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    Clinical Trial Results:
    Effect of ivabradine in patients with stable coronary artery disease without clinical heart failure. A randomised double-blind placebo-controlled international multicentre study. Study assessInG the morbi-mortality beNefits of the If inhibitor ivabradine in patients with coronary arterY disease (SIGNIFY).

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    2009-011360-10
    Trial protocol
    ES   PT   GB   NL   FI   LV   HU   CZ   SK   IE   BE   FR   LT   DE   AT   SE   IT   GR   EE   SI   BG   DK   NO  
    Global end of trial date
    24 Jan 2014

    Results information
    Results version number
    v2(current)
    This version publication date
    22 Jul 2016
    First version publication date
    31 Jul 2015
    Other versions
    v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    Data correction due to a system error in EudraCT – Results

    Trial information

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    Trial identification
    Sponsor protocol code
    CL3-16257-083
    Additional study identifiers
    ISRCTN number
    ISRCTN61576291
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Institut de Recherches Internationales Servier
    Sponsor organisation address
    50 rue Carnot, Suresnes Cedex, France, 92284
    Public contact
    Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.com
    Scientific contact
    Therapeutic Innovation Pole, Institut de Recherches Internationales Servier 50 rue Carnot 92284 Suresnes Cedex, +33 155724366, clinicaltrials@servier.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
    24 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Jan 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the superiority of ivabradine over placebo in the reduction of CV mortality or non-fatal myocardial infarction.
    Protection of trial subjects
    Reason to discontinue the study treatment: study drug not tolerated, no longer appropriate or considered as contra-indicated. The measurement of drug concentrations in blood was planned in the case of suspected overdose.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Sep 2009
    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
    Korea, Republic of: 446
    Country: Number of subjects enrolled
    Kazakhstan: 141
    Country: Number of subjects enrolled
    Latvia: 440
    Country: Number of subjects enrolled
    Lithuania: 302
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 224
    Country: Number of subjects enrolled
    Malaysia: 74
    Country: Number of subjects enrolled
    Mexico: 559
    Country: Number of subjects enrolled
    Netherlands: 555
    Country: Number of subjects enrolled
    Norway: 56
    Country: Number of subjects enrolled
    Philippines: 30
    Country: Number of subjects enrolled
    Poland: 1157
    Country: Number of subjects enrolled
    Portugal: 27
    Country: Number of subjects enrolled
    Romania: 892
    Country: Number of subjects enrolled
    Russian Federation: 2119
    Country: Number of subjects enrolled
    Serbia: 210
    Country: Number of subjects enrolled
    Singapore: 21
    Country: Number of subjects enrolled
    Slovenia: 68
    Country: Number of subjects enrolled
    South Africa: 374
    Country: Number of subjects enrolled
    Spain: 235
    Country: Number of subjects enrolled
    Sweden: 57
    Country: Number of subjects enrolled
    Switzerland: 50
    Country: Number of subjects enrolled
    Taiwan: 198
    Country: Number of subjects enrolled
    Thailand: 96
    Country: Number of subjects enrolled
    Turkey: 96
    Country: Number of subjects enrolled
    Ukraine: 1894
    Country: Number of subjects enrolled
    United Kingdom: 118
    Country: Number of subjects enrolled
    Uruguay: 29
    Country: Number of subjects enrolled
    Vietnam: 171
    Country: Number of subjects enrolled
    Argentina: 954
    Country: Number of subjects enrolled
    Armenia: 239
    Country: Number of subjects enrolled
    Australia: 116
    Country: Number of subjects enrolled
    Austria: 19
    Country: Number of subjects enrolled
    Belgium: 52
    Country: Number of subjects enrolled
    Brazil: 853
    Country: Number of subjects enrolled
    Bulgaria: 1121
    Country: Number of subjects enrolled
    Canada: 254
    Country: Number of subjects enrolled
    China: 975
    Country: Number of subjects enrolled
    Croatia: 197
    Country: Number of subjects enrolled
    Czech Republic: 539
    Country: Number of subjects enrolled
    Denmark: 76
    Country: Number of subjects enrolled
    Estonia: 387
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    France: 99
    Country: Number of subjects enrolled
    Georgia: 102
    Country: Number of subjects enrolled
    Germany: 309
    Country: Number of subjects enrolled
    Greece: 77
    Country: Number of subjects enrolled
    Hungary: 981
    Country: Number of subjects enrolled
    Slovakia: 379
    Country: Number of subjects enrolled
    India: 295
    Country: Number of subjects enrolled
    Ireland: 47
    Country: Number of subjects enrolled
    Italy: 384
    Worldwide total number of subjects
    19102
    EEA total number of subjects
    8582
    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)
    10205
    From 65 to 84 years
    8789
    85 years and over
    108

