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    Clinical Trial Results:
    Cardiovascular outcomes study to evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with a recent acute coronary syndrome (ACS) event and type 2 diabetes mellitus (T2D)

    Summary
    EudraCT number
    		 2009-012269-71
    Trial protocol
    		 DE   ES   SE   DK   FR   IE   HU   CZ   GB   IT  
    Global end of trial date
    18 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2016
    First version publication date
    28 Oct 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    BC22140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01042769
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    global.trial_information@roche.com, F. Hoffmann-La Roche AG,, +41 61 687 83333, global.trial_information@roche.com
    Scientific contact
    +41 61 6878333,, Roche Trial Information Hotline,, +41 61 687 83333, global.trial_information@roche.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
    17 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To determine whether aleglitazar reduces cardiovascular mortality and morbidity (defined as non-fatal myocardial infarction (MI) and non-fatal stroke) in patients with a recent ACS event and T2D.
    Protection of trial subjects
    All participants signed an informed consent form before enrollment into the study.
    Background therapy
    		 Contemporary evidence-based medical care for ACS (e.g., antiplatelets, beta-blockers, ACE-inhibitors, and statins), and diabetes (e.g., diet, exercise, antihyperglycemic medications).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 May 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 631
    Country: Number of subjects enrolled
    India: 602
    Country: Number of subjects enrolled
    Korea, Republic of: 233
    Country: Number of subjects enrolled
    Thailand: 232
    Country: Number of subjects enrolled
    Malaysia: 120
    Country: Number of subjects enrolled
    Australia: 98
    Country: Number of subjects enrolled
    New Zealand: 61
    Country: Number of subjects enrolled
    Russian Federation: 42
    Country: Number of subjects enrolled
    Poland: 638
    Country: Number of subjects enrolled
    Spain: 448
    Country: Number of subjects enrolled
    Germany: 279
    Country: Number of subjects enrolled
    Hungary: 251
    Country: Number of subjects enrolled
    Italy: 157
    Country: Number of subjects enrolled
    United Kingdom: 134
    Country: Number of subjects enrolled
    Sweden: 132
    Country: Number of subjects enrolled
    Czech Republic: 124
    Country: Number of subjects enrolled
    Netherlands: 94
    Country: Number of subjects enrolled
    France: 92
    Country: Number of subjects enrolled
    Romania: 90
    Country: Number of subjects enrolled
    Ireland: 43
    Country: Number of subjects enrolled
    Denmark: 28
    Country: Number of subjects enrolled
    United States: 1094
    Country: Number of subjects enrolled
    Canada: 545
    Country: Number of subjects enrolled
    Mexico: 369
    Country: Number of subjects enrolled
    Brazil: 533
    Country: Number of subjects enrolled
    Argentina: 156
    Worldwide total number of subjects
    7226
    EEA total number of subjects
    2510
    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)
    4836
    From 65 to 84 years
    2354
    85 years and over
    36

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 An Eligibility Screening Form [ESF] documenting the investigator’s assessment of each screened patient with regard to the protocol’s inclusion and exclusion criteria was completed by the investigator.

    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, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Aleglitazar
    Arm description
    		 Aleglitazar 150 µg tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    Aleglitazar
    Investigational medicinal product code
    Ro 72-8804/F23
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily

    Arm title
    		 Placebo
    Arm description
    		 Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Matching placebo tablet
    Investigational medicinal product code
    (Ro 72-8804/F20)
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Once daily

    Number of subjects in period 1
    		Aleglitazar Placebo
    Started
    3616
    3610
    Completed
    3244
    3243
    Not completed
    372
    367
         Adverse event, serious fatal
    147
    139
         Consent withdrawn by subject
    120
    108
         Missing information
    -
    1
         Lost to follow-up
    105
    119

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Aleglitazar
    Reporting group description
    		 Aleglitazar 150 µg tablet

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Reporting group values
    		 Aleglitazar Placebo Total
    Number of subjects
    		 3616 3610 7226
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 2374 2462 4836
        From 65-84 years
    		 1220 1134 2354
        85 years and over
    		 21 14 35
        Not recorded
    		 1 0 1
    Gender categorical
    Units: Subjects
        Female
    		 974 991 1965
        Male
    		 2641 2619 5260
        Not recorded
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    Aleglitazar
    Reporting group description
    		 Aleglitazar 150 µg tablet

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Primary: Number of patients with first occurrence of any component of a composite of cardiovascular death, nonfatal myocardial infarction and non-fatal stroke as adjudicated by the Clinical Events Committee (CEC)

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    End point title
    		 Number of patients with first occurrence of any component of a composite of cardiovascular death, nonfatal myocardial infarction and non-fatal stroke as adjudicated by the Clinical Events Committee (CEC)
    End point description
    End point type
    Primary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3616
    3610
    Units: Patients
    344
    362
    Statistical analysis title
    		 Primary outcome measure
    Comparison groups
    Placebo v Aleglitazar
    Number of subjects included in analysis
    7226
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.566
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.11

