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    Clinical Trial Results:
    A Multicenter, Double-Blind, Randomized Study to Establish the Clinical Benefit and Safety of Vytorin (Ezetimibe/Simvastatin Tablet) vs Simvastatin Monotherapy in High-Risk Subjects Presenting With Acute Coronary Syndrome (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial – IMPROVE IT)

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2005-001059-39
    Trial protocol
    FI   DK   SE   ES   BE   CZ   IT   DE   GB   AT   PT   SK   EE  
    Global end of trial date
    18 Sep 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    06 Mar 2016
    First version publication date
    06 Mar 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P04103
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00202878
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    Merck Study Number: MK-0653A-080
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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
    18 Sep 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Sep 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the clinical benefit of Ezetimibe/Simvastatin Combination (single tablet containing ezetimibe and simvastatin) compared with simvastatin in stabilized acute coronary syndrome (ACS) participants – either acute myocardial infarction (MI) or unstable angina (UA). Clinical benefit was defined as the reduction in the risk of the occurrence of the composite endpoint of cardiovascular (CV) death, major coronary events, and non-fatal stroke. CV death, major coronary events, and non-fatal stroke were designated primary endpoint events. Major coronary events included non-fatal myocardial infarction (MI), documented unstable angina that required admission into a hospital, and all coronary revascularization with either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) that occurred at least 30 days after randomized treatment assignment.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    17 Oct 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 332
    Country: Number of subjects enrolled
    Australia: 116
    Country: Number of subjects enrolled
    Austria: 249
    Country: Number of subjects enrolled
    Belgium: 249
    Country: Number of subjects enrolled
    Brazil: 423
    Country: Number of subjects enrolled
    Canada: 1107
    Country: Number of subjects enrolled
    Chile: 152
    Country: Number of subjects enrolled
    Colombia: 568
    Country: Number of subjects enrolled
    Czech Republic: 371
    Country: Number of subjects enrolled
    Denmark: 576
    Country: Number of subjects enrolled
    Ecuador: 45
    Country: Number of subjects enrolled
    Estonia: 10
    Country: Number of subjects enrolled
    Finland: 342
    Country: Number of subjects enrolled
    France: 286
    Country: Number of subjects enrolled
    Hong Kong: 58
    Country: Number of subjects enrolled
    Hungary: 116
    Country: Number of subjects enrolled
    India: 260
    Country: Number of subjects enrolled
    Israel: 655
    Country: Number of subjects enrolled
    Italy: 593
    Country: Number of subjects enrolled
    Germany: 935
    Country: Number of subjects enrolled
    Malaysia: 59
    Country: Number of subjects enrolled
    Netherlands: 1191
    Country: Number of subjects enrolled
    New Zealand: 164
    Country: Number of subjects enrolled
    Norway: 295
    Country: Number of subjects enrolled
    Peru: 65
    Country: Number of subjects enrolled
    Poland: 589
    Country: Number of subjects enrolled
    Portugal: 102
    Country: Number of subjects enrolled
    Singapore: 75
    Country: Number of subjects enrolled
    Slovakia: 121
    Country: Number of subjects enrolled
    South Africa: 186
    Country: Number of subjects enrolled
    Korea, Republic of: 118
    Country: Number of subjects enrolled
    Spain: 551
    Country: Number of subjects enrolled
    Sweden: 480
    Country: Number of subjects enrolled
    Switzerland: 265
    Country: Number of subjects enrolled
    Taiwan: 46
    Country: Number of subjects enrolled
    Turkey: 50
    Country: Number of subjects enrolled
    Ukraine: 159
    Country: Number of subjects enrolled
    United Kingdom: 319
    Country: Number of subjects enrolled
    United States: 5866
    Worldwide total number of subjects
    18144
    EEA total number of subjects
    7375
    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)
    10173
    From 65 to 84 years
    7706
    85 years and over
    265

    Subject disposition

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    Recruitment
    Recruitment details
    Adult men and women presenting with non-ST segment elevation myocardial infarction (NSTEMI) , STEMI, or hospitalized, documented unstable angina (UA) whom a percutaneous coronary intervention (PCI) was planned as management for the qualifying acute coronary syndrome (ACS) event were eligible for entry into the trial.

    Pre-assignment
    Screening details
    Study continued until a minimum of 5,250 participants had a primary endpoint event and each participant was followed for a minimum of 2.5 years.

