Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multinational, Randomised, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus

    Summary
    EudraCT number
    2013-003519-23
    Trial protocol
    HU   CZ   SK   SE   NL   DE   IT   GB   ES   NO   AT   DK   BE   FI   BG   FR  
    Global end of trial date
    16 Feb 2019

    Results information
    Results version number
    v2(current)
    This version publication date
    06 May 2020
    First version publication date
    26 Jan 2020
    Other versions
    v1
    Version creation reason

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    D513BC00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01991795
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, 43183
    Public contact
    Global Clinical Lead, Study Information center, +1 877 240 9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, Study Information center, +1 877 240 9479, information.center@astrazeneca.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
    16 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Feb 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the effect of long-term treatment with ticagrelor twice daily (bd) vs. placebo for the prevention of major cardiovascular (CV) events (composite of CV death, myocardial infarction [MI] or stroke) in patients with Type 2 Diabetes Mellitus (T2DM) at high risk for CV events, but without a previous medical history of MI or stroke. The primary efficacy variable is time from randomisation to first occurrence of any event from the composite of CV death, MI or stroke (ischaemic, haemorrhagic or unknown etiology).
    Protection of trial subjects
    Treated in routine care, on a background therapy of acetylsalicylic acid (ASA).
    Background therapy
    Patients should be treated with low-dose acetylsalicylic acid (ASA) unless contraindicated or not tolerated, in accordance with national and international clinical practice guidelines.
    Evidence for comparator
    -
    Actual start date of recruitment
    10 Feb 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    40 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 1636
    Country: Number of subjects enrolled
    Russian Federation: 1121
    Country: Number of subjects enrolled
    Argentina: 394
    Country: Number of subjects enrolled
    Australia: 188
    Country: Number of subjects enrolled
    Austria: 87
    Country: Number of subjects enrolled
    Belgium: 217
    Country: Number of subjects enrolled
    Bulgaria: 878
    Country: Number of subjects enrolled
    Brazil: 811
    Country: Number of subjects enrolled
    Canada: 729
    Country: Number of subjects enrolled
    Chile: 300
    Country: Number of subjects enrolled
    China: 910
    Country: Number of subjects enrolled
    Colombia: 136
    Country: Number of subjects enrolled
    Czech Republic: 602
    Country: Number of subjects enrolled
    Denmark: 243
    Country: Number of subjects enrolled
    Germany: 547
    Country: Number of subjects enrolled
    Spain: 340
    Country: Number of subjects enrolled
    Finland: 118
    Country: Number of subjects enrolled
    France: 172
    Country: Number of subjects enrolled
    United Kingdom: 246
    Country: Number of subjects enrolled
    Hong Kong: 152
    Country: Number of subjects enrolled
    Hungary: 616
    Country: Number of subjects enrolled
    India: 292
    Country: Number of subjects enrolled
    Israel: 117
    Country: Number of subjects enrolled
    Italy: 130
    Country: Number of subjects enrolled
    Japan: 496
    Country: Number of subjects enrolled
    Korea, Republic of: 870
    Country: Number of subjects enrolled
    Mexico: 364
    Country: Number of subjects enrolled
    Netherlands: 479
    Country: Number of subjects enrolled
    Norway: 191
    Country: Number of subjects enrolled
    Peru: 173
    Country: Number of subjects enrolled
    Philippines: 92
    Country: Number of subjects enrolled
    Romania: 80
    Country: Number of subjects enrolled
    Saudi Arabia: 155
    Country: Number of subjects enrolled
    Slovakia: 244
    Country: Number of subjects enrolled
    Thailand: 231
    Country: Number of subjects enrolled
    Turkey: 225
    Country: Number of subjects enrolled
    Sweden: 224
    Country: Number of subjects enrolled
    Taiwan: 803
    Country: Number of subjects enrolled
    Ukraine: 792
    Country: Number of subjects enrolled
    United States: 2266
    Country: Number of subjects enrolled
    Vietnam: 254
    Country: Number of subjects enrolled
    South Africa: 299
    Worldwide total number of subjects
    19220
    EEA total number of subjects
    7050
    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)
    7934
    From 65 to 84 years
    11115
    85 years and over
    171

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    In total, 20108 patients were enrolled, 19220 patients were randomised to study drug and included in the analyses, from 1315 study sites in 42 countries. The first patient was enrolled on 10 February 2014. The last patient visit took place on 25 January 2019.

