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    21 / 2798 (0.75%)
    17 / 3275 (0.52%)
    12 / 2780 (0.43%)
         occurrences causally related to treatment / all
    9 / 23
    4 / 17
    6 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Aortic valve incompetence
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    77 / 2798 (2.75%)
    114 / 3275 (3.48%)
    71 / 2780 (2.55%)
         occurrences causally related to treatment / all
    17 / 89
    37 / 169
    24 / 94
         deaths causally related to treatment / all
    1 / 1
    0 / 2
    1 / 1
    Atrial flutter
         subjects affected / exposed
    7 / 2798 (0.25%)
    8 / 3275 (0.24%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    4 / 8
    3 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 2798 (0.11%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    2 / 2798 (0.07%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    6 / 2798 (0.21%)
    11 / 3275 (0.34%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    4 / 2798 (0.14%)
    12 / 3275 (0.37%)
    9 / 2780 (0.32%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 12
    4 / 9
         deaths causally related to treatment / all
    1 / 2
    0 / 8
    3 / 7
    Cardiac asthma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    70 / 2798 (2.50%)
    120 / 3275 (3.66%)
    79 / 2780 (2.84%)
         occurrences causally related to treatment / all
    11 / 84
    31 / 179
    23 / 95
         deaths causally related to treatment / all
    0 / 4
    2 / 13
    1 / 3
    Cardiac failure acute
         subjects affected / exposed
    3 / 2798 (0.11%)
    3 / 3275 (0.09%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 2798 (0.00%)
    7 / 3275 (0.21%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
    Cardiac failure congestive
         subjects affected / exposed
    46 / 2798 (1.64%)
    55 / 3275 (1.68%)
    36 / 2780 (1.29%)
         occurrences causally related to treatment / all
    17 / 66
    26 / 73
    9 / 42
         deaths causally related to treatment / all
    1 / 5
    3 / 8
    0 / 0
    Cardio-Respiratory arrest
         subjects affected / exposed
    2 / 2798 (0.07%)
    9 / 3275 (0.27%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    2 / 7
    0 / 2
    Cardiogenic shock
         subjects affected / exposed
    1 / 2798 (0.04%)
    5 / 3275 (0.15%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    3 / 2798 (0.11%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Carditis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    4 / 2798 (0.14%)
    16 / 3275 (0.49%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
    9 / 18
    2 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Defect conduction intraventricular
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    3 / 2798 (0.11%)
    0 / 3275 (0.00%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    0 / 2798 (0.00%)
    7 / 3275 (0.21%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Microvascular angina
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    1 / 2798 (0.04%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    14 / 2798 (0.50%)
    25 / 3275 (0.76%)
    14 / 2780 (0.50%)
         occurrences causally related to treatment / all
    4 / 14
    5 / 25
    6 / 14
         deaths causally related to treatment / all
    1 / 4
    0 / 8
    2 / 3
    Myocardial ischaemia
         subjects affected / exposed
    3 / 2798 (0.11%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    4 / 2798 (0.14%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuropericarditis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatic heart disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    9 / 2798 (0.32%)
    0 / 3275 (0.00%)
    14 / 2780 (0.50%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 0
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 2798 (0.00%)
    18 / 3275 (0.55%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 19
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 2798 (0.11%)
    1 / 3275 (0.03%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    3 / 5
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular failure
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    3 / 2798 (0.11%)
    4 / 3275 (0.12%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Aphasia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Autonomic nervous system imbalance
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain stem haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Brain stem infarction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid arterial embolus
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar ataxia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral cyst
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    3 / 2798 (0.11%)
    10 / 3275 (0.31%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    8 / 10
    1 / 1
         deaths causally related to treatment / all
    2 / 2
    1 / 3
    1 / 1
    Cerebral infarction
         subjects affected / exposed
    2 / 2798 (0.07%)
    10 / 3275 (0.31%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    7 / 12
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cerebral microhaemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    17 / 2798 (0.61%)
    16 / 3275 (0.49%)
    44 / 2780 (1.58%)
         occurrences causally related to treatment / all
    6 / 17
    4 / 19
    14 / 45
         deaths causally related to treatment / all
    2 / 4
    0 / 3
    0 / 2
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical root pain
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Coma
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dementia alzheimer's type
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Dementia with lewy bodies
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 2798 (0.04%)
    6 / 3275 (0.18%)
    10 / 2780 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 6
    4 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    4 / 2798 (0.14%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    5 / 2798 (0.18%)
    8 / 3275 (0.24%)
    8 / 2780 (0.29%)
         occurrences causally related to treatment / all
    4 / 5
    7 / 8
    6 / 8
         deaths causally related to treatment / all
    0 / 1
    3 / 4
    0 / 0
    Headache
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemic encephalopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    24 / 2798 (0.86%)
    26 / 3275 (0.79%)
    51 / 2780 (1.83%)
         occurrences causally related to treatment / all