    Period 1
    Period 1 title
    Overall (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
    Ezetimibe/simvastatin
    Arm description
    One ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
    Arm type
    Experimental

    Investigational medicinal product name
    Ezetimibe 10 mg/simvastatin 40 mg
    Investigational medicinal product code
    Other name
    SCH 465981, MK-0653A, Vytorin
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ezetimibe/simvastatin 10/40 mg per day from randomization through the end of participation.

    Investigational medicinal product name
    Placebo for simvastatin 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One or two tablets orally daily from randomization through the end of participation.

    Arm title
    Simvastatin
    Arm description
    One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
    Arm type
    Active comparator

    Investigational medicinal product name
    Simvastatin
    Investigational medicinal product code
    Other name
    Zocor
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Simvastatin 40 mg per day from randomization through the end of participation.

    Investigational medicinal product name
    Placebo for simvastatin 40 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One or two tablets orally daily from randomization through the end of participation.

    Investigational medicinal product name
    Placebo for ezetimibe 10 mg/simvastatin 40 mg combination
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    One tablet orally daily from randomization through the end of participation.

    Number of subjects in period 1
    Ezetimibe/simvastatin Simvastatin
    Started
    9067
    9077
    Completed
    6868
    6860
    Not completed
    2199
    2217
         Site Closure
             39
             36
         Adverse event, serious fatal
             964
             968
         Consent withdrawn by subject
             795
             808
         Only Vital Status Known
             357
             356
         Lost to follow-up
             44
             49

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ezetimibe/simvastatin
    Reporting group description
    One ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.

    Reporting group title
    Simvastatin
    Reporting group description
    One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.

    Reporting group values
    Ezetimibe/simvastatin Simvastatin Total
    Number of subjects
    9067 9077 18144
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    63.6 ± 9.7 63.6 ± 9.8 -
    Gender categorical
    Units: Subjects
        Female
    2225 2191 4416
        Male
    6842 6886 13728

    End points

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    End points reporting groups
    Reporting group title
    Ezetimibe/simvastatin
    Reporting group description
    One ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.

    Reporting group title
    Simvastatin
    Reporting group description
    One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.

    Primary: Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)

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    End point title
    Time to First Occurrence of Cardiovascular Death, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)
    End point description
    The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: cardiovascular death (CV), major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, major coronary event, or non-fatal stroke within 7 years from randomization.
    End point type
    Primary
    End point timeframe
    Up to approximately 9 years
    End point values
    Ezetimibe/simvastatin Simvastatin
    Number of subjects analysed
    9067
    9077
    Units: Percentage of Participants
        number (confidence interval 95%)
    32.72 (31.63 to 33.85)
    34.67 (33.56 to 35.81)
    Statistical analysis title
    Hazard Ratio
    Comparison groups
    Simvastatin v Ezetimibe/simvastatin
    Number of subjects included in analysis
    18144
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    = 0.016
    Method
    Cox proportional hazard model
    Parameter type
    Cox proportional hazard
    Point estimate
    0.936
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.887
         upper limit
    0.988
    Notes
    [1] - Cox proportional hazard model with covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment. Model includes events from randomization to last study visit.

    Secondary: Time to First Occurrence of Death from Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)

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    End point title
    Time to First Occurrence of Death from Any Cause, Major Coronary Event, or Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)
    End point description
    The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: death from any cause, major coronary event (non-fatal myocardial infarction, documented unstable angina requiring hospitalization, or coronary revascularization with percutaneous coronary intervention or coronary artery bypass grafting ≥ 30 days after randomization), or non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced death from any cause, major coronary event, or non-fatal stroke within 7 years from randomization.
    End point type
    Secondary
    End point timeframe
    Up to approximately 9 years
    End point values
    Ezetimibe/simvastatin Simvastatin
    Number of subjects analysed
    9067
    9077
    Units: Percentage of Participants
        number (confidence interval 95%)
    38.65 (37.52 to 39.81)
    40.25 (39.11 to 41.41)
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    Cox proportional hazard model with covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment. Model includes events from randomization to last study visit.
    Comparison groups
    Ezetimibe/simvastatin v Simvastatin
    Number of subjects included in analysis
    18144
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.035
    Method
    Cox proportional hazard model
    Parameter type
    Cox proportional hazard
    Point estimate
    0.948
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.903
         upper limit
    0.996

    Secondary: Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization with PCI or CABG ≥ 30 days after Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)