    Secondary: Number of patients with other cardiovascular outcomes

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    End point title
    		 Number of patients with other cardiovascular outcomes
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3616
    3610
    Units: Patients
        Any cardiovscular death
    112
    98
        Any non-fatal myocardial infarction
    212
    239
        Any non-fatal stroke
    49
    52
        All-cause mortality
    148
    139
        Hosp. for unstable angina
    118
    156
        Hosp. for heart failure
    122
    100
    No statistical analyses for this end point

    Secondary: Mean absolute change from baseline to end of treatment in glycated hemoglobin (HbA1c)

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    End point title
    		 Mean absolute change from baseline to end of treatment in glycated hemoglobin (HbA1c)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3362
    3371
    Units: Value
        arithmetic mean (standard deviation)
    -0.7 ± 1.5
    -0.1 ± 1.5
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in low-density lipoprotein cholesterol (LDL-C)

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    End point title
    		 Mean percentage change from baseline to end of treatment in low-density lipoprotein cholesterol (LDL-C)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3243
    3212
    Units: Value
        arithmetic mean (standard deviation)
    23.1 ± 50.8
    16.6 ± 49
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in high-density lipoprotein cholesterol (HDL-C)

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    End point title
    		 Mean percentage change from baseline to end of treatment in high-density lipoprotein cholesterol (HDL-C)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3301
    3289
    Units: Value
        arithmetic mean (standard deviation)
    24.8 ± 27.4
    10.3 ± 23.1
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in triglycerides (TG)

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    End point title
    		 Mean percentage change from baseline to end of treatment in triglycerides (TG)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3302
    3290
    Units: Value
        arithmetic mean (standard deviation)
    -13.1 ± 46.5
    22 ± 67.8
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in apolipoprotein A-I (ApoA1)

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    End point title
    		 Mean percentage change from baseline to end of treatment in apolipoprotein A-I (ApoA1)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3296
    3279
    Units: Value
        arithmetic mean (standard deviation)
    10.3 ± 20.3
    7.9 ± 18.3
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in apolipoprotein B (ApoB)

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    End point title
    		 Mean percentage change from baseline to end of treatment in apolipoprotein B (ApoB)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3296
    3279
    Units: Value
        arithmetic mean (standard deviation)
    4.8 ± 33.2
    10.2 ± 32.8
    No statistical analyses for this end point

    Secondary: Mean absolute change from baseline to end of treatment in fibrinogen-C

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    End point title
    		 Mean absolute change from baseline to end of treatment in fibrinogen-C
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3151
    3145
    Units: Value
        arithmetic mean (standard deviation)
    -110.1 ± 139.5
    -68.2 ± 145.2
    No statistical analyses for this end point

    Secondary: Median percent change from baseline to end of treatment (Q1 – Q3) in high-sensitivity C-reactive protein (hs-CRP-C)

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    End point title
    		 Median percent change from baseline to end of treatment (Q1 – Q3) in high-sensitivity C-reactive protein (hs-CRP-C)
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3287
    3291
    Units: Value
        median (inter-quartile range (Q1-Q3))
    -31.5 (-70.7 to 35)
    -23 (-64.9 to 43.7)
    No statistical analyses for this end point

    Secondary: Mean percentage change from baseline to end of treatment in adiponectin

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    End point title
    		 Mean percentage change from baseline to end of treatment in adiponectin
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3259
    3235
    Units: Value
        arithmetic mean (standard deviation)
    212 ± 214.2
    16.2 ± 57.4
    No statistical analyses for this end point

    Secondary: Number of patients with at least one adverse event

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    End point title
    		 Number of patients with at least one adverse event
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3587
    3587
    Units: Patients
    2719
    2515
    No statistical analyses for this end point

    Secondary: Total number of adverse events

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    End point title
    		 Total number of adverse events
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3587
    3587
    Units: AEs
    11853
    10252
    No statistical analyses for this end point

    Secondary: Deaths

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    End point title
    		 Deaths
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3587
    3587
    Units: Deaths
    148
    139
    No statistical analyses for this end point

    Secondary: Patients with at least one serious adverse event

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    End point title
    		 Patients with at least one serious adverse event
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3587
    3587
    Units: Patients
    901
    833
    No statistical analyses for this end point

    Secondary: Patients with adverse events leading to withdrawal from treatment

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    End point title
    		 Patients with adverse events leading to withdrawal from treatment
    End point description
    End point type
    Secondary
    End point timeframe
    3 years
    End point values
    		 Aleglitazar Placebo
    Number of subjects analysed
    3587
    3587
    Units: Patients
    286
    165
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 89 weeks.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Aleglitazar
    Reporting group description
    		 Aleglitazar 150 µg tablet

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo

    Serious adverse events
    		 Aleglitazar Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1015 / 3587 (28.30%)
    947 / 3587 (26.40%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PROSTATE CANCER
         subjects affected / exposed
    11 / 3587 (0.31%)
    13 / 3587 (0.36%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLON CANCER
         subjects affected / exposed
    5 / 3587 (0.14%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOCARCINOMA OF COLON
         subjects affected / exposed
    4 / 3587 (0.11%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    BLADDER CANCER
         subjects affected / exposed
    4 / 3587 (0.11%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    2 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST CANCER
         subjects affected / exposed
    2 / 3587 (0.06%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG ADENOCARCINOMA
         subjects affected / exposed
    3 / 3587 (0.08%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG NEOPLASM MALIGNANT
         subjects affected / exposed
    3 / 3587 (0.08%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BASAL CELL CARCINOMA
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         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
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATIC CARCINOMA METASTATIC
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    ADENOCARCINOMA GASTRIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC CANCER
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    METASTASES TO LIVER
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL CANCER
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CANCER
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CELL CARCINOMA
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SQUAMOUS CELL CARCINOMA OF LUNG
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    B-CELL LYMPHOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BILIARY CANCER METASTATIC
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    BREAST CANCER METASTATIC
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NON-SMALL CELL LUNG CANCER
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PANCREATIC CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    UTERINE LEIOMYOMA
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE LEUKAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE MYELOID LEUKAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOCARCINOMA PANCREAS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ADENOID CYSTIC CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 EPIDIDYMIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BENIGN RENAL NEOPLASM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLADDER CANCER RECURRENT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLADDER NEOPLASM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BOWEN'S DISEASE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST NEOPLASM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BRONCHIAL CARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CARCINOID TUMOUR OF THE DUODENUM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CERVIX CARCINOMA STAGE II
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC LYMPHOCYTIC LEUKAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLEAR CELL RENAL CELL CARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC MYELOMONOCYTIC LEUKAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLON CANCER METASTATIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EAR NEOPLASM MALIGNANT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE)
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    GASTROINTESTINAL CARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HEPATIC CANCER METASTATIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL TRACT ADENOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HUERTHLE CELL CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL ADENOCARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARYNGEAL SQUAMOUS CELL CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INVASIVE LOBULAR BREAST CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LENTIGO MALIGNA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIPOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG ADENOCARCINOMA METASTATIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG CANCER METASTATIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT ASCITES
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT MELANOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT PLEURAL EFFUSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT NEOPLASM OF CONJUNCTIVA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MANTLE CELL LYMPHOMA STAGE IV
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDIASTINUM NEOPLASM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    MENINGIOMA BENIGN
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO ADRENALS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTASES TO LYMPH NODES
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    METASTASES TO RETROPERITONEUM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTATIC BRONCHIAL CARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    METASTATIC MALIGNANT MELANOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYELODYSPLASTIC SYNDROME
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METASTATIC RENAL CELL CARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NON-HODGKIN'S LYMPHOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 STAGE I
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NON-SMALL CELL LUNG CANCER STAGE IIIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL ADENOCARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    OESOPHAGEAL CARCINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATE CANCER METASTATIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL ADENOCARCINOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL NEOPLASM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SALIVARY GLAND CANCER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL CELL LUNG CANCER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 TONGUE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-CELL LYMPHOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    THYROID ADENOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETHRAL CANCER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    10 / 3587 (0.28%)
    12 / 3587 (0.33%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSIVE CRISIS
         subjects affected / exposed
    8 / 3587 (0.22%)
    10 / 3587 (0.28%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    9 / 3587 (0.25%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ISCHAEMIA
         subjects affected / exposed
    4 / 3587 (0.11%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    INTERMITTENT CLAUDICATION
         subjects affected / exposed
    3 / 3587 (0.08%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
         subjects affected / exposed
    5 / 3587 (0.14%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC ANEURYSM
         subjects affected / exposed
    5 / 3587 (0.14%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACCELERATED HYPERTENSION
         subjects affected / exposed
    2 / 3587 (0.06%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTREMITY NECROSIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOSCLEROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    DIABETIC VASCULAR DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATOMA
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOVOLAEMIC SHOCK
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PERIPHERAL VASCULAR DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSIVE EMERGENCY
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILIAC ARTERY OCCLUSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT HYPERTENSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOPHLEBITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIAL INSUFFICIENCY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIAL SPASM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CIRCULATORY COLLAPSE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DIABETIC MICROANGIOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMORAL ARTERY ANEURYSM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMORAL ARTERY EMBOLISM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLUSHING
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ISCHAEMIC LIMB PAIN
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JUGULAR VEIN THROMBOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LERICHE SYNDROME
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECROSIS ISCHAEMIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ARTERY ANEURYSM
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ARTERY THROMBOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SHOCK HAEMORRHAGIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VARICOSE VEIN
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR OCCLUSION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    KNEE ARTHROPLASTY
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC VALVE REPLACEMENT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATARACT OPERATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC PACEMAKER REPLACEMENT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT AMPUTATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEOSTOMY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPLANTABLE DEFIBRILLATOR INSERTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPLANTABLE DEFIBRILLATOR REMOVAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEG AMPUTATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATECTOMY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCAR EXCISION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THERAPY CHANGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOE AMPUTATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSURETHRAL PROSTATECTOMY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    NON-CARDIAC CHEST PAIN
         subjects affected / exposed
    93 / 3587 (2.59%)
    73 / 3587 (2.04%)
         occurrences causally related to treatment / all
    2 / 118
    4 / 81
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEATH
         subjects affected / exposed
    9 / 3587 (0.25%)
    14 / 3587 (0.39%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 14
         deaths causally related to treatment / all
    0 / 9
    1 / 14
    SUDDEN DEATH
         subjects affected / exposed
    6 / 3587 (0.17%)
    10 / 3587 (0.28%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 10
         deaths causally related to treatment / all
    1 / 6
    0 / 10
    SUDDEN CARDIAC DEATH
         subjects affected / exposed
    9 / 3587 (0.25%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 9
    0 / 3
    OEDEMA PERIPHERAL
         subjects affected / exposed
    6 / 3587 (0.17%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    2 / 6
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST DISCOMFORT
         subjects affected / exposed
    5 / 3587 (0.14%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYREXIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST PAIN
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FATIGUE
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPAIRED HEALING
         subjects affected / exposed
    4 / 3587 (0.11%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHENIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC DEATH
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    LOCAL SWELLING
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALAISE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHILLS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYST
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE BREAKAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE DISLOCATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG INTOLERANCE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROCUTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    GAIT DISTURBANCE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL HEALTH DETERIORATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERALISED OEDEMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA OBSTRUCTIVE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPLANT SITE HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLAMMATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL DEVICE COMPLICATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDICAL DEVICE PAIN
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTI-ORGAN FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECROBIOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SURGICAL FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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 STING
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONTRAST MEDIA ALLERGY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOD ALLERGY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERSENSITIVITY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSPLANT REJECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    PHYSICAL ASSAULT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    BENIGN PROSTATIC HYPERPLASIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERECTILE DYSFUNCTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVARIAN CYST
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACQUIRED HYDROCELE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST DYSPLASIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST HAEMATOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPIDIDYMITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENITAL TRACT INFLAMMATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENORRHAGIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROSTATIC OBSTRUCTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VAGINAL HAEMORRHAGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VULVAL ULCERATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    DYSPNOEA
         subjects affected / exposed
    22 / 3587 (0.61%)
    14 / 3587 (0.39%)
         occurrences causally related to treatment / all
    2 / 22
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE
         subjects affected / exposed
    17 / 3587 (0.47%)
    15 / 3587 (0.42%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PULMONARY OEDEMA
         subjects affected / exposed
    9 / 3587 (0.25%)
    12 / 3587 (0.33%)
         occurrences causally related to treatment / all
    1 / 9
    2 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURAL EFFUSION
         subjects affected / exposed
    8 / 3587 (0.22%)
    9 / 3587 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY EMBOLISM
         subjects affected / exposed
    10 / 3587 (0.28%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    RESPIRATORY FAILURE
         subjects affected / exposed
    7 / 3587 (0.20%)
    7 / 3587 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    ACUTE PULMONARY OEDEMA
         subjects affected / exposed
    5 / 3587 (0.14%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    PNEUMOTHORAX
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPNOEA EXERTIONAL
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE RESPIRATORY FAILURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ASTHMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COUGH
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURISY
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA ASPIRATION
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PNEUMONITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY HYPERTENSION
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SLEEP APNOEA SYNDROME
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS CHRONIC
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPISTAXIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOXIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PLEURITIC PAIN
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY FIBROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    RESPIRATORY DISTRESS
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ALLERGIC BRONCHITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC RESPIRATORY FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHONIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOPTYSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOTHORAX
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HICCUPS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROPNEUMOTHORAX
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERSTITIAL LUNG DISEASE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASAL POLYPS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORTHOPNOEA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOMEDIASTINUM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY THROMBOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY ARREST
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    4 / 3587 (0.11%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALCOHOL WITHDRAWAL SYNDROME
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DELIRIUM
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDE ATTEMPT
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALCOHOL ABUSE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREATHING-RELATED SLEEP DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMPLETED SUICIDE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    DELIRIUM TREMENS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG DEPENDENCE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HOMICIDAL IDEATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENTAL STATUS CHANGES
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANIC ATTACK
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSYCHOTIC DISORDER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOMATISATION DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STRESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUICIDAL IDEATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS ACUTE
         subjects affected / exposed
    9 / 3587 (0.25%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTITIS
         subjects affected / exposed
    6 / 3587 (0.17%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    6 / 3587 (0.17%)
    7 / 3587 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BILE DUCT STONE
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLANGITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BILIARY COLIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BILE DUCT OBSTRUCTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLANGITIS ACUTE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTITIS CHRONIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CIRRHOSIS ALCOHOLIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMOBILIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC CIRRHOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATITIS ACUTE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCHOLECYSTIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JAUNDICE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    10 / 3587 (0.28%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    7 / 10
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    4 / 3587 (0.11%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EJECTION FRACTION DECREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TROPONIN INCREASED
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSAMINASES INCREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT INCREASED
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TROPONIN I INCREASED
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD BILIRUBIN INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD POTASSIUM DECREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD PRESSURE DECREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BODY TEMPERATURE INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD URINE PRESENT
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ENZYMES INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROCARDIOGRAM T WAVE INVERSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXERCISE TEST ABNORMAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GAMMA-GLUTAMYLTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENERAL PHYSICAL CONDITION ABNORMAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GLOMERULAR FILTRATION RATE DECREASED
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATOCRIT DECREASED
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    N-TERMINAL PROHORMONE BRAIN NATRIURETIC PEPTIDE INCREASED
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    FEMUR FRACTURE
         subjects affected / exposed
    7 / 3587 (0.20%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    7 / 3587 (0.20%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    3 / 3587 (0.08%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    4 / 3587 (0.11%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    5 / 3587 (0.14%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT FRACTURE
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACERATION
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR PSEUDOANEURYSM
         subjects affected / exposed
    0 / 3587 (0.00%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONCUSSION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY RESTENOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENISCUS INJURY
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMATOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL COMPRESSION FRACTURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THORACIC VERTEBRAL FRACTURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXICITY TO VARIOUS AGENTS
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST INJURY
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CRANIOCEREBRAL INJURY
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMMINUTED FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FACIAL BONES FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT INJURY
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIMB INJURY
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER LIMB FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PATELLA FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         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
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    RADIUS FRACTURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    TENDON RUPTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THERMAL BURN
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACCIDENT
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACCIDENTAL OVERDOSE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACETABULUM FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ALCOHOL POISONING
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BONE FISSURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FIBULA FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL INJURY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAND FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPACTED FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT DISLOCATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIGAMENT SPRAIN
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIMB TRAUMATIC AMPUTATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUMBAR VERTEBRAL FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MECHANICAL VENTILATION COMPLICATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE INJURIES
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVERDOSE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPROSTHETIC FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL SWELLING
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE RESPIRATORY FAILURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTPERICARDIOTOMY SYNDROME
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY CONTUSION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY FUME INHALATION DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STERNAL FRACTURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VACCINATION COMPLICATION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR GRAFT OCCLUSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         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 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VITH NERVE INJURY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (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
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND SECRETION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    ATRIAL SEPTAL DEFECT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDROCELE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTROPHIC CARDIOMYOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PHIMOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYLORIC STENOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYRINGOMYELIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    ANGINA PECTORIS
         subjects affected / exposed
    86 / 3587 (2.40%)
    87 / 3587 (2.43%)
         occurrences causally related to treatment / all
    5 / 96
    1 / 100
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE
         subjects affected / exposed
    109 / 3587 (3.04%)
    62 / 3587 (1.73%)
         occurrences causally related to treatment / all
    21 / 147
    12 / 93
         deaths causally related to treatment / all
    1 / 11
    0 / 8
    CARDIAC FAILURE CONGESTIVE
         subjects affected / exposed
    63 / 3587 (1.76%)
    64 / 3587 (1.78%)
         occurrences causally related to treatment / all
    14 / 82
    12 / 88
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    ATRIAL FIBRILLATION
         subjects affected / exposed
    29 / 3587 (0.81%)
    20 / 3587 (0.56%)
         occurrences causally related to treatment / all
    1 / 40
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ARREST
         subjects affected / exposed
    13 / 3587 (0.36%)
    13 / 3587 (0.36%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 13
         deaths causally related to treatment / all
    0 / 11
    1 / 10
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    11 / 3587 (0.31%)
    12 / 3587 (0.33%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    CARDIAC FAILURE ACUTE
         subjects affected / exposed
    11 / 3587 (0.31%)
    11 / 3587 (0.31%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ARRHYTHMIA
         subjects affected / exposed
    8 / 3587 (0.22%)
    9 / 3587 (0.25%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    VENTRICULAR TACHYCARDIA
         subjects affected / exposed
    6 / 3587 (0.17%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    MYOCARDIAL ISCHAEMIA
         subjects affected / exposed
    7 / 3587 (0.20%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ACUTE LEFT VENTRICULAR FAILURE
         subjects affected / exposed
    5 / 3587 (0.14%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    5 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOGENIC SHOCK
         subjects affected / exposed
    7 / 3587 (0.20%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 2
         deaths causally related to treatment / all
    5 / 5
    1 / 1
    LEFT VENTRICULAR FAILURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    7 / 3587 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    AORTIC VALVE STENOSIS
         subjects affected / exposed
    5 / 3587 (0.14%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL FLUTTER
         subjects affected / exposed
    3 / 3587 (0.08%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEFT VENTRICULAR DYSFUNCTION
         subjects affected / exposed
    2 / 3587 (0.06%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR FIBRILLATION
         subjects affected / exposed
    3 / 3587 (0.08%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    BRADYCARDIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIO-RESPIRATORY ARREST
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    ISCHAEMIC CARDIOMYOPATHY
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SICK SINUS SYNDROME
         subjects affected / exposed
    1 / 3587 (0.03%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK COMPLETE
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CARDIAC DISCOMFORT
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC FAILURE CHRONIC
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PALPITATIONS
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY STENOSIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERICARDITIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERICARDIAL EFFUSION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPRAVENTRICULAR TACHYCARDIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TACHYCARDIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIAL TACHYCARDIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATRIOVENTRICULAR BLOCK SECOND DEGREE
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC ASTHMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTRASYSTOLES
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MITRAL VALVE INCOMPETENCE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIGHT VENTRICULAR FAILURE
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOSPASM CORONARY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC AMYLOIDOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CARDIAC TAMPONADE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOMYOPATHY ACUTE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIOPULMONARY FAILURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CARDIOVASCULAR DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CARDIOVASCULAR INSUFFICIENCY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC LEFT VENTRICULAR FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONOTROPIC INCOMPETENCE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY THROMBOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRESSLER'S SYNDROME
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTRACARDIAC THROMBUS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOW CARDIAC OUTPUT SYNDROME
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PRINZMETAL ANGINA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESTRICTIVE CARDIOMYOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS ARRHYTHMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SINUS TACHYCARDIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STRESS CARDIOMYOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR ARRHYTHMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENTRICULAR FAILURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    SYNCOPE
         subjects affected / exposed
    22 / 3587 (0.61%)
    23 / 3587 (0.64%)
         occurrences causally related to treatment / all
    0 / 23
    1 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    10 / 3587 (0.28%)
    9 / 3587 (0.25%)
         occurrences causally related to treatment / all
    2 / 10
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    4 / 3587 (0.11%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    2 / 3587 (0.06%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEADACHE
         subjects affected / exposed
    2 / 3587 (0.06%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC NEUROPATHY
         subjects affected / exposed
    4 / 3587 (0.11%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VERTEBROBASILAR INSUFFICIENCY
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARPAL TUNNEL SYNDROME
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONVULSION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSIVE ENCEPHALOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARAESTHESIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIITH NERVE PARALYSIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAROTID ARTERIOSCLEROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEMENTIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEMIPARESIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MIGRAINE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCIATICA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBARACHNOID HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    ALCOHOLIC SEIZURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATAXIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAROTID ARTERY ANEURYSM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAROTID ARTERY DISEASE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR INSUFFICIENCY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CERVICAL RADICULOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CERVICOBRACHIAL SYNDROME
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COGNITIVE DISORDER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEMIPLEGIC MIGRAINE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAND MAL CONVULSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIC COMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIC SEIZURE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIC UNCONSCIOUSNESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIC ENCEPHALOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOSS OF CONSCIOUSNESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUMBAR RADICULOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEMORY IMPAIRMENT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENINGITIS NONINFECTIVE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METABOLIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MONOPARESIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NERVE COMPRESSION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEURALGIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NORMAL PRESSURE HYDROCEPHALUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POLYNEUROPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPEECH DISORDER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STATUS EPILEPTICUS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VITH NERVE PARALYSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOCAL CORD PARALYSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    ANAEMIA
         subjects affected / exposed
    21 / 3587 (0.59%)
    18 / 3587 (0.50%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IRON DEFICIENCY ANAEMIA
         subjects affected / exposed
    5 / 3587 (0.14%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MICROCYTIC ANAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COAGULOPATHY
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FEBRILE NEUTROPENIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERNICIOUS ANAEMIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGIC ANAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NORMOCHROMIC NORMOCYTIC ANAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCYTOPENIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPLENIC INFARCTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOCYTOPENIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    VERTIGO
         subjects affected / exposed
    5 / 3587 (0.14%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VERTIGO POSITIONAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MIXED DEAFNESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VESTIBULAR DISORDER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    CATARACT
         subjects affected / exposed
    9 / 3587 (0.25%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETINAL ARTERY OCCLUSION
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VITREOUS HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AMAUROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONJUNCTIVAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC RETINOPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GLAUCOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LENTICULAR OPACITIES
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VISUAL ACUITY REDUCED
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VISUAL IMPAIRMENT
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    UPPER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    22 / 3587 (0.61%)
    13 / 3587 (0.36%)
         occurrences causally related to treatment / all
    3 / 23
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ULCER HAEMORRHAGE
         subjects affected / exposed
    7 / 3587 (0.20%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    10 / 3587 (0.28%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN
         subjects affected / exposed
    6 / 3587 (0.17%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DUODENAL ULCER HAEMORRHAGE
         subjects affected / exposed
    6 / 3587 (0.17%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    4 / 3587 (0.11%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS ACUTE
         subjects affected / exposed
    3 / 3587 (0.08%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    5 / 3587 (0.14%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPEPSIA
         subjects affected / exposed
    4 / 3587 (0.11%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL HAEMORRHAGE
         subjects affected / exposed
    2 / 3587 (0.06%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINE POLYP
         subjects affected / exposed
    5 / 3587 (0.14%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ULCER
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHOIDS
         subjects affected / exposed
    4 / 3587 (0.11%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MELAENA
         subjects affected / exposed
    4 / 3587 (0.11%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RECTAL HAEMORRHAGE
         subjects affected / exposed
    4 / 3587 (0.11%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VOMITING
         subjects affected / exposed
    0 / 3587 (0.00%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CONSTIPATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULUM
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSPHAGIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NAUSEA
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRITIS EROSIVE
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIATUS HERNIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL HAEMORRHAGE
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS INTESTINAL HAEMORRHAGIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULUM INTESTINAL HAEMORRHAGIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTERITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOLITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL ANGIODYSPLASIA HAEMORRHAGIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IMPAIRED GASTRIC EMPTYING
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL OBSTRUCTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL PERFORATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PEPTIC ULCER HAEMORRHAGE
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL ADHESIONS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL DISCOMFORT
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL PAIN LOWER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL WALL HAEMATOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHANGE OF BOWEL HABIT
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS ISCHAEMIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLITIS ULCERATIVE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULAR PERFORATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULUM INTESTINAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DUODENAL STENOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DUODENITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPIGASTRIC DISCOMFORT
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOD POISONING
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRIC ANTRAL VASCULAR ECTASIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRODUODENAL ULCER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTRODUODENITIS HAEMORRHAGIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL NECROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    GASTROINTESTINAL ULCER HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GINGIVAL BLEEDING
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATEMESIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGIC EROSIVE GASTRITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INGUINAL HERNIA STRANGULATED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL ISCHAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LARGE INTESTINAL ULCER HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    LARGE INTESTINE PERFORATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATITIS NECROTISING
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PEPTIC ULCER
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONEAL HAEMORRHAGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOPERITONEUM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCTALGIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RETROPERITONEAL HAEMATOMA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SIGMOIDITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL HAEMORRHAGE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SMALL INTESTINAL ULCER HAEMORRHAGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBILEUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UMBILICAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    SKIN ULCER
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC FOOT
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    DECUBITUS ULCER
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSORIASIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DERMATITIS ALLERGIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECCHYMOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PEMPHIGUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH GENERALISED
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN FISSURES
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    RENAL FAILURE ACUTE
         subjects affected / exposed
    33 / 3587 (0.92%)
    22 / 3587 (0.61%)
         occurrences causally related to treatment / all
    12 / 35
    4 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    RENAL FAILURE
         subjects affected / exposed
    14 / 3587 (0.39%)
    12 / 3587 (0.33%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    RENAL IMPAIRMENT
         subjects affected / exposed
    6 / 3587 (0.17%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    5 / 3587 (0.14%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROLITHIASIS
         subjects affected / exposed
    6 / 3587 (0.17%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE CHRONIC
         subjects affected / exposed
    5 / 3587 (0.14%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY RETENTION
         subjects affected / exposed
    5 / 3587 (0.14%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL COLIC
         subjects affected / exposed
    3 / 3587 (0.08%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CALCULUS URETERIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CALCULUS URINARY
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYDRONEPHROSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRERENAL FAILURE
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL ARTERY STENOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETHRAL STENOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AZOTAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    BLADDER TAMPONADE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYSTITIS HAEMORRHAGIC
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC NEPHROPATHY
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHRITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CYST
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINOMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    HYPERTHYROIDISM
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ADRENOCORTICAL INSUFFICIENCY ACUTE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    No Coding available
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    OSTEOARTHRITIS
         subjects affected / exposed
    14 / 3587 (0.39%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    6 / 3587 (0.17%)
    9 / 3587 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACK PAIN
         subjects affected / exposed
    2 / 3587 (0.06%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC PROTRUSION
         subjects affected / exposed
    7 / 3587 (0.20%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    2 / 3587 (0.06%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYALGIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRALGIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHABDOMYOLYSIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUMBAR SPINAL STENOSIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL COLUMN STENOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TENDONITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS REACTIVE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXOSTOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC DEGENERATION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERVERTEBRAL DISC DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE HAEMORRHAGE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE SPASMS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOPATHY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOCHONDROSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PALINDROMIC RHEUMATISM
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROTATOR CUFF SYNDROME
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCLERODERMA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL DISORDER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL PAIN
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPONDYLITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYSTEMIC LUPUS ERYTHEMATOSUS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    43 / 3587 (1.20%)
    40 / 3587 (1.12%)
         occurrences causally related to treatment / all
    0 / 47
    0 / 45
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    CELLULITIS
         subjects affected / exposed
    24 / 3587 (0.67%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 27
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    12 / 3587 (0.33%)
    20 / 3587 (0.56%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    5 / 3587 (0.14%)
    10 / 3587 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    SEPTIC SHOCK
         subjects affected / exposed
    4 / 3587 (0.11%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    BRONCHITIS
         subjects affected / exposed
    4 / 3587 (0.11%)
    7 / 3587 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOCALISED INFECTION
         subjects affected / exposed
    4 / 3587 (0.11%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GANGRENE
         subjects affected / exposed
    3 / 3587 (0.08%)
    6 / 3587 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    7 / 3587 (0.20%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    5 / 3587 (0.14%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPNEUMONIA
         subjects affected / exposed
    5 / 3587 (0.14%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    5 / 3587 (0.14%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOMYELITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    4 / 3587 (0.11%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    4 / 3587 (0.11%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ERYSIPELAS
         subjects affected / exposed
    0 / 3587 (0.00%)
    5 / 3587 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    3 / 3587 (0.08%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DENGUE FEVER
         subjects affected / exposed
    4 / 3587 (0.11%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS ACUTE
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS BACTERIAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDIASTINITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORCHITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS LIMB
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS NECK
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACUTE TONSILLITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL ABSCESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    IMPLANT SITE INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED SKIN ULCER
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
         subjects affected / exposed
    0 / 3587 (0.00%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLUENZA
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIRECTAL ABSCESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PHARYNGITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRACHEOBRONCHITIS
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABDOMINAL WALL INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACQUIRED IMMUNODEFICIENCY SYNDROME
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACTINOMYCOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ATYPICAL PNEUMONIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL SEPSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BONE TUBERCULOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BREAST ABSCESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS BACTERIAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BURSITIS INFECTIVE
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CANDIDA PNEUMONIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CANDIDA SEPSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS OF MALE EXTERNAL GENITAL ORGAN
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS STREPTOCOCCAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHEST WALL ABSCESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYSTITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTITIS INFECTIVE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC FOOT INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EAR TUBERCULOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOMETRITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOCARDITIS BACTERIAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOPHTHALMITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA BACTERAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS ROTAVIRUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENITOURINARY TRACT INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATOMA INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES ZOSTER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISION SITE CELLULITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HISTOPLASMOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTESTINAL GANGRENE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KLEBSIELLA SEPSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER ABSCESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUDWIG ANGINA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MASTOIDITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NASAL ABSCESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECROTISING FASCIITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    NEUROCYSTICERCOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OTITIS MEDIA CHRONIC
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARONYCHIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIODONTITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONITIS BACTERIAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PERITONSILLAR ABSCESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PILONIDAL CYST
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA KLEBSIELLA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL CELLULITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL PNEUMONIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSEUDOMEMBRANOUS COLITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY SEPSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    PULMONARY TUBERCULOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYONEPHROSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SALPINGITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SCROTAL ABSCESS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOFT TISSUE INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL BACTERAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STERNITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STREPTOCOCCAL ABSCESS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TYPHOID FEVER
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETERITIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION PSEUDOMONAL
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VARICELLA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL SINUSITIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION STAPHYLOCOCCAL
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    39 / 3587 (1.09%)
    17 / 3587 (0.47%)
         occurrences causally related to treatment / all
    20 / 42
    6 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIA
         subjects affected / exposed
    8 / 3587 (0.22%)
    10 / 3587 (0.28%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    7 / 3587 (0.20%)
    8 / 3587 (0.22%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETES MELLITUS INADEQUATE CONTROL
         subjects affected / exposed
    3 / 3587 (0.08%)
    9 / 3587 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOKALAEMIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    4 / 3587 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETES MELLITUS
         subjects affected / exposed
    1 / 3587 (0.03%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERKALAEMIA
         subjects affected / exposed
    3 / 3587 (0.08%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOMAGNESAEMIA
         subjects affected / exposed
    2 / 3587 (0.06%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC KETOACIDOSIS
         subjects affected / exposed
    0 / 3587 (0.00%)
    3 / 3587 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    2 / 3587 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLUID OVERLOAD
         subjects affected / exposed
    2 / 3587 (0.06%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DECREASED APPETITE
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLUID RETENTION
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERPHOSPHATAEMIA
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOCALCAEMIA
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KETOACIDOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METABOLIC ACIDOSIS
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TYPE 2 DIABETES MELLITUS
         subjects affected / exposed
    0 / 3587 (0.00%)
    1 / 3587 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OBESITY
         subjects affected / exposed
    1 / 3587 (0.03%)
    0 / 3587 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Aleglitazar Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1514 / 3587 (42.21%)
    1119 / 3587 (31.20%)
    Investigations
    WEIGHT INCREASED
         subjects affected / exposed
    395 / 3587 (11.01%)
    171 / 3587 (4.77%)
         occurrences all number
    417
    180
    BLOOD CREATININE INCREASED
         subjects affected / exposed
    231 / 3587 (6.44%)
    93 / 3587 (2.59%)
         occurrences all number
    279
    105
    Vascular disorders
    HYPERTENSION
         subjects affected / exposed
    165 / 3587 (4.60%)
    183 / 3587 (5.10%)
         occurrences all number
    182
    197
    Cardiac disorders
    ANGINA PECTORIS
         subjects affected / exposed
    220 / 3587 (6.13%)
    223 / 3587 (6.22%)
         occurrences all number
    253
    258
    General disorders and administration site conditions
    NON−CARDIAC CHEST PAIN
         subjects affected / exposed
    198 / 3587 (5.52%)
    224 / 3587 (6.24%)
         occurrences all number
    248
    265
    OEDEMA PERIPHERAL
         subjects affected / exposed
    470 / 3587 (13.10%)
    225 / 3587 (6.27%)
         occurrences all number
    544
    266
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    579 / 3587 (16.14%)
    389 / 3587 (10.84%)
         occurrences all number
    1555
    1004

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Feb 2013
    Added a study drug discontinuation criterion for patients who experienced a serious GI hemorrhage. This was done to address advice received from the Data Safety Monitoring Board. 25-Feb-2013

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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