    11 / 27
    7 / 27
    27 / 55
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    1 / 3
    Lacunar infarction
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroglycopenia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    4 / 7
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve palsy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-Traumatic epilepsy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    5 / 2798 (0.18%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Subdural effusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    8 / 2798 (0.29%)
    26 / 3275 (0.79%)
    21 / 2780 (0.76%)
         occurrences causally related to treatment / all
    2 / 8
    4 / 27
    4 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombotic stroke
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    10 / 2798 (0.36%)
    13 / 3275 (0.40%)
    30 / 2780 (1.08%)
         occurrences causally related to treatment / all
    3 / 10
    3 / 13
    14 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uraemic encephalopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viith nerve paralysis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 2798 (0.43%)
    24 / 3275 (0.73%)
    11 / 2780 (0.40%)
         occurrences causally related to treatment / all
    11 / 18
    18 / 26
    7 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia megaloblastic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coagulopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic diathesis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 2798 (0.07%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 2798 (0.07%)
    6 / 3275 (0.18%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tolosa-Hunt syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    5 / 2798 (0.18%)
    6 / 3275 (0.18%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 6
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic polyp
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2798 (0.04%)
    6 / 3275 (0.18%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 7
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 2798 (0.00%)
    11 / 3275 (0.34%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 11
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Duodenitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    5 / 2798 (0.18%)
    3 / 3275 (0.09%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 3
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 2
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 2798 (0.14%)
    20 / 3275 (0.61%)
    11 / 2780 (0.40%)
         occurrences causally related to treatment / all
    3 / 4
    19 / 20
    7 / 11
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    1 / 1
    Gastrointestinal hypomotility
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival bleeding
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    3 / 2798 (0.11%)
    12 / 3275 (0.37%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 12
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 2798 (0.04%)
    6 / 3275 (0.18%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal ulcer
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    5 / 2798 (0.18%)
    5 / 3275 (0.15%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    5 / 5
    6 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal dilatation
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis ulcerative
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    8 / 2798 (0.29%)
    8 / 3275 (0.24%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    7 / 10
    8 / 8
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reflux oesophagitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spigelian hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic artery aneurysm
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth loss
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    15 / 3275 (0.46%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    12 / 16
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 2798 (0.07%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood blister
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis herpetiformis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Purpura
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash erythematous
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin lesion
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 2798 (0.00%)
    25 / 3275 (0.76%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    8 / 28
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
    Azotaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder mass
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    3 / 2798 (0.11%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    5 / 2798 (0.18%)
    13 / 3275 (0.40%)
    6 / 2780 (0.22%)
         occurrences causally related to treatment / all
    6 / 6
    9 / 14
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    1 / 2798 (0.04%)
    7 / 3275 (0.21%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 7
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    Renal failure acute
         subjects affected / exposed
    9 / 2798 (0.32%)
    0 / 3275 (0.00%)
    10 / 2780 (0.36%)
         occurrences causally related to treatment / all
    7 / 12
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure chronic
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral disorder
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 2798 (0.11%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid haemorrhage
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    7 / 2798 (0.25%)
    9 / 3275 (0.27%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal mass
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint swelling
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    4 / 3275 (0.12%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    11 / 2798 (0.39%)
    19 / 3275 (0.58%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 11
    4 / 20
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteopenia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plantar fasciitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon pain
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal wall abscess
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amoebic dysentery
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    6 / 3275 (0.18%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    2 / 2798 (0.07%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    7 / 2798 (0.25%)