    Pre-assignment
    Screening details
    Enrolled patients randomised to study drug 95.8%; n =19271, of which 51 patients were randomised to study drug at a site prematurely closed by sponsor and excluded from the study results. Patients who were not randomised 4.2%; n=837. Patient did not meet inclusion/exclusion criteria n=454, Patient decision n=256, Death n=1, Other reason n=131.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ticagrelor 60 mg
    Arm description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Ticegrelor 90mg film-coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg twice daily

    Investigational medicinal product name
    Ticagrelor 60mg film-coated tablets
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    60 mg twice daily

    Arm title
    Ticagrelor placebo
    Arm description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.
    Arm type
    Placebo

    Investigational medicinal product name
    Ticagrelor 60 mg placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching 60mg ticagrelor placebo twice daily

    Investigational medicinal product name
    Ticagrelor 90 mg placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching 90mg ticagrelor placebo twice daily

    Number of subjects in period 1
    Ticagrelor 60 mg Ticagrelor placebo
    Started
    9619
    9601
    Completed
    9496
    9503
    Not completed
    123
    98
         Consent withdrawn by subject
    117
    94
         Lost to follow-up
    6
    4

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

    Reporting group title
    Ticagrelor placebo
    Reporting group description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

    Reporting group values
    Ticagrelor 60 mg Ticagrelor placebo Total
    Number of subjects
    9619 9601 19220
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    3975 3959 7934
        From 65-84 years
    5560 5555 11115
        85 years and over
    84 87 171
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    66.3 ± 7.8 66.3 ± 7.7 -
    Sex: Female, Male
    Units: Subjects
        Male
    6576 6613 13189
        Female
    3043 2988 6031
    Region of Enrollment
    Units: Subjects
        ARG
    195 199 394
        AUS
    94 94 188
        AUT
    42 45 87
        BEL
    109 108 217
        BGR
    435 443 878
        BRA
    412 399 811
        CAN
    364 365 729
        CHL
    152 148 300
        CHN
    456 454 910
        COL
    68 68 136
        CZE
    304 298 602
        DEU
    277 270 547
        DNK
    123 120 243
        ESP
    170 170 340
        FIN
    60 58 118
        FRA
    85 87 172
        GBR
    123 123 246
        HKG
    76 76 152
        HUN
    306 310 616
        IND
    147 145 292
        ISR
    60 57 117
        ITA
    67 63 130
        JPN
    246 250 496
        KOR
    433 437 870
        MEX
    182 182 364
        NLD
    242 237 479
        NOR
    95 96 191
        PER
    91 82 173
        PHL
    47 45 92
        POL
    815 821 1636
        ROU
    37 43 80
        RUS
    561 560 1121
        SAU
    79 76 155
        SVK
    122 122 244
        SWE
    110 114 224
        THA
    115 116 231
        TUR
    113 112 225
        TWN
    402 401 803
        UKR
    399 393 792
        USA
    1126 1140 2266
        VNM
    129 125 254
        ZAF
    150 149 299
    Race/Ethnicity, Customized
    Units: Subjects
        White
    6838 6858 13696
        Black or african american
    205 198 403
        Asian
    2211 2195 4406
        Native hawaiian or other pacific islander
    7 7 14
        American indian or alaska native
    161 152 313
        Other
    197 191 388

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

    Reporting group title
    Ticagrelor placebo
    Reporting group description
    Initially ticagrelor 90 mg or corresponding placebo was the selected dose, but reduced to ticagrelor 60 mg or corresponding placebo in Clinical Study Protocol Amendment No 1.

    Primary: Composite of Cardiovascular (CV) Death, MI or Stroke

    Close Top of page
    End point title
    Composite of Cardiovascular (CV) Death, MI or Stroke
    End point description
    Participants with Cardiovascular (CV) death, myocardial infarction (MI) or stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
    End point type
    Primary
    End point timeframe
    From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9619
    9601
    Units: Number of participants with event
    736
    818
    Statistical analysis title
    Prevention of composite of CV death, MI or stroke
    Statistical analysis description
    Time to first occurrence of any event from the composite of CV death, MI or stroke.
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19220
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0378 [1]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.81
         upper limit
    0.99
    Notes
    [1] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: CV death