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    End point title
    Time to First Occurrence of Coronary Heart Disease (CHD) Death, Non-fatal MI, or Urgent Coronary Revascularization with PCI or CABG ≥ 30 days after Randomization (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)
    End point description
    The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CHD death, non-fatal MI, or urgent coronary revascularization with PCI or CABG ≥ 30 days after randomization within 7 years from randomization.
    End point type
    Secondary
    End point timeframe
    Up to approximately 9 years
    End point values
    Ezetimibe/simvastatin Simvastatin
    Number of subjects analysed
    9067
    9077
    Units: Percentage of Participants
        number (confidence interval 95%)
    17.52 (16.62 to 18.46)
    18.88 (17.96 to 19.83)
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    Cox proportional hazard model with covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment. Model includes events from randomization to last study visit.
    Comparison groups
    Ezetimibe/simvastatin v Simvastatin
    Number of subjects included in analysis
    18144
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.016
    Method
    Cox proportional hazard model
    Parameter type
    Cox proportional hazard
    Point estimate
    0.912
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.847
         upper limit
    0.983

    Secondary: Time to First Occurrence of CV Death, Nonfatal MI, UA with Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)

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    End point title
    Time to First Occurrence of CV Death, Nonfatal MI, UA with Hospitalization, All Revascularization Occurring ≥30 Days After Randomization, and Non-fatal Stroke (Kaplan-Meier Estimate of Percentage of Participants Experiencing a Qualifying Event)
    End point description
    The time (in months) from study start to the first occurrence of any of the following clinical outcomes was recorded: CV death, non-fatal MI, documented UA that requires admission into a hospital, all revascularization (including non-coronary) occurring at least 30 days after randomization, and non-fatal stroke. A Clinical Endpoints Committee (CEC) reviewed and adjudicated each suspected efficacy endpoint event while blinded to treatment. Participants who did not have any endpoint event until last visit or who were lost to follow-up and had no event were censored at the time of last available information (last study visit). The Kaplan-Meier estimate reports the percentage of participants who experienced CV death, non-fatal MI, unstable angina with hospitalization, all revascularization occurring ≥ 30 days after randomization, and non-fatal stroke within 7 Years from randomization.
    End point type
    Secondary
    End point timeframe
    Up to approximately 9 years
    End point values
    Ezetimibe/simvastatin Simvastatin
    Number of subjects analysed
    9067
    9077
    Units: Percentage of Participants
        number (confidence interval 95%)
    34.49 (33.38 to 35.63)
    36.2 (35.07 to 37.34)
    Statistical analysis title
    Hazard Ratio
    Statistical analysis description
    Cox proportional hazard model with covariates of the stratification factors (EARLY ACS trial, chronic prescription lipid-lowering experience, and high-risk ACS diagnosis) and treatment. Model includes events from randomization to last study visit.
    Comparison groups
    Ezetimibe/simvastatin v Simvastatin
    Number of subjects included in analysis
    18144
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.035
    Method
    Cox proportional hazard model
    Parameter type
    Cox proportional hazard
    Point estimate
    0.945
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.897
         upper limit
    0.996

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 30 days after last dose of study drug (Up to approximately 9 years maximum)
    Adverse event reporting additional description
    Safety Population included all participants randomly assigned to a treatment arm.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Ezetimibe/Simvastatin
    Reporting group description
    One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.

    Reporting group title
    Simvastatin
    Reporting group description
    One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.