    15 / 3275 (0.46%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    1 / 7
    3 / 16
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    3 / 2798 (0.11%)
    0 / 3275 (0.00%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Cellulitis
         subjects affected / exposed
    7 / 2798 (0.25%)
    13 / 3275 (0.40%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    1 / 7
    3 / 15
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Colonic abscess
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    7 / 3275 (0.21%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2798 (0.04%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endophthalmitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 2798 (0.00%)
    8 / 3275 (0.24%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 2798 (0.29%)
    15 / 3275 (0.46%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    3 / 17
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Groin infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic amoebiasis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis c
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis e
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Listeriosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Localised infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 2798 (0.07%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 6
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Lung infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    42 / 2798 (1.50%)
    104 / 3275 (3.18%)
    61 / 2780 (2.19%)
         occurrences causally related to treatment / all
    6 / 45
    23 / 120
    14 / 69
         deaths causally related to treatment / all
    1 / 5
    2 / 8
    0 / 2
    Pneumonia escherichia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia primary atypical
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoas abscess
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 2798 (0.04%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyometra
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 2798 (0.11%)
    6 / 3275 (0.18%)
    5 / 2780 (0.18%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    4 / 2798 (0.14%)
    18 / 3275 (0.55%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 19
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    2 / 5
    0 / 0
    Sepsis syndrome
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Septic shock
         subjects affected / exposed
    4 / 2798 (0.14%)
    14 / 3275 (0.43%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 14
    0 / 2
         deaths causally related to treatment / all
    1 / 2
    0 / 5
    0 / 1
    Sinusitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Tracheitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 2798 (0.11%)
    3 / 3275 (0.09%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    13 / 2798 (0.46%)
    24 / 3275 (0.73%)
    16 / 2780 (0.58%)
         occurrences causally related to treatment / all
    1 / 14
    3 / 26
    3 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 2798 (0.04%)
    4 / 3275 (0.12%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calciphylaxis
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    9 / 2798 (0.32%)
    11 / 3275 (0.34%)
    7 / 2780 (0.25%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 13
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    5 / 2798 (0.18%)
    7 / 3275 (0.21%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 7
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 2798 (0.00%)
    3 / 3275 (0.09%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes with hyperosmolarity
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 2798 (0.07%)
    1 / 3275 (0.03%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 2798 (0.11%)
    2 / 3275 (0.06%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    5 / 3275 (0.15%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    8 / 2798 (0.29%)
    12 / 3275 (0.37%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    2 / 10
    3 / 15
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    2 / 3275 (0.06%)
    3 / 2780 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 2798 (0.14%)
    6 / 3275 (0.18%)
    4 / 2780 (0.14%)
         occurrences causally related to treatment / all
    5 / 7
    2 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 2798 (0.00%)
    0 / 3275 (0.00%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    0 / 2798 (0.00%)
    1 / 3275 (0.03%)
    1 / 2780 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Starvation
         subjects affected / exposed
    1 / 2798 (0.04%)
    0 / 3275 (0.00%)
    0 / 2780 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 2798 (0.04%)
    2 / 3275 (0.06%)
    2 / 2780 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DB-Apixaban OL-Apixaban DB-ASA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    208 / 2798 (7.43%)
    276 / 3275 (8.43%)
    274 / 2780 (9.86%)
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    117 / 2798 (4.18%)
    129 / 3275 (3.94%)
    145 / 2780 (5.22%)
         occurrences all number
    127
    143
    161
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    107 / 2798 (3.82%)
    166 / 3275 (5.07%)
    148 / 2780 (5.32%)
         occurrences all number
    119
    188
    165

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Nov 2008
    To correct typographical errors in original protocol, to clarify protocol organization, language and definitions.
    30 Apr 2010
    Incorporates optional Long-Term Open-Label Extension (LTOLE)
    02 Nov 2010
    Changes applicable to LTOLE only: allows dose reduction, clarification to laboratory inclusion criteria and discontinuation of open-label apixaban
    22 Jun 2011
    Provides instructions to the Investigators if the result for the Serum Creatinine test fails to meet Exclusion Criteria at LTOLE entry or is above the alert high (AH) in the Clearstone lab report during ongoing therapy.
    24 Sep 2013
    Changes name of Medical Monitor and adds language regarding the Post Study Drug Access Program

    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.
    On May 28, 2010, after a planned interim analysis for efficacy, the Data Monitoring Committee recommended early termination due to apixaban's superior efficacy over ASA, with an acceptable safety profile. The open-label phase is ongoing.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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