    Close Top of page
    End point title
    CV death
    End point description
    Participants with Cardiovascular (CV) death. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and non-CV death date.
    End point type
    Secondary
    End point timeframe
    From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9619
    9601
    Units: Number of participants with event
    364
    357
    Statistical analysis title
    Prevention of CV death
    Statistical analysis description
    Time from randomisation to death of CV cause
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19220
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7883 [2]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.88
         upper limit
    1.18
    Notes
    [2] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: MI

    Close Top of page
    End point title
    MI
    End point description
    Participants with myocardial infarction. If no event, censoring occurs at the earliest of primary analysis censoring date (PACD), last endpoint assessment date and death date
    End point type
    Secondary
    End point timeframe
    From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9619
    9601
    Units: Number of participants with event
    274
    328
    Statistical analysis title
    Prevention of MI
    Statistical analysis description
    Time from randomisation to first occurrence of MI.
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19220
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0294 [3]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.71
         upper limit
    0.98
    Notes
    [3] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: Ischaemic stroke

    Close Top of page
    End point title
    Ischaemic stroke
    End point description
    Participants with ischaemic stroke. If no event, censoring occurs at the earliest of PACD, last endpoint assessment date and death date.
    End point type
    Secondary
    End point timeframe
    From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9619
    9601
    Units: Number of participants with event
    152
    191
    Statistical analysis title
    Prevention of ischaemic stroke
    Statistical analysis description
    Time from randomisation to first occurrence of ischaemic stroke
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19220
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0375 [4]
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.64
         upper limit
    0.99
    Notes
    [4] - The hypothesis will be tested at the 4.96% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: All-cause death

    Close Top of page
    End point title
    All-cause death
    End point description
    Participants with all-cause death. If no event, censoring occurs at the earliest of PACD and last endpoint assessment date. Includes deaths based on publically available vital status data in patients who have withdrawn consent.
    End point type
    Secondary
    End point timeframe
    From randomisation to primary analysis censoring date (PACD). Median time in study until PACD was 40 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9619
    9601
    Units: Number of participants with event
    579
    592
    Statistical analysis title
    Prevention of all-cause death
    Statistical analysis description
    Time from randomisation to death of any cause
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19220
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.6846
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    0.98
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.87
         upper limit
    1.1

    Other pre-specified: TIMI Major bleeding event (primary safety objective)

    Close Top of page
    End point title
    TIMI Major bleeding event (primary safety objective)
    End point description
    Participants with TIMI major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
    End point type
    Other pre-specified
    End point timeframe
    From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9562 [5]
    9531 [6]
    Units: Number of participants with event
    206
    100
    Notes
    [5] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    [6] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    Statistical analysis title
    TIMI major bleeding
    Statistical analysis description
    Time to first TIMI major bleeding event
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19093
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.32
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.82
         upper limit
    2.94

    Other pre-specified: TIMI major or minor bleeding event

    Close Top of page
    End point title
    TIMI major or minor bleeding event
    End point description
    Participants with TIMI major or minor bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
    End point type
    Other pre-specified
    End point timeframe
    From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9562 [7]
    9531 [8]
    Units: Number of participants with event
    285
    129
    Notes
    [7] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    [8] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    Statistical analysis title
    TIMI major or minor bleeding
    Statistical analysis description
    Time to first TIMI major or minor bleeding
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19093
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.02
         upper limit
    3.07

    Other pre-specified: PLATO major bleeding event

    Close Top of page
    End point title
    PLATO major bleeding event
    End point description
    Participants with PLATO major bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and 7 days following the date of last dose of study medication
    End point type
    Other pre-specified
    End point timeframe
    From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9562 [9]
    9531 [10]
    Units: Number of participants with event
    310
    145
    Notes
    [9] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    [10] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    Statistical analysis title
    PLATO major bleeding
    Statistical analysis description
    Time to first PLATO major bleeding
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19093
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    2.41
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.98
         upper limit
    2.93

    Other pre-specified: Permanent discontinuation of study medication due to any bleeding event