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 1181 centres in 51 countries screened at least one patient and 1139 centres included at least one patient.

    Pre-assignment
    Screening details
    A total of 23 164 patients were screened, 21 862 were selected and 19 107 were included. The Randomised Set comprised 19 102 patients: 9550 patients in the ivabradine group and 9552 in the placebo group. Of the 19 102 patients in the Randomised Set, 17 724 completed the study: 8830 patients in the ivabradine group and 8894 in the placebo group.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Ivabradine
    Arm description
    Patients taking Ivabradine
    Arm type
    Study drug

    Investigational medicinal product name
    Ivabradine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily at 12-hours intervals, in the morning and in the evening during meals.

    Arm title
    Placebo
    Arm description
    Patients taking placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg, 7.5 mg or 10 mg matching tablets to be taken orally twice daily at 12-hours intervals, in the morning and in the evening during meals.

    Number of subjects in period 1
    Ivabradine Placebo
    Started
    9550
    9552
    Completed
    8830
    8894
    Not completed
    720
    658
         Physician decision
    1
    -
         Adverse event, serious fatal
    485
    458
         Consent withdrawn by subject
    231
    199
         Lost to follow-up
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ivabradine
    Reporting group description
    Patients taking Ivabradine

    Reporting group title
    Placebo
    Reporting group description
    Patients taking placebo

    Reporting group values
    Ivabradine Placebo Total
    Number of subjects
    9550 9552 19102
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    5109 5096 10205
        From 65-84 years
    4387 4402 8789
        85 years and over
    54 54 108
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65 ± 7.2 65 ± 7.3 -
    Gender categorical
    Units: Subjects
        Female
    2601 2662 5263
        Male
    6949 6890 13839
    Subject analysis sets

    Subject analysis set title
    Randomised set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All included patients with a randomisation number allocated by the IRS.

    Subject analysis set title
    Safety set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients having received at least one dose of study drug.

    Subject analysis set title
    Randomised set angina
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All symptomatic angina patients of the RS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).

    Subject analysis set title
    Safety set angina
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All symptomatic angina patients of the SS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).

    Subject analysis sets values
    Randomised set Safety set Randomised set angina Safety set angina
    Number of subjects
    19102
    19083
    1204
    1203
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    5109
        From 65-84 years
    4387
        85 years and over
    54
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    65 ± 7.2
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    5263
        Male
    13839

    End points

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    End points reporting groups
    Reporting group title
    Ivabradine
    Reporting group description
    Patients taking Ivabradine

    Reporting group title
    Placebo
    Reporting group description
    Patients taking placebo

    Subject analysis set title
    Randomised set
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All included patients with a randomisation number allocated by the IRS.

    Subject analysis set title
    Safety set
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All patients having received at least one dose of study drug.

    Subject analysis set title
    Randomised set angina
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All symptomatic angina patients of the RS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).

    Subject analysis set title
    Safety set angina
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    All symptomatic angina patients of the SS having a CCS class ≥ II at baseline (defined as CCS class ≥ II at selection and inclusion).