    Serious adverse events
    Ezetimibe/Simvastatin Simvastatin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3640 / 9067 (40.15%)
    3649 / 9077 (40.20%)
         number of deaths (all causes)
    347
    325
         number of deaths resulting from adverse events
    10
    16
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (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
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    4 / 9067 (0.04%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Postoperative
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic Leak
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic Stenosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    8 / 9067 (0.09%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal Bite
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Contusion
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon Monoxide Poisoning
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod Sting
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursa Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    7 / 9067 (0.08%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    5 / 9067 (0.06%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical Poisoning
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chance Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electric Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epicondylitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Penetration
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Restenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    4 / 9067 (0.04%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    19 / 9067 (0.21%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    10 / 9067 (0.11%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fat Embolism
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    11 / 9067 (0.12%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    5 / 9067 (0.06%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    2 / 9067 (0.02%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured Sacrum
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured Ischium
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    3 / 9067 (0.03%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat Illness
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat Exhaustion
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    11 / 9067 (0.12%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand Fracture
         subjects affected / exposed
    5 / 9067 (0.06%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Radiation
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Anastomotic Leak
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional Hernia, Obstructive
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    5 / 9067 (0.06%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision Site Haematoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    7 / 9067 (0.08%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    28 / 9067 (0.31%)
    23 / 9077 (0.25%)
         occurrences causally related to treatment / all
    0 / 28
    1 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Heat Stroke
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    6 / 9067 (0.07%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Jaw Fracture
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    8 / 9067 (0.09%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney Contusion
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation Of Wound
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney Rupture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    5 / 9067 (0.06%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Traumatic Amputation
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    6 / 9067 (0.07%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Crushing Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Rupture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    8 / 9067 (0.09%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth Injury
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    1 / 9067 (0.01%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Multiple Injuries
         subjects affected / exposed
    2 / 9067 (0.02%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lumbar Vertebral Fracture
         subjects affected / exposed
    7 / 9067 (0.08%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    6 / 9067 (0.07%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Leak
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    9 / 9067 (0.10%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open Fracture
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Strain
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Near Drowning
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Concussion Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Osteolysis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Nerve Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Laminectomy Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    4 / 9067 (0.04%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post Procedural Haematuria
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmastectomy Lymphoedema Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Gastric Surgery Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Ileus
         subjects affected / exposed
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpericardiotomy Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Intestinal Perforation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thoracic Procedure Complication
         subjects affected / exposed
    6 / 9067 (0.07%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    18 / 9067 (0.20%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Haematoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    4 / 9067 (0.04%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation Proctitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Contusion
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    15 / 9067 (0.17%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Scapula Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Haematoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt Malfunction
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skeletal Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silicosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    7 / 9067 (0.08%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Snake Bite
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Injury Cauda Equina
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Injury
         subjects affected / exposed
    4 / 9067 (0.04%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Injury
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    4 / 9067 (0.04%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic Rupture
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Haematoma
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma Site Ulcer
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal Injury
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture Related Complication
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial Rupture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    7 / 9067 (0.08%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Injury
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    1 / 9067 (0.01%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Fracture
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (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
    4 / 9067 (0.04%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    7 / 9067 (0.08%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy Malfunction
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transfusion Reaction
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haematoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    4 / 9067 (0.04%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Graft Occlusion
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    11 / 9067 (0.12%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention Postoperative
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Rupture
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haemorrhage
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haematoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm Ruptured
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    4 / 9067 (0.04%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    4 / 9067 (0.04%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    3 / 4
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation Drug Level Below Therapeutic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine Aminotransferase Increased
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Abnormal
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Lactate Dehydrogenase Increased
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Increased
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Urine Present
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Pressure Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Body Temperature Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood Pressure Orthostatic Decreased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram Repolarisation Abnormality
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram Qt Prolonged
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection Fraction Decreased
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Test Positive
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy Gastrointestinal
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Examination
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart Rate Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart Rate Irregular
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    3 / 9067 (0.03%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International Normalised Ratio Decreased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart Rate Decreased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laboratory Test Abnormal
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Function Test Abnormal
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    3 / 4
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult Blood Positive
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Precancerous Cells Present
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International Normalised Ratio Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric Evaluation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    6 / 9067 (0.07%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour Marker Increased
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases Increased
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    2 / 2
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Total Lung Capacity Decreased
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Increased
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Adams-Stokes Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Stenosis
         subjects affected / exposed
    7 / 9067 (0.08%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    11 / 9067 (0.12%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Thrombosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    24 / 9067 (0.26%)
    28 / 9077 (0.31%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    140 / 9067 (1.54%)
    150 / 9077 (1.65%)
         occurrences causally related to treatment / all
    0 / 140
    0 / 150
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arrhythmia Supraventricular
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    4 / 9067 (0.04%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    27 / 9067 (0.30%)
    30 / 9077 (0.33%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Dissociation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    5 / 9067 (0.06%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block First Degree
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    13 / 9067 (0.14%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Aneurysm
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Left
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    5 / 9067 (0.06%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Pseudoaneurysm
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    5 / 9067 (0.06%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardio-Respiratory Arrest
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac Ventricular Thrombosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Tamponade
         subjects affected / exposed
    2 / 9067 (0.02%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coronary Artery Dissection
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Congestive Cardiomyopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronotropic Incompetence
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Thrombosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Perforation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Cardiomyopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's Syndrome
         subjects affected / exposed
    3 / 9067 (0.03%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    4 / 9067 (0.04%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Dysfunction
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    2 / 9067 (0.02%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac Thrombus
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Stenosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis Constrictive
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    14 / 9067 (0.15%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Haemorrhage
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pericardial Effusion
         subjects affected / exposed
    10 / 9067 (0.11%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    9 / 9067 (0.10%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Extrasystoles
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Tachycardia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Arrhythmia
         subjects affected / exposed
    4 / 9067 (0.04%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Arrest
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick Sinus Syndrome
         subjects affected / exposed
    17 / 9067 (0.19%)
    19 / 9077 (0.21%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    7 / 9067 (0.08%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    16 / 9067 (0.18%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Torsade De Pointes
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia Paroxysmal
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    2 / 9067 (0.02%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachyarrhythmia
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    3 / 9067 (0.03%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    10 / 9067 (0.11%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wolff-Parkinson-White Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    29 / 9067 (0.32%)
    42 / 9077 (0.46%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 42
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Trifascicular Block
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Congenital, familial and genetic disorders
    Arteriovenous Malformation
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Septal Defect
         subjects affected / exposed
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicuspid Aortic Valve
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital Spinal Cord Anomaly
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermoid Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomatous Polyposis Coli
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foramen Magnum Stenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Arteriovenous Malformation
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    7 / 9067 (0.08%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic Cardiomyopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Lentigines Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epidermal Naevus
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Septal Defect
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sickle Cell Anaemia With Crisis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    2 / 9067 (0.02%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Chronic Disease
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Malignant Disease
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Megaloblastic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    71 / 9067 (0.78%)
    55 / 9077 (0.61%)
         occurrences causally related to treatment / all
    1 / 71
    1 / 55
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Macrocytic
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Diathesis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic Anaemia
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercoagulation
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hilar Lymphadenopathy
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heparin-Induced Thrombocytopenia
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune Thrombocytopenic Purpura
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypereosinophilic Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukocytosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic Anaemia
         subjects affected / exposed
    4 / 9067 (0.04%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic Anaemia
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoid Tissue Hyperplasia
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy Mediastinal
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    5 / 9067 (0.06%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Mastocytosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic Vein Thrombosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic Lesion
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal Lymphadenopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombocytopenic Purpura
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Amnesia
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Occlusion
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Injury
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Aneurysm
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autonomic Nervous System Imbalance
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arachnoid Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Sinus Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    3 / 9067 (0.03%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central Nervous System Lesion
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal Fluid Leakage
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Cord Compression
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    9 / 9067 (0.10%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Myelopathy
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Radiculopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (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
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complex Partial Seizures
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    12 / 9067 (0.13%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Complicated Migraine
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelination
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Coma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Hyperglycaemic Coma
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    4 / 9067 (0.04%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    30 / 9067 (0.33%)
    30 / 9077 (0.33%)
         occurrences causally related to treatment / all
    0 / 30
    1 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's Type
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Guillain-Barre Syndrome
         subjects affected / exposed
    4 / 9067 (0.04%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand Mal Convulsion
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paresis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Encephalopathy
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Encephalopathy
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hemiparesis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    11 / 9067 (0.12%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal Neuralgia
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Aneurysm
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoencephalopathy
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    6 / 9067 (0.07%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Migraine With Aura
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    2 / 9067 (0.02%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Encephalopathy
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Sclerosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor Neurone Disease
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological Symptom
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous System Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Spasticity
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (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
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occipital Neuralgia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal Pressure Hydrocephalus
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuropathy Peripheral
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineurial Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Paralysis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocephalus
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Polyneuropathy
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's Disease
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    4 / 9067 (0.04%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy Chronic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial Nerve Palsy
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Polio Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    16 / 9067 (0.18%)
    20 / 9077 (0.22%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tarsal Tunnel Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    107 / 9067 (1.18%)
    96 / 9077 (1.06%)
         occurrences causally related to treatment / all
    0 / 107
    0 / 96
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic Myelopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Ischaemia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Dementia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unresponsive To Stimuli
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Encephalopathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension Headache
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viith Nerve Paralysis
         subjects affected / exposed
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paresis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Artery Stenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blepharitis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness Transient
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    15 / 9067 (0.17%)
    17 / 9077 (0.19%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Nuclear
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal Scar
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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
    5 / 9067 (0.06%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Disorder
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exfoliation Glaucoma
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens Dislocation
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular Degeneration
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Haemorrhage
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    4 / 9067 (0.04%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic Ischaemic Neuropathy
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Artery Occlusion
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Impairment
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloedema
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Disorder
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness Unilateral
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness Neurosensory
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Hearing Loss
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otorrhoea
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle Ear Effusion
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inner Ear Inflammation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inner Ear Disorder
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    5 / 9067 (0.06%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    19 / 9067 (0.21%)
    25 / 9077 (0.28%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Distension
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Adhesions
         subjects affected / exposed
    4 / 9067 (0.04%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Mass
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (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
    41 / 9067 (0.45%)
    43 / 9077 (0.47%)
         occurrences causally related to treatment / all
    3 / 41
    1 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal Pain Lower
         subjects affected / exposed
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Hernia
         subjects affected / exposed
    15 / 9067 (0.17%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    21 / 9067 (0.23%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    1 / 21
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Polyp
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (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
    4 / 9067 (0.04%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Haematoma
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's Oesophagus
         subjects affected / exposed
    0 / 9067 (0.00%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ascites
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Ulcer
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Stenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Prolapse
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bezoar
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    14 / 9067 (0.15%)
    15 / 9077 (0.17%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    7 / 9067 (0.08%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    9 / 9067 (0.10%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    8 / 9067 (0.09%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coeliac Disease
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowel Movement Irregularity
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    23 / 9067 (0.25%)
    15 / 9077 (0.17%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic Hernia
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (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 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental Caries
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyclic Vomiting Syndrome
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    2 / 9067 (0.02%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    11 / 9067 (0.12%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis Intestinal Haemorrhagic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Oesophageal
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Polyp
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    7 / 9067 (0.08%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Perforation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    3 / 9067 (0.03%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocele
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    5 / 9067 (0.06%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    5 / 9067 (0.06%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    5 / 9067 (0.06%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    11 / 9067 (0.12%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenogastric Reflux
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Oesophagitis
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Haemorrhagic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 9067 (0.02%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric Discomfort
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Hernia
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Disorder
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Haemorrhage
         subjects affected / exposed
    3 / 9067 (0.03%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal Incontinence
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Polyps
         subjects affected / exposed
    3 / 9067 (0.03%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    12 / 9067 (0.13%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Perforation
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Perforation
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    4 / 9067 (0.04%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    29 / 9067 (0.32%)
    39 / 9077 (0.43%)
         occurrences causally related to treatment / all
    1 / 29
    2 / 39
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Angiodysplasia
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal Ulcer
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    4 / 9067 (0.04%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Haemorrhagic
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Pain
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Oedema
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Obstruction
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Necrosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Hypomotility
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    60 / 9067 (0.66%)
    64 / 9077 (0.71%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 64
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Gastrointestinal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    27 / 9067 (0.30%)
    33 / 9077 (0.36%)
         occurrences causally related to treatment / all
    0 / 27
    2 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival Bleeding
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    6 / 9067 (0.07%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Perforation
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic Anal Papilla
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    10 / 9067 (0.11%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial Eventration
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids Thrombosed
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    8 / 9067 (0.09%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    4 / 9067 (0.04%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    69 / 9067 (0.76%)
    51 / 9077 (0.56%)
         occurrences causally related to treatment / all
    0 / 69
    0 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory Bowel Disease
         subjects affected / exposed
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Gastric Emptying
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileus
         subjects affected / exposed
    11 / 9067 (0.12%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Ulcer
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia, Obstructive
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Infarction
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haematoma
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Fistula
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Dilatation
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intestinal Mass
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    15 / 9067 (0.17%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal Perforation
         subjects affected / exposed
    4 / 9067 (0.04%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Polyp
         subjects affected / exposed
    2 / 9067 (0.02%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    40 / 9067 (0.44%)
    58 / 9077 (0.64%)
         occurrences causally related to treatment / all
    2 / 40
    1 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    4 / 9067 (0.04%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Large Intestinal Ulcer
         subjects affected / exposed
    0 / 9067 (0.00%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Stenosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Stenosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Artery Stenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Artery Embolism
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    10 / 9067 (0.11%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss Syndrome
         subjects affected / exposed
    5 / 9067 (0.06%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Hernia
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    16 / 9067 (0.18%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mouth Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth Haemorrhage
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    8 / 9067 (0.09%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous Pancreatitis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Achalasia
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Spasm
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteritis
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Motility Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Obstruction
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Perforation
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Rupture
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    7 / 9067 (0.08%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Ulcer
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Cyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Stenosis
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral Disorder
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Necrotising
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    1 / 9067 (0.01%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    13 / 9067 (0.14%)
    17 / 9077 (0.19%)
         occurrences causally related to treatment / all
    3 / 13
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    35 / 9067 (0.39%)
    28 / 9077 (0.31%)
         occurrences causally related to treatment / all
    10 / 35
    6 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic Pseudocyst
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Mass
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pharyngo-Oesophageal Diverticulum
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 1