    Close Top of page
    End point title
    Permanent discontinuation of study medication due to any bleeding event
    End point description
    Participants with permanent discontinuation of study medication due to any bleeding event. If no event, censoring occurs at the earliest of last endpoint assessment date, death date and the date of last dose of study medication
    End point type
    Other pre-specified
    End point timeframe
    From randomisation to 7 days following the date of last dose of study medication. Maximum duration of exposure was 59 months.
    End point values
    Ticagrelor 60 mg Ticagrelor placebo
    Number of subjects analysed
    9562 [11]
    9531 [12]
    Units: Number of participants with event
    466
    125
    Notes
    [11] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    [12] - Safety analyses included subjects who received at least 1 dose of randomised ticagrelor or placebo
    Statistical analysis title
    Permanent discontinuation of IP due to bleeding
    Statistical analysis description
    Time to permanent discontinuation of study medication due to any bleeding event
    Comparison groups
    Ticagrelor 60 mg v Ticagrelor placebo
    Number of subjects included in analysis
    19093
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.0001
    Method
    Regression, Cox
    Parameter type
    Hazard ratio (HR)
    Point estimate
    4.04
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.32
         upper limit
    4.92

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From Randomisation until last dose of study drug + 7 days
    Adverse event reporting additional description
    Systematic assessment of suspected bleeding events, suspected endpoint events, serious adverse events, adverse events that leads to permanent discontinuation of study medication and non-serious AEs of interest (ie, dyspnoea, renal impairment, bradyarrhythmia, gout, and pneumonia),
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    Ticagrelor
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    Ticagrelor Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3049 / 9562 (31.89%)
    3210 / 9531 (33.68%)
         number of deaths (all causes)
    187
    223
         number of deaths resulting from adverse events
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Air embolism
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiopathy
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    8 / 9562 (0.08%)
    9 / 9531 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    5 / 9562 (0.05%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artery dissection
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atherosclerotic plaque rupture
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 9562 (0.01%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    6 / 9562 (0.06%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    5 / 9562 (0.05%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    36 / 9562 (0.38%)
    45 / 9531 (0.47%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    15 / 9562 (0.16%)
    23 / 9531 (0.24%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    4 / 9562 (0.04%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    9 / 9562 (0.09%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery disease
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery embolism
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    9 / 9562 (0.09%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labile blood pressure
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis ischaemic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic shock
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    7 / 9562 (0.07%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    31 / 9562 (0.32%)
    48 / 9531 (0.50%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 60
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    10 / 9562 (0.10%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    5 / 9562 (0.05%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral coldness
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    14 / 9562 (0.15%)
    18 / 9531 (0.19%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    3 / 9562 (0.03%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    3 / 9562 (0.03%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid vasculitis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Shock haemorrhagic
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subgaleal haematoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular compression
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular occlusion
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Acute promyelocytic leukaemia
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    14 / 9562 (0.15%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 9562 (0.05%)
    9 / 9531 (0.09%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder cancer
         subjects affected / exposed
    8 / 9562 (0.08%)
    9 / 9531 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer female
         subjects affected / exposed
    9 / 9562 (0.09%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 9562 (0.01%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carcinoid tumour
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellopontine angle tumour
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma recurrent
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervix carcinoma stage 0
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cholesteatoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chordoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    12 / 9562 (0.13%)
    16 / 9531 (0.17%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Colon neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous lymphoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer metastatic
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibroadenoma of breast
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrosarcoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrous histiocytoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric adenoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    7 / 9562 (0.07%)
    10 / 9531 (0.10%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 10
         deaths causally related to treatment / all
    1 / 1
    0 / 3
    Gastric neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal lymphoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal melanoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal stromal tumour
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic cancer
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hepatic cancer metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatobiliary neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    9 / 9562 (0.09%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Invasive breast carcinoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    3 / 9562 (0.03%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipofibroma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    3 / 9562 (0.03%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung cancer metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    14 / 9562 (0.15%)
    20 / 9531 (0.21%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 20
         deaths causally related to treatment / all
    0 / 8
    0 / 12
    Lymphoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    7 / 9562 (0.07%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to lung
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic malignant melanoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoclonal gammopathy
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscle neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasopharyngeal cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm prostate
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral neoplasm benign
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ovarian fibroma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian granulosa cell tumour
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    12 / 9562 (0.13%)
