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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

    		 Close Top of page
    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
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Monocytic Leukaemia
         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
    Acute Leukaemia
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Abdominal Neoplasm
         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
    Acoustic Neuroma
         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
    Adenocarcinoma
         subjects affected / exposed
    12 / 9067 (0.13%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Adenocarcinoma Gastric
         subjects affected / exposed
    3 / 9067 (0.03%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    1 / 3
    Adenocarcinoma Of Colon
         subjects affected / exposed
    14 / 9067 (0.15%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma Pancreas
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Adenoma Benign
         subjects affected / exposed
    5 / 9067 (0.06%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenolymphoma
         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
    Acute Myeloid Leukaemia
         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 / 2
    0 / 4
    Adrenal Adenoma
         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
    Adrenal Gland Cancer
         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
    Adrenal Neoplasm
         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
    Anal Squamous Cell Carcinoma
         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
    Angiomyolipoma
         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
    Angiosarcoma
         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 / 1
    0 / 1
    Anal Cancer
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous Carcinoma
         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
    Basal Cell Carcinoma
         subjects affected / exposed
    140 / 9067 (1.54%)
    157 / 9077 (1.73%)
         occurrences causally related to treatment / all
    2 / 140
    3 / 157
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Small Lymphocytic Lymphoma
         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
    Atypical Fibroxanthoma
         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 / 1
    B-Cell Lymphoma Stage I
         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
    Benign Anorectal Neoplasm
         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
    Benign Bone Neoplasm
         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
    B-Cell Lymphoma
         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 / 1
    0 / 1
    Benign Neoplasm Of Bladder
         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
    Benign Neoplasm
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Lung Neoplasm
         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
    Benign Duodenal Neoplasm
         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
    Benign Breast Neoplasm
         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
    Benign Ear Neoplasm
         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
    Benign Neoplasm Of Prostate
         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
    Benign Neoplasm Of Skin
         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
    Benign Neoplasm Of Thyroid Gland
         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
    Benign Pancreatic Neoplasm
         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
    Benign Salivary Gland Neoplasm
         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
    Benign Neoplasm Of Conjunctiva
         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
    Bladder Neoplasm
         subjects affected / exposed
    17 / 9067 (0.19%)
    23 / 9077 (0.25%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 23
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Bladder Cancer Stage 0, With Cancer In Situ
         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
    Bladder Cancer Recurrent
         subjects affected / exposed
    5 / 9067 (0.06%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    32 / 9067 (0.35%)
    41 / 9077 (0.45%)
         occurrences causally related to treatment / all
    2 / 32
    2 / 41
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Biliary Neoplasm
         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
    Bile Duct Cancer
         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
    1 / 1
    0 / 0
    Benign Small Intestinal Neoplasm
         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
    Bladder Transitional Cell Carcinoma Stage Ii
         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
    Bladder Transitional Cell Carcinoma Recurrent
         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
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    3 / 9067 (0.03%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Papilloma
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Cancer
         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
    Bone Cancer Metastatic
         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 / 1
    0 / 0
    Bladder Transitional Cell Carcinoma Stage Iii
         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
    Breast Cancer
         subjects affected / exposed
    32 / 9067 (0.35%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    1 / 32
    1 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    6 / 9067 (0.07%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Brain Cancer Metastatic
         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
    Bowen's Disease
         subjects affected / exposed
    6 / 9067 (0.07%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Sarcoma
         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
    Bone Neoplasm
         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
    Bone Giant Cell Tumour
         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
    Burkitt's Lymphoma
         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
    Bronchioloalveolar Carcinoma
         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
    Bronchial Carcinoma
         subjects affected / exposed
    10 / 9067 (0.11%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Breast Neoplasm
         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
    Breast Cancer Recurrent
         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 / 1
    0 / 0
    Breast Cancer Metastatic
         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 / 2
    0 / 0
    Breast Cancer In Situ
         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
    Carcinoid Tumour
         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
    Carcinoid Tumour Pulmonary
         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
    Carcinoma In Situ
         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
    Cervix Carcinoma
         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 / 1
    0 / 0
    Central Nervous System Lymphoma
         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 Valve Fibroelastoma
         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
    Cancer 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
    Cholangiocarcinoma
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 4
         deaths causally related to treatment / all
    1 / 2
    0 / 3
    Cholesteatoma
         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
    Chondroma
         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
    Chondrosarcoma
         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
    Cervix Carcinoma Stage 0
         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
    Chronic Leukaemia
         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
    Chronic Lymphocytic Leukaemia Stage 1
         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
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    3 / 9067 (0.03%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic Myeloid Leukaemia
         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
    Colon Cancer Metastatic
         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 / 2
    0 / 1
    Colon Cancer Recurrent
         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
    Colon Cancer
         subjects affected / exposed
    32 / 9067 (0.35%)
    28 / 9077 (0.31%)
         occurrences causally related to treatment / all
    3 / 32
    2 / 28
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Chronic Myelomonocytic Leukaemia
         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
    Clear Cell Renal Cell Carcinoma
         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
    Colon Adenoma
         subjects affected / exposed
    23 / 9067 (0.25%)
    29 / 9077 (0.32%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cranial Nerve Neoplasm Benign
         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
    Colorectal Cancer Metastatic
         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
    Colorectal Adenocarcinoma
         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
    Colorectal Cancer
         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 / 0
    Colon Cancer Stage Iv
         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
    Colon Cancer Stage Iii
         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
    Colon Neoplasm
         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 / 0
    0 / 0
    Dysplastic Naevus
         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
    Ear Neoplasm
         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
    Endocrine Neoplasm Malignant
         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
    Endometrial Adenocarcinoma
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Enteropathy-Associated T-Cell Lymphoma
         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
    Essential Thrombocythaemia
         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
    Diffuse Large B-Cell Lymphoma
         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 / 1
    Gallbladder Adenocarcinoma
         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
    Fibrosarcoma
         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
    Extradural Neoplasm
         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
    Fibroma
         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
    Extramammary Paget's Disease
         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 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
    Fallopian Tube Cancer
         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
    Gastrointestinal Neoplasm
         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 Carcinoma
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric Cancer
         subjects affected / exposed
    10 / 9067 (0.11%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Gallbladder Neoplasm
         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
    Gallbladder Cancer Metastatic
         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
    Gallbladder Cancer
         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 / 2
    Gastric Neoplasm
         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 Tract Adenoma
         subjects affected / exposed
    14 / 9067 (0.15%)
    20 / 9077 (0.22%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Cancer
         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
    Glioblastoma
         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 / 2
    0 / 0
    Glioblastoma Multiforme
         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
    Glioma
         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
    Haemangioma
         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
    Gastrointestinal Stromal Tumour
         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
    Hepatic Adenoma
         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 Cancer
         subjects affected / exposed
    9 / 9067 (0.10%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    2 / 9
    1 / 7
         deaths causally related to treatment / all
    2 / 5
    1 / 3
    Hepatic Cancer Metastatic
         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 / 1
    0 / 0
    Hairy Cell Leukaemia
         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
    Haemangioma Of Bone
         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
    Haemangioma Of Liver
         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
    Haemangioma Of Spleen
         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
    Hypergammaglobulinaemia Benign Monoclonal
         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
    Huerthle Cell Carcinoma
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Neoplasm
         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
    Hodgkin's Disease
         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 / 1
    0 / 1
    Hepatocellular Carcinoma
         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 / 2
    Hypopharyngeal Cancer
         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
    Immunoblastic Lymphoma
         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
    Hepatobiliary Cancer
         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
    Intraductal Papillary-Mucinous Carcinoma Of Pancreas
         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
    Intraductal Papillary Mucinous Neoplasm
         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
    Insulinoma
         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
    Inflammatory Pseudotumour
         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
    Inflammatory Carcinoma Of The Breast
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Adenocarcinoma
         subjects affected / exposed
    4 / 9067 (0.04%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intraocular Melanoma
         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
    Invasive Ductal Breast Carcinoma
         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
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Cell Lung Cancer Stage Iii
         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
    Large Cell Lung Cancer
         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
    Keratoacanthoma
         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
    Intraductal Proliferative Breast Lesion
         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 / 1
    Leiomyosarcoma Metastatic
         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
    Leiomyoma
         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
    Leiomyosarcoma
         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 / 1
    Laryngeal Squamous Cell Carcinoma
         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
    Laryngeal Neoplasm
         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
    Laryngeal Cancer
         subjects affected / exposed
    8 / 9067 (0.09%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Large Intestine Benign Neoplasm
         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
    Leiomyosarcoma Recurrent
         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
    Lip Neoplasm Malignant Stage Unspecified
         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
    Lip And/Or Oral Cavity Cancer
         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
    Leukaemia
         subjects affected / exposed
    2 / 9067 (0.02%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    Lip Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    10 / 9067 (0.11%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liposarcoma
         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 / 1
    0 / 0
    Lentigo Maligna
         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
    Lung Carcinoma Cell Type Unspecified Stage 0
         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 / 2
    0 / 0
    Lung Carcinoma Cell Type Unspecified Recurrent
         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 / 1
    Lung Cancer Metastatic
         subjects affected / exposed
    10 / 9067 (0.11%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 7
    0 / 11
    Lung Adenocarcinoma Recurrent
         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
    Lung Adenocarcinoma Metastatic
         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 / 1
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    11 / 9067 (0.12%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 16
         deaths causally related to treatment / all
    1 / 5
    0 / 5
    Lobular Breast Carcinoma In Situ
         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
    Lymphoproliferative 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
    Lymphoma
         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 / 4
    0 / 0
    Lymphocytic Leukaemia
         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
    Lung Neoplasm Malignant
         subjects affected / exposed
    65 / 9067 (0.72%)
    66 / 9077 (0.73%)
         occurrences causally related to treatment / all
    4 / 65
    0 / 66
         deaths causally related to treatment / all
    0 / 30
    0 / 41
    Lung Neoplasm
         subjects affected / exposed
    9 / 9067 (0.10%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Lung Carcinoma Cell Type Unspecified Stage Iv
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Lung Carcinoma Cell Type Unspecified Stage I
         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
    Malignant Melanoma
         subjects affected / exposed
    28 / 9067 (0.31%)
    26 / 9077 (0.29%)
         occurrences causally related to treatment / all
    1 / 28
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma In Situ
         subjects affected / exposed
    4 / 9067 (0.04%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma Stage I
         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
    Malignant Neoplasm Of Ampulla Of Vater
         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
    Malignant Neoplasm Of Eyelid
         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
    Malignant Neoplasm Of Pleura
         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
    Malignant Ascites
         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 / 1
    0 / 0
    Mantle Cell Lymphoma Stage Iii
         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
    Medullary Thyroid Cancer
         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
    Melanocytic Naevus
         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
    Mantle Cell Lymphoma
         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
    Malignant Neoplasm Of Unknown Primary Site
         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
    Malignant Neoplasm Progression
         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
    Malignant Urinary Tract Neoplasm
         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
    Meningioma Benign
         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 Neoplasm
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         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 / 1
    0 / 2
    Mesothelioma Malignant
         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 / 1
    0 / 0
    Metastases To Adrenals
         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
    Metastases To Bone
         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 / 3
    Meningioma
         subjects affected / exposed
    8 / 9067 (0.09%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Pelvis
         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
    Metastases To Pancreas
         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
    Metastases To Lymph Nodes
         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
    Metastases To Lung
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    1 / 4
    Metastases To Liver
         subjects affected / exposed
    14 / 9067 (0.15%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 14
    2 / 9
         deaths causally related to treatment / all
    0 / 5
    2 / 4
    Metastases To Gastrointestinal Tract
         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
    Metastases To Central Nervous System
         subjects affected / exposed
    10 / 9067 (0.11%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 6
         deaths causally related to treatment / all
    0 / 4
    1 / 2
    Metastatic Gastric Cancer
         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
    Metastatic Choriocarcinoma
         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
    Metastatic Carcinoma Of The Bladder
         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 / 2
    Metastatic Carcinoid Tumour
         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
    Metastasis
         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 / 1
    0 / 5
    Metastases To The Mediastinum
         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
    Metastases To Peritoneum
         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
    Metastatic Malignant Melanoma
         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 / 3
    0 / 1
    Metastatic Neoplasm
         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 / 4
    0 / 4
    Metastatic Renal Cell Carcinoma
         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
    Mucoepidermoid Carcinoma
         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
    Monoclonal Gammopathy
         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
    Metastatic Squamous Cell Carcinoma
         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 / 1
    0 / 1
    Metastatic Lymphoma
         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
    Mycosis Fungoides Recurrent
         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
    Myelodysplastic Syndrome
         subjects affected / exposed
    4 / 9067 (0.04%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Myelofibrosis
         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
    Myeloid Leukaemia
         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
    Myeloproliferative Disorder
         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
    Nasal Sinus Cancer
         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
    Mycosis Fungoides
         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
    Natural Killer-Cell Leukaemia
         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
    Neoplasm
         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
    Neoplasm Malignant
         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 / 3
    0 / 0
    Neoplasm Prostate
         subjects affected / exposed
    3 / 9067 (0.03%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Neoplasm Skin
         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
    Neuroendocrine Carcinoma
         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
    Nasopharyngeal Cancer
         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
    Non-Hodgkin's Lymphoma Recurrent
         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
    Non-Hodgkin's Lymphoma
         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 / 1
    0 / 2
    Neuroma
         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
    Neurofibroma
         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
    Neuroendocrine Tumour
         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
    Neuroendocrine Carcinoma Metastatic
         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
    Non-Secretory Adenoma Of Pituitary
         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 Carcinoma Recurrent
         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 Carcinoma
         subjects affected / exposed
    10 / 9067 (0.11%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 8
         deaths causally related to treatment / all
    1 / 5
    0 / 3
    Oesophageal Adenocarcinoma Metastatic
         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
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    5 / 9067 (0.06%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    2 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Ocular Neoplasm
         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
    Non-Small Cell Lung Cancer Stage Iiia
         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
    Non-Small Cell Lung Cancer Metastatic
         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 / 2
    Oesophageal Adenocarcinoma
         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
    Ovarian Adenoma
         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
    Osteochondroma
         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 Squamous Cell Carcinoma
         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 / 2
    0 / 0
    Oral Neoplasm
         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
    Oligodendroglioma
         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
    Oral Neoplasm Benign
         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 Carcinoma Stage Iv
         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 / 2
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    2 / 9067 (0.02%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 6
         deaths causally related to treatment / all
    0 / 2
    2 / 5
    Pancreatic Carcinoma
         subjects affected / exposed
    17 / 9067 (0.19%)
    20 / 9077 (0.22%)
         occurrences causally related to treatment / all
    0 / 17
    2 / 20
         deaths causally related to treatment / all
    0 / 14
    1 / 15
    Ovarian Cancer
         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 / 2
    0 / 0
    Ovarian Epithelial Cancer
         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
    Ovarian Neoplasm
         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
    Ovarian Cancer Metastatic
         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 / 1
    Pharyngeal Neoplasm
         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
    Phaeochromocytoma
         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
    Pelvic Neoplasm
         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 Neoplasm
         subjects affected / exposed
    2 / 9067 (0.02%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    1 / 2
    Paraproteinaemia
         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
    Papilloma
         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
    Papillary Thyroid Cancer
         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
    Parathyroid Tumour Benign
         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
    Pleural Mesothelioma
         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
    Pleomorphic Liposarcoma
         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
    Pleomorphic Adenoma
         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
    Pituitary Tumour Benign
         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
    Plasma Cell Myeloma
         subjects affected / exposed
    6 / 9067 (0.07%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pituitary Tumour Recurrent
         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
    Plasmacytoma
         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
    Prostate Cancer Stage Ii
         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
    Prostate Cancer Recurrent
         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
    Prostate Cancer Metastatic
         subjects affected / exposed
    12 / 9067 (0.13%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Pleural Neoplasm
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prolactin-Producing Pituitary Tumour
         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
    Polycythaemia Vera
         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
    Prostate Cancer
         subjects affected / exposed
    123 / 9067 (1.36%)
    117 / 9077 (1.29%)
         occurrences causally related to treatment / all
    7 / 123
    3 / 117
         deaths causally related to treatment / all
    0 / 11
    0 / 6
    Rectal Neoplasm
         subjects affected / exposed
    2 / 9067 (0.02%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Rectal Cancer Metastatic
         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 / 1
    0 / 1
    Prostatic Adenoma
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenoma
         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
    Rectal Adenocarcinoma
         subjects affected / exposed
    3 / 9067 (0.03%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 6
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Rectal Cancer
         subjects affected / exposed
    14 / 9067 (0.15%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 11
         deaths causally related to treatment / all
    1 / 4
    0 / 2
    Renal Neoplasm
         subjects affected / exposed
    5 / 9067 (0.06%)
    19 / 9077 (0.21%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    10 / 9067 (0.11%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Cancer Recurrent
         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
    Rectosigmoid Cancer
         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
    Renal Cancer
         subjects affected / exposed
    9 / 9067 (0.10%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal Adenoma
         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
    Renal Cancer Metastatic
         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 / 1
    0 / 0
    Schwannoma
         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
    Sarcomatoid Mesothelioma
         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
    Sarcoma
         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
    Renal Oncocytoma
         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
    Salivary Gland Cancer
         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
    Salivary Gland Adenoma
         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
    Salivary Gland Neoplasm
         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
    Small Cell Lung Cancer Metastatic
         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 / 2
    0 / 4
    Small Cell Lung Cancer
         subjects affected / exposed
    12 / 9067 (0.13%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 9
    0 / 5
    Small Cell Carcinoma
         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 / 3
    0 / 1
    Seborrhoeic Keratosis
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Cancer Metastatic
         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
    Skin Cancer
         subjects affected / exposed
    18 / 9067 (0.20%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 18
    1 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminoma
         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
    Skin Papilloma
         subjects affected / exposed
    2 / 9067 (0.02%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of The Oral Cavity
         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
    Squamous Cell Carcinoma Of Skin
         subjects affected / exposed
    13 / 9067 (0.14%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of Lung
         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 / 6
    0 / 1
    Small Intestine Carcinoma
         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
    Squamous Cell Carcinoma
         subjects affected / exposed
    84 / 9067 (0.93%)
    91 / 9077 (1.00%)
         occurrences causally related to treatment / all
    1 / 84
    4 / 91
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Spindle Cell Sarcoma
         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
    Squamous Cell Carcinoma Of Head And Neck
         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
    Thymoma Malignant
         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
    Throat Cancer
         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
    Squamous Cell Carcinoma Of The Tongue
         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
    T-Cell Lymphoma
         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 / 1
    1 / 1
    Sweat Gland Tumour
         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
    Testis Cancer
         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
    Tongue Neoplasm Malignant Stage Unspecified
         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
    Tongue Cancer Metastatic
         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
    Thyroid Neoplasm
         subjects affected / exposed
    5 / 9067 (0.06%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma Malignant Recurrent
         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
    Thyroid Cancer
         subjects affected / exposed
    5 / 9067 (0.06%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Adenoma
         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
    Thyroid Cancer Metastatic
         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
    Transitional Cell Carcinoma
         subjects affected / exposed
    15 / 9067 (0.17%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    1 / 15
    3 / 8
         deaths causally related to treatment / all
    0 / 3
    1 / 1
    Tracheal Neoplasm
         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
    Ureteric Cancer Recurrent
         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
    Ureteric Cancer
         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
    Tracheal Cancer
         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
    Ureteral Neoplasm
         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
    Urethral Cancer
         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
    Tumour 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
    Uterine Leiomyoma
         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
    Uterine Cancer
         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
    Urinary Tract Neoplasm
         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
    Urinary Bladder Sarcoma
         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 Adenoma
         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 disorders
    Aneurysm
         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
    Accelerated Hypertension
         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
    Aortic 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
    Aortic Dilatation
         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
    Aortic Aneurysm Rupture
         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 / 2
    0 / 0
    Angiopathy
         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 Aneurysm
         subjects affected / exposed
    29 / 9067 (0.32%)
    40 / 9077 (0.44%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 40
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Angiodysplasia
         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
    Arterial Occlusive 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
    Arterial 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
    Aortic Stenosis
         subjects affected / exposed
    9 / 9067 (0.10%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic 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
    Aortic Dissection
         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 / 1
    0 / 0
    Behcet's 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
    Blood Pressure Fluctuation
         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 Inadequately Controlled
         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
    Arterial Thrombosis
         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
    Arteriosclerosis
         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
    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
    Essential Hypertension
         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
    Extremity Necrosis
         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
    Arteriovenous Fistula
         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
    Deep Vein Thrombosis
         subjects affected / exposed
    19 / 9067 (0.21%)
    33 / 9077 (0.36%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Emergency
         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
    Hypertensive Crisis
         subjects affected / exposed
    21 / 9067 (0.23%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    25 / 9067 (0.28%)
    27 / 9077 (0.30%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         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
    Haematoma
         subjects affected / exposed
    12 / 9067 (0.13%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis With Polyangiitis
         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
    Femoral Artery Occlusion
         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
    Hypotension
         subjects affected / exposed
    27 / 9067 (0.30%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Hot Flush
         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
    Femoral Artery Aneurysm
         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
    Lymphatic Fistula
         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
    Leriche 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
    Jugular Vein Thrombosis
         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
    Ischaemia
         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 / 1
    0 / 0
    Lymphoedema
         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
    Intermittent Claudication
         subjects affected / exposed
    6 / 9067 (0.07%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac 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
    Hypovolaemic Shock
         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 / 2
    0 / 1
    Lymphocele
         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
    Intra-Abdominal 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
    Necrosis Ischaemic
         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
    Neurogenic Shock
         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
    Orthostatic Hypotension
         subjects affected / exposed
    10 / 9067 (0.11%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Aneurysm
         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
    Peripheral Arterial Occlusive Disease
         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
    Peripheral Artery 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
    Peripheral Artery Thrombosis
         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
    Peripheral Embolism
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         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
    Peripheral Vascular Disorder
         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
    Malignant Hypertension
         subjects affected / exposed
    0 / 9067 (0.00%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Thrombotic Syndrome
         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
    Phlebitis
         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
    Subclavian Artery 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
    Superior Vena Cava 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
    Superior Vena Cava 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
    Thrombophlebitis
         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
    Temporal Arteritis
         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
    Thrombophlebitis Superficial
         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
    Thrombosis
         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
    Shock Haemorrhagic
         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
    Varicose Vein
         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
    Vascular 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
    Vasculitis
         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
    Vasculitis 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
    Venous Insufficiency
         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
    Venous 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
    Venous Thrombosis Limb
         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 / 1
    Varicose Ulceration
         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
    Surgical and medical procedures
    Appendicectomy
         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
    Arthrodesis
         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
    Finger Amputation
         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
    Fascia Release
         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
    Colostomy
         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
    Cataract Operation
         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 Rehabilitation Therapy
         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
    Cholecystectomy
         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
    Bladder Catheterisation
         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 Pacemaker Replacement
         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
    Gastrectomy
         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
    Colectomy
         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
    Implantable Defibrillator Insertion
         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
    Immunoglobulin Therapy
         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
    Ileostomy
         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
    Hip Surgery
         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
    Hip Arthroplasty
         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
    Hernia Repair
         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
    Gastrointestinal Surgery
         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 Bypass
         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
    Hospitalisation
         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
    Intraocular Lens Implant
         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 Arthroplasty
         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
    Mammoplasty
         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
    Knee Operation
         subjects affected / exposed
    13 / 9067 (0.14%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional Hernia Repair
         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
    Knee Arthroplasty
         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
    Nasal Septal Operation
         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
    Nasal Polypectomy
         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
    Mitral Valve Repair
         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
    Penile Prosthesis Insertion
         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
    Preoperative Care
         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
    Prophylaxis
         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
    Prostatectomy
         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
    Rehabilitation Therapy
         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
    Percutaneous Coronary Intervention
         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
    Shoulder Arthroplasty
         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
    Shoulder Operation
         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 Decompression
         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
    Surgery
         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
    Rotator Cuff Repair
         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
    Thyroidectomy
         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 Removal
         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
    Tooth Extraction
         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
    Transurethral Bladder Resection
         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
    Transurethral Prostatectomy
         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
    Turbinectomy
         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
    Varicose Vein Operation
         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
    Vertebroplasty
         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
    General disorders and administration site conditions
    Adverse Drug 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
    Brca2 Gene Mutation
         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
    Adverse Event
         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
    Adverse Reaction
         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
    Asthenia
         subjects affected / exposed
    14 / 9067 (0.15%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheter Site 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
    Chest Discomfort
         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
    Device Battery Issue
         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
    Cyst 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
    Chills
         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
    Cyst
         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
    Complication Of Device Insertion
         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
    Device Breakage
         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
    Chest Pain
         subjects affected / exposed
    7 / 9067 (0.08%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Failure
         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
    Device Issue
         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
    Device Lead Damage
         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
    Device Lead Issue
         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
    Device Malfunction
         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
    Device Dislocation
         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
    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
    Device 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
    Feeling Cold
         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
    Fatigue
         subjects affected / exposed
    9 / 9067 (0.10%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fat Necrosis
         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
    Drug Withdrawal 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
    Gait Disturbance
         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
    Fibrosis
         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
    Generalised Oedema
         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
    Granuloma
         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
    Feeling Hot
         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
    General Physical Health Deterioration
         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
    Implant Site Extravasation
         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
    Impaired Healing
         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
    Hypothermia
         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
    Hyperplasia
         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
    Hernia Obstructive
         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
    Hernia
         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
    Malaise
         subjects affected / exposed
    8 / 9067 (0.09%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Local Swelling
         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
    Influenza Like Illness
         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
    Inflammation
         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
    Implant 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
    Injection Site 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
    Metaplasia
         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
    Necrosis
         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
    Multi-Organ Failure
         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 / 1
    0 / 0
    Mucosal Inflammation
         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
    Medical Device Complication
         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
    Pacemaker 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
    Pain
         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
    Pelvic 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 / 1
    0 / 0
    Pacemaker Generated Arrhythmia
         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
    Non-Cardiac Chest Pain
         subjects affected / exposed
    14 / 9067 (0.15%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         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
    Polyp
         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
    Pyrexia
         subjects affected / exposed
    24 / 9067 (0.26%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Stent-Graft Endoleak
         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
    Submandibular 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
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    0 / 9067 (0.00%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Puncture Site 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 / 0
    Ulcer
         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
    Ulcer 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
    Xerosis
         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
    Thrombosis In Device
         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
    Immune system disorders
    Allergy To 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
    Anaphylactic Reaction
         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
    Anaphylactic Shock
         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
    Autoimmune 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
    Drug Hypersensitivity
         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
    Hypersensitivity
         subjects affected / exposed
    8 / 9067 (0.09%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    3 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seasonal Allergy
         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
    Social circumstances
    Cardiac Assistance Device User
         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
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    72 / 9067 (0.79%)
    72 / 9077 (0.79%)
         occurrences causally related to treatment / all
    0 / 72
    0 / 72
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast 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
    Erectile Dysfunction
         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
    Endometrial Hypertrophy
         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
    Endometrial Hyperplasia
         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
    Breast Mass
         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
    Cervical Polyp
         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
    Cervical Dysplasia
         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
    Cystocele
         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
    Pelvic 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
    Ovarian 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
    Ovarian Cyst
         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
    Female Genital Tract Fistula
         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
    Gynaecomastia
         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
    Fibrocystic Breast 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
    Menorrhagia
         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
    Pelvic Prolapse
         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
    Penis Disorder
         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
    Penile Vein Thrombosis
         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
    Peyronie's 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
    Postmenopausal Haemorrhage
         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
    Prostatic 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
    Prostatic 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
    Prostatism
         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
    Prostatic Dysplasia
         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
    Prostatic Obstruction
         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
    Prostatitis
         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 / 0
    0 / 0
    Prostatomegaly
         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
    Rectoprostatic Fistula
         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 Haematocoele
         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
    Vaginal 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
    Uterine Prolapse
         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
    Uterine Polyp
         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
    Vaginal 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
    Uterovaginal Prolapse
         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
    Spermatocele
         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
    Uterine 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
    Vaginal Prolapse
         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
    Vaginal Hyperplasia
         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
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    6 / 9067 (0.07%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute Respiratory Distress Syndrome
         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 / 1
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    18 / 9067 (0.20%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Asphyxia
         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
    Asthma
         subjects affected / exposed
    13 / 9067 (0.14%)
    17 / 9077 (0.19%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atelectasis
         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
    Bronchial Hyperreactivity
         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
    Bronchial Obstruction
         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
    Bronchiectasis
         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
    Bronchopneumopathy
         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
    Bronchopulmonary 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
    Bronchial 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
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    109 / 9067 (1.20%)
    105 / 9077 (1.16%)
         occurrences causally related to treatment / all
    1 / 109
    0 / 105
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Bronchospasm
         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
    Chronic Respiratory Disease
         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
    Cough
         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
    Dyspnoea
         subjects affected / exposed
    47 / 9067 (0.52%)
    56 / 9077 (0.62%)
         occurrences causally related to treatment / all
    1 / 47
    0 / 56
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Dyspnoea Exertional
         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 / 0
    Dyspnoea Paroxysmal Nocturnal
         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
    Emphysema
         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
    Epistaxis
         subjects affected / exposed
    23 / 9067 (0.25%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 23
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    10 / 9067 (0.11%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemothorax
         subjects affected / exposed
    0 / 9067 (0.00%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         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
    Hypoxia
         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
    Idiopathic Pulmonary Fibrosis
         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
    Interstitial Lung 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
    Laryngeal 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
    Laryngeal Oedema
         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
    Laryngeal Polyp
         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
    Laryngeal Ulceration
         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
    Laryngeal 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
    Laryngospasm
         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
    Lung Disorder
         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
    Lung 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
    Lung Infiltration
         subjects affected / exposed
    1 / 9067 (0.01%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal 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
    Nasal Polyps
         subjects affected / exposed
    6 / 9067 (0.07%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Turbinate Hypertrophy
         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
    Nasal Septum 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
    Nasal Septum Deviation
         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
    Oropharyngeal 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
    Organising Pneumonia
         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
    Obstructive Airways 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
    Orthopnoea
         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
    Pickwickian 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
    Pleural Effusion
         subjects affected / exposed
    24 / 9067 (0.26%)
    24 / 9077 (0.26%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleural Fibrosis
         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
    Pleurisy
         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
    Pneumothorax Spontaneous
         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
    Pneumonia Aspiration
         subjects affected / exposed
    8 / 9067 (0.09%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pulmonary Arterial Hypertension
         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
    Pleuritic Pain
         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
    Pneumothorax
         subjects affected / exposed
    14 / 9067 (0.15%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         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
    Pulmonary Embolism
         subjects affected / exposed
    46 / 9067 (0.51%)
    36 / 9077 (0.40%)
         occurrences causally related to treatment / all
    0 / 46
    0 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Pulmonary Fibrosis
         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 / 1
    0 / 2
    Pulmonary Hypertension
         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
    Pulmonary Granuloma
         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
    Pulmonary Haemorrhage
         subjects affected / exposed
    2 / 9067 (0.02%)
    0 / 9077 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Arrest
         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 / 3
    0 / 1
    Respiratory Acidosis
         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
    Respiratory Distress
         subjects affected / exposed
    6 / 9067 (0.07%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory 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
    Pulmonary Oedema
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    19 / 9067 (0.21%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 22
         deaths causally related to treatment / all
    0 / 2
    1 / 1
    Respiratory Failure
         subjects affected / exposed
    32 / 9067 (0.35%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 22
         deaths causally related to treatment / all
    0 / 9
    0 / 7
    Restrictive Pulmonary 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
    Sleep Apnoea Syndrome
         subjects affected / exposed
    12 / 9067 (0.13%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal Stenosis
         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
    Status Asthmaticus
         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
    Tracheomalacia
         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
    Vocal Cord Leukoplakia
         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
    Vocal Cord Inflammation
         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
    Vocal Cord 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
    Upper Respiratory Tract 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
    Vocal Cord Polyp
         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
    Psychiatric disorders
    Acute Psychosis
         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
    Abnormal Behaviour
         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
    Bipolar I 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
    Bipolar Disorder
         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
    Anxiety Disorder
         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
    Alcohol Withdrawal Syndrome
         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
    Alcoholism
         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
    Anxiety
         subjects affected / exposed
    12 / 9067 (0.13%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Abuse
         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
    Delirium Tremens
         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
    Delirium
         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
    Conversion 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
    Confusional State
         subjects affected / exposed
    9 / 9067 (0.10%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         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 / 2
    Burnout 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
    Bipolar Ii 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
    Hypomania
         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
    Insomnia
         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
    Major Depression
         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
    Hallucination
         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
    Depression
         subjects affected / exposed
    19 / 9067 (0.21%)
    17 / 9077 (0.19%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Disorientation
         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 / 1
    Generalised Anxiety 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
    Post-Traumatic Stress Disorder
         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
    Paranoia