    Primary: Primary composite endpoint

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    End point title
    Primary composite endpoint
    End point description
    First event among cardiovascular death or non-fatal MI
    End point type
    Primary
    End point timeframe
    All criteria are expressed as the time to first event, defined as the duration between the date of randomisation and the date of first occurrence of this event.
    End point values
    Ivabradine Placebo
    Number of subjects analysed
    9550
    9552
    Units: number of events
    654
    611
    Statistical analysis title
    Superiority of Ivabradine versus Placebo
    Comparison groups
    Ivabradine v Placebo
    Number of subjects included in analysis
    19102
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.1969
    Method
    Regression, Cox
    Parameter type
    Cox proportional hazard
    Point estimate
    1.08
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.96
         upper limit
    1.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.06

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On treatment
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Ivabradine
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    <
    Serious adverse events
    Ivabradine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3379 / 9539 (35.42%)
    3263 / 9544 (34.19%)
         number of deaths (all causes)
    363
    356
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accident at home
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation postoperative
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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 / 9539 (0.00%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    6 / 9539 (0.06%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asbestosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness traumatic
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone fissure
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    4 / 9539 (0.04%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Burns second degree
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac contusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve replacement complication
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    6 / 9539 (0.06%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    9 / 9539 (0.09%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    9 / 9539 (0.09%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corrosive gastritis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 9539 (0.02%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crushing injury of trunk
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural haematoma
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye contusion
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye injury
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile nonhaemolytic transfusion reaction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    95 / 9539 (1.00%)
    109 / 9544 (1.14%)
         occurrences causally related to treatment / all
    4 / 96
    2 / 109
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    13 / 9539 (0.14%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    15 / 9539 (0.16%)
    10 / 9544 (0.10%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    4 / 9539 (0.04%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    5 / 9539 (0.05%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in eye
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    3 / 9539 (0.03%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    4 / 9539 (0.04%)
    10 / 9544 (0.10%)
         occurrences causally related to treatment / all
    1 / 4
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    6 / 9539 (0.06%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    4 / 9539 (0.04%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ilium fracture
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 9539 (0.00%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    4 / 9539 (0.04%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation postoperative
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney rupture
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (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
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb traumatic amputation
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    4 / 9539 (0.04%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    4 / 9539 (0.04%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meniscus injury
         subjects affected / exposed
    2 / 9539 (0.02%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Muscle rupture
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck injury
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoradionecrosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating abdominal trauma
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haematoma
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery restenosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    2 / 9539 (0.02%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural contusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    3 / 9539 (0.03%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural hypothyroidism
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    3 / 9539 (0.03%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural myocardial infarction
         subjects affected / exposed
    14 / 9539 (0.15%)
    13 / 9544 (0.14%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Post procedural pulmonary embolism
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-thoracotomy pain syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypertension
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural site reaction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation oesophagitis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    8 / 9539 (0.08%)
    15 / 9544 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    23 / 9539 (0.24%)
    26 / 9544 (0.27%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 26
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Rib fracture
         subjects affected / exposed
    8 / 9539 (0.08%)
    15 / 9544 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt thrombosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silicosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    3 / 9539 (0.03%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    5 / 9539 (0.05%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab wound
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    8 / 9539 (0.08%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Suture related complication
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 9539 (0.01%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    6 / 9539 (0.06%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue injury
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion reaction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Traumatic ulcer
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    3 / 9539 (0.03%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasoplegia syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound complication
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    11 / 9539 (0.12%)
    11 / 9544 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Amylase increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram carotid
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram coronary
         subjects affected / exposed
    43 / 9539 (0.45%)
    53 / 9544 (0.56%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthroscopy
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    12 / 9539 (0.13%)
    10 / 9544 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Biopsy prostate
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood alkaline phosphatase increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    3 / 9539 (0.03%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose decreased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    2 / 9539 (0.02%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood iron decreased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood parathyroid hormone decreased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure decreased
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    24 / 9539 (0.25%)
    13 / 9544 (0.14%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure systolic decreased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure systolic increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood triglycerides increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac enzymes increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbohydrate antigen 19-9 increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular evaluation
         subjects affected / exposed
    78 / 9539 (0.82%)
    84 / 9544 (0.88%)
         occurrences causally related to treatment / all
    0 / 98
    0 / 100
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystoscopy normal
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest X-ray abnormal
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    57 / 9539 (0.60%)
    18 / 9544 (0.19%)
         occurrences causally related to treatment / all
    42 / 60
    6 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram T wave inversion
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ambulatory
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram change
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram repolarisation abnormality
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal examination
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    2 / 9539 (0.02%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    55 / 9539 (0.58%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    40 / 55
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular pressure increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigation
         subjects affected / exposed
    7 / 9539 (0.07%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen saturation decreased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial pressure increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Red blood cell sedimentation rate increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Romberg test positive
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep study
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcus test positive
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress echocardiogram abnormal
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid function test abnormal
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Treponema test positive
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    5 / 9539 (0.05%)
    11 / 9544 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White blood cell count increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Accelerated idioventricular rhythm
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    17 / 9539 (0.18%)
    21 / 9544 (0.22%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 24
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    2 / 9539 (0.02%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    200 / 9539 (2.10%)
    208 / 9544 (2.18%)
         occurrences causally related to treatment / all
    2 / 216
    0 / 229
         deaths causally related to treatment / all
    0 / 23
    0 / 23
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    294 / 9539 (3.08%)
    330 / 9544 (3.46%)
         occurrences causally related to treatment / all
    3 / 314
    2 / 361
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angina unstable
         subjects affected / exposed
    409 / 9539 (4.29%)
    433 / 9544 (4.54%)
         occurrences causally related to treatment / all
    4 / 479
    0 / 524
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease mixed
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    3 / 9539 (0.03%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve sclerosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    12 / 9539 (0.13%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    49 / 9539 (0.51%)
    41 / 9544 (0.43%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    336 / 9539 (3.52%)
    232 / 9544 (2.43%)
         occurrences causally related to treatment / all
    22 / 381
    2 / 262
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    4 / 9539 (0.04%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    17 / 9539 (0.18%)
    13 / 9544 (0.14%)
         occurrences causally related to treatment / all
    4 / 17
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    22 / 9539 (0.23%)
    13 / 9544 (0.14%)
         occurrences causally related to treatment / all
    10 / 22
    7 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular dissociation
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    101 / 9539 (1.06%)
    21 / 9544 (0.22%)
         occurrences causally related to treatment / all
    91 / 102
    15 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    7 / 9539 (0.07%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    5 / 9539 (0.05%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    15 / 9539 (0.16%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac asthma
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    357 / 9539 (3.74%)
    346 / 9544 (3.63%)
         occurrences causally related to treatment / all
    13 / 415
    2 / 394
         deaths causally related to treatment / all
    0 / 16
    0 / 14
    Cardiac failure acute
         subjects affected / exposed
    37 / 9539 (0.39%)
    23 / 9544 (0.24%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 26
         deaths causally related to treatment / all
    0 / 7
    0 / 9
    Cardiac failure congestive
         subjects affected / exposed
    31 / 9539 (0.32%)
    24 / 9544 (0.25%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure chronic
         subjects affected / exposed
    25 / 9539 (0.26%)
    29 / 9544 (0.30%)
         occurrences causally related to treatment / all
    1 / 28
    0 / 36
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac tamponade
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    30 / 9539 (0.31%)
    22 / 9544 (0.23%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 22
         deaths causally related to treatment / all
    0 / 12
    0 / 9
    Cardiomegaly
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Congestive cardiomyopathy
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cor pulmonale
         subjects affected / exposed
    6 / 9539 (0.06%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    20 / 9539 (0.21%)
    25 / 9544 (0.26%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor pulmonale chronic
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    14 / 9539 (0.15%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    18 / 9539 (0.19%)
    26 / 9544 (0.27%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis noninfective
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    5 / 9539 (0.05%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    3 / 9539 (0.03%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left atrial dilatation
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    9 / 9539 (0.09%)
    10 / 9544 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low cardiac output syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    16 / 9539 (0.17%)
    14 / 9544 (0.15%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial depression
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    98 / 9539 (1.03%)
    83 / 9544 (0.87%)
         occurrences causally related to treatment / all
    0 / 104
    0 / 88
         deaths causally related to treatment / all
    0 / 15
    0 / 14
    Myocardial ischaemia
         subjects affected / exposed
    23 / 9539 (0.24%)
    27 / 9544 (0.28%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 27
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    5 / 9539 (0.05%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 9539 (0.03%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postinfarction angina
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhythm idioventricular
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    8 / 9539 (0.08%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    9 / 9539 (0.09%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    4 / 9
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silent myocardial infarction
         subjects affected / exposed
    5 / 9539 (0.05%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 9539 (0.00%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrest
         subjects affected / exposed
    9 / 9539 (0.09%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    8 / 9
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    48 / 9539 (0.50%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    42 / 49
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    6 / 9539 (0.06%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    8 / 9539 (0.08%)
    15 / 9544 (0.16%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    17 / 9539 (0.18%)
    21 / 9544 (0.22%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    6 / 9539 (0.06%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular extrasystoles
         subjects affected / exposed
    32 / 9539 (0.34%)
    21 / 9544 (0.22%)
         occurrences causally related to treatment / all
    2 / 32
    2 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular failure
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular fibrillation
         subjects affected / exposed
    20 / 9539 (0.21%)
    20 / 9544 (0.21%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 6
    Ventricular tachycardia
         subjects affected / exposed
    35 / 9539 (0.37%)
    21 / 9544 (0.22%)
         occurrences causally related to treatment / all
    3 / 39
    0 / 23
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Wolff-Parkinson-White syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Adenomatous polyposis coli
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital umbilical hernia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Factor V Leiden mutation
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic myopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyloric stenosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    30 / 9539 (0.31%)
    45 / 9544 (0.47%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia folate deficiency
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia megaloblastic
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone marrow failure
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deficiency anaemia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic diathesis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    14 / 9539 (0.15%)
    15 / 9544 (0.16%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    8 / 9539 (0.08%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoprothrombinaemia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    7 / 9539 (0.07%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    3 / 9539 (0.03%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphopenia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    4 / 9539 (0.04%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    4 / 9539 (0.04%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Platelet dysfunction
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sideroblastic anaemia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    15 / 9539 (0.16%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenic purpura
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    5 / 9539 (0.05%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Altered state of consciousness
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticholinergic syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autonomic neuropathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain hypoxia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 9539 (0.01%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid aneurysm rupture
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid arteriosclerosis
         subjects affected / exposed
    4 / 9539 (0.04%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery dissection
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    3 / 9539 (0.03%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    51 / 9539 (0.53%)
    43 / 9544 (0.45%)
         occurrences causally related to treatment / all
    0 / 57
    0 / 45
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    4 / 9539 (0.04%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar atrophy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery stenosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    3 / 9539 (0.03%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral infarction
         subjects affected / exposed
    15 / 9539 (0.16%)
    13 / 9544 (0.14%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral ischaemia
         subjects affected / exposed
    8 / 9539 (0.08%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral microangiopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    31 / 9539 (0.32%)
    40 / 9544 (0.42%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 44
         deaths causally related to treatment / all
    0 / 5
    0 / 5
    Cerebrovascular disorder
         subjects affected / exposed
    5 / 9539 (0.05%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical cord compression
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve paralysis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cubital tunnel syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    4 / 9539 (0.04%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia of the Alzheimer's type, with delusions
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelinating polyneuropathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic hyperglycaemic coma
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    10 / 9539 (0.10%)
    10 / 9544 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    19 / 9539 (0.20%)
    18 / 9544 (0.19%)
         occurrences causally related to treatment / all
    3 / 19
    3 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drop attacks
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dystonic tremor
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalomyelitis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    4 / 9539 (0.04%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    7 / 9539 (0.07%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential tremor
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal disorder
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial nerve disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (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
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paresis
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    5 / 9539 (0.05%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Headache
         subjects affected / exposed
    5 / 9539 (0.05%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia homonymous
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    6 / 9539 (0.06%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Horner's syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive encephalopathy
         subjects affected / exposed
    2 / 9539 (0.02%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    3 / 9539 (0.03%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    2 / 9539 (0.02%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypoglycaemic unconsciousness
         subjects affected / exposed
    4 / 9539 (0.04%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyporeflexia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    4 / 9539 (0.04%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial hypotension
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial venous sinus thrombosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic neuropathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    97 / 9539 (1.02%)
    90 / 9544 (0.94%)
         occurrences causally related to treatment / all
    1 / 100
    0 / 95
         deaths causally related to treatment / all
    0 / 13
    0 / 6
    Lacunar infarction
         subjects affected / exposed
    5 / 9539 (0.05%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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
    32 / 9539 (0.34%)
    22 / 9544 (0.23%)
         occurrences causally related to treatment / all
    3 / 32
    1 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    4 / 9539 (0.04%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Movement disorder
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelitis transverse
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root lesion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis cranial
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodegenerative disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological decompensation
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    6 / 9539 (0.06%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensorimotor neuropathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit mal epilepsy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poor quality sleep
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-injection delirium sedation syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic headache
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    15 / 9539 (0.16%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    4 / 15
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyramidal tract syndrome
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial nerve compression
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular pain
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    5 / 9539 (0.05%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retrograde amnesia
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 9539 (0.02%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Senile dementia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         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
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    4 / 9539 (0.04%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal vascular disorder
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    5 / 9539 (0.05%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    91 / 9539 (0.95%)
    89 / 9544 (0.93%)
         occurrences causally related to treatment / all
    23 / 102
    6 / 96
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombotic stroke
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic convulsion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 9539 (0.00%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    56 / 9539 (0.59%)
    50 / 9544 (0.52%)
         occurrences causally related to treatment / all
    3 / 59
    0 / 50
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar neurapraxia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar tunnel syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (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 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    3 / 9539 (0.03%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    11 / 9539 (0.12%)
    9 / 9544 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         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
    15 / 9539 (0.16%)
    12 / 9544 (0.13%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS origin
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord paresis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wernicke-Korsakoff syndrome
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    4 / 9539 (0.04%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle closure glaucoma
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    39 / 9539 (0.41%)
    32 / 9544 (0.34%)
         occurrences causally related to treatment / all
    0 / 43
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract diabetic
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract subcapsular
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroidal effusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choroidal neovascularisation
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryoadenitis acquired
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic glaucoma
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinal oedema
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    9 / 9539 (0.09%)
    18 / 9544 (0.19%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    20 / 9539 (0.21%)
    19 / 9544 (0.20%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucomatous optic disc atrophy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular degeneration
         subjects affected / exposed
    7 / 9539 (0.07%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular fibrosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular oedema
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal tension glaucoma
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular hypertension
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular icterus
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    3 / 9539 (0.03%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic atrophy
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmoplegia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital oedema
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photophobia
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pterygium
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photopsia
         subjects affected / exposed
    28 / 9539 (0.29%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    29 / 31
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal aneurysm
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    2 / 9539 (0.02%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery thrombosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    4 / 9539 (0.04%)
    6 / 9544 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    10 / 9539 (0.10%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal tear
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vascular thrombosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    1 / 9539 (0.01%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein thrombosis
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy haemorrhagic
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy hypertensive
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinoschisis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    13 / 9539 (0.14%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    11 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual acuity reduced
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    3 / 9539 (0.03%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous detachment
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous floaters
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    8 / 9539 (0.08%)
    4 / 9544 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    4 / 9539 (0.04%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness unilateral
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematotympanum
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hearing impaired
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    0 / 9539 (0.00%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurosensory hypoacusis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic membrane disorder
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    9 / 9539 (0.09%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    2 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular ataxia
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    2 / 9539 (0.02%)
    3 / 9544 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 9539 (0.02%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia obstructive
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    6 / 9539 (0.06%)
    7 / 9544 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    4 / 9539 (0.04%)
    8 / 9544 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal rigidity
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired oesophageal web
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal polyp
         subjects affected / exposed
    1 / 9539 (0.01%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal ulcer
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    3 / 9539 (0.03%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    2 / 9539 (0.02%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 9539 (0.02%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    3 / 9539 (0.03%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic pseudo-obstruction
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic stenosis
         subjects affected / exposed
    1 / 9539 (0.01%)
    0 / 9544 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 9539 (0.04%)
    5 / 9544 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 9539 (0.01%)
    2 / 9544 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental alveolar anomaly
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    0 / 9539 (0.00%)
    1 / 9544 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0