    12 / 9531 (0.13%)
         occurrences causally related to treatment / all
    1 / 13
    1 / 12
         deaths causally related to treatment / all
    0 / 8
    1 / 7
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic sarcoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penis carcinoma metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Phyllodes tumour
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleomorphic liposarcoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural neoplasm
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Prostate cancer
         subjects affected / exposed
    31 / 9562 (0.32%)
    36 / 9531 (0.38%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 36
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Prostate cancer stage 0
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    9 / 9562 (0.09%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer recurrent
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    3 / 9562 (0.03%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    5 / 9562 (0.05%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    3 / 9562 (0.03%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Small cell lung cancer recurrent
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine carcinoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue sarcoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Squamous cell carcinoma of lung
         subjects affected / exposed
    3 / 9562 (0.03%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the cervix
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thyroid cancer recurrent
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    4 / 9562 (0.04%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma stage I
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma stage II
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer stage I
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer stage II
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm papilla of Vater
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 9562 (0.00%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 9562 (0.00%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Administration site phlebitis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    4 / 9562 (0.04%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Capsular contracture associated with breast implant
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    4 / 9562 (0.04%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    5 / 9562 (0.05%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    6 / 9562 (0.06%)
    11 / 9531 (0.12%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    52 / 9562 (0.54%)
    60 / 9531 (0.63%)
         occurrences causally related to treatment / all
    0 / 52
    1 / 60
         deaths causally related to treatment / all
    0 / 52
    1 / 60
    Drowning
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Facial pain
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body reaction
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait inability
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal exfoliation
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Necrobiosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    54 / 9562 (0.56%)
    66 / 9531 (0.69%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 72
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 9562 (0.01%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker generated arrhythmia
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    8 / 9562 (0.08%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    6 / 9562 (0.06%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 8
         deaths causally related to treatment / all
    1 / 6
    0 / 8
    Sudden death
         subjects affected / exposed
    5 / 9562 (0.05%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    6 / 9562 (0.06%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline personality disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Confusional state
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 9562 (0.03%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium tremens
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    6 / 9562 (0.06%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Illness anxiety disorder
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropsychiatric symptoms
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired phimosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    26 / 9562 (0.27%)
    21 / 9531 (0.22%)
         occurrences causally related to treatment / all
    1 / 26
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix disorder
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial atrophy
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic fibrosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic haemorrhage
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    7 / 9562 (0.07%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    2 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine fibrosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    3 / 9562 (0.03%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident at home
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal gland injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic stenosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    8 / 9562 (0.08%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass thrombosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract traumatic
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    7 / 9562 (0.07%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft stenosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    5 / 9562 (0.05%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dislocation of sternum
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidural haemorrhage
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extraskeletal ossification
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to anastomose
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    5 / 9562 (0.05%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    8 / 9562 (0.08%)
    15 / 9531 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 9562 (0.02%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    8 / 9562 (0.08%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Heat stroke
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    8 / 9562 (0.08%)
    9 / 9531 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    12 / 9562 (0.13%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 9562 (0.01%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    4 / 9562 (0.04%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    12 / 9562 (0.13%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral plexus injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Median nerve injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    9 / 9562 (0.09%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root injury lumbar
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    3 / 9562 (0.03%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haemorrhage
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprocedural myocardial infarction
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural complication
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fever
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    4 / 9562 (0.04%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    11 / 9562 (0.12%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    6 / 11
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative respiratory failure
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation pneumonitis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    6 / 9562 (0.06%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    4 / 9562 (0.04%)
    10 / 9531 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scapula fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt malfunction
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skeletal injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 9562 (0.02%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomal hernia
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    23 / 9562 (0.24%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    12 / 23
    3 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    8 / 9562 (0.08%)
    5 / 9531 (0.05%)
         occurrences causally related to treatment / all
    3 / 8
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Tendon injury
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 9562 (0.02%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 9562 (0.03%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    7 / 9562 (0.07%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    4 / 7
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemorrhage
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Traumatic haemothorax
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    11 / 9562 (0.12%)
    7 / 9531 (0.07%)
         occurrences causally related to treatment / all
    4 / 11
    1 / 7
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Ulna fracture
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    6 / 9562 (0.06%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention postoperative
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound haemorrhage
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile output decreased
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood follicle stimulating hormone increased
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    5 / 9562 (0.05%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactic acid increased
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urine present
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    3 / 9562 (0.03%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram abnormal
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    2 / 9562 (0.02%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count decreased
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QRS complex prolonged
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B surface antigen positive
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    20 / 9562 (0.21%)
    22 / 9531 (0.23%)
         occurrences causally related to treatment / all
    3 / 20
    1 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Acute left ventricular failure
         subjects affected / exposed
    5 / 9562 (0.05%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    126 / 9562 (1.32%)
    197 / 9531 (2.07%)
         occurrences causally related to treatment / all
    6 / 133
    7 / 203
         deaths causally related to treatment / all
    0 / 14
    0 / 19
    Angina pectoris
         subjects affected / exposed
    200 / 9562 (2.09%)
    251 / 9531 (2.63%)
         occurrences causally related to treatment / all
    5 / 239
    7 / 267
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    354 / 9562 (3.70%)
    405 / 9531 (4.25%)
         occurrences causally related to treatment / all
    13 / 403
    16 / 449
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Aortic valve disease
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    8 / 9562 (0.08%)
    14 / 9531 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arteriosclerosis coronary artery
         subjects affected / exposed
    9 / 9562 (0.09%)
    8 / 9531 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Atrial fibrillation
         subjects affected / exposed
    82 / 9562 (0.86%)
    76 / 9531 (0.80%)
         occurrences causally related to treatment / all
    0 / 84
    3 / 80
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    12 / 9562 (0.13%)
    13 / 9531 (0.14%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    2 / 9562 (0.02%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    16 / 9562 (0.17%)
    18 / 9531 (0.19%)
         occurrences causally related to treatment / all
    3 / 16
    2 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    12 / 9562 (0.13%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    1 / 12
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bifascicular block
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    15 / 9562 (0.16%)
    6 / 9531 (0.06%)
         occurrences causally related to treatment / all
    2 / 15
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block right
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    7 / 9562 (0.07%)
    12 / 9531 (0.13%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 12
         deaths causally related to treatment / all
    1 / 6
    1 / 9
    Cardiac disorder
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    64 / 9562 (0.67%)
    87 / 9531 (0.91%)
         occurrences causally related to treatment / all
    2 / 84
    0 / 108
         deaths causally related to treatment / all
    0 / 11
    0 / 9
    Cardiac failure acute
         subjects affected / exposed
    20 / 9562 (0.21%)
    14 / 9531 (0.15%)
         occurrences causally related to treatment / all
    6 / 27
    0 / 15
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Cardiac failure chronic
         subjects affected / exposed
    18 / 9562 (0.19%)
    30 / 9531 (0.31%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 44
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Cardiac failure congestive
         subjects affected / exposed
    60 / 9562 (0.63%)
    47 / 9531 (0.49%)
         occurrences causally related to treatment / all
    0 / 71
    2 / 53
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Cardiac tamponade
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac valve disease
         subjects affected / exposed
    0 / 9562 (0.00%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventricular scarring
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    3 / 9562 (0.03%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Cardiogenic shock
         subjects affected / exposed
    6 / 9562 (0.06%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Cardiomyopathy
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    85 / 9562 (0.89%)
    90 / 9531 (0.94%)
         occurrences causally related to treatment / all
    3 / 89
    5 / 95
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coronary artery occlusion
         subjects affected / exposed
    2 / 9562 (0.02%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    14 / 9562 (0.15%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    3 / 9562 (0.03%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    7 / 9562 (0.07%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 9562 (0.02%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    41 / 9562 (0.43%)
    65 / 9531 (0.68%)
         occurrences causally related to treatment / all
    0 / 43
    1 / 66
         deaths causally related to treatment / all
    0 / 11
    0 / 16
    Myocardial ischaemia
         subjects affected / exposed
    36 / 9562 (0.38%)
    47 / 9531 (0.49%)
         occurrences causally related to treatment / all
    1 / 37
    0 / 50
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Myocarditis
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    4 / 9562 (0.04%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 9562 (0.02%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 9562 (0.03%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis constrictive
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 9562 (0.00%)
    3 / 9531 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary valve incompetence
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 9562 (0.01%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    1 / 9562 (0.01%)
    0 / 9531 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    7 / 9562 (0.07%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    5 / 9562 (0.05%)
    4 / 9531 (0.04%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 9562 (0.01%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 9562 (0.00%)
    1 / 9531 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    3 / 9562 (0.03%)
    2 / 9531 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    5 / 9562 (0.05%)
    9 / 9531 (0.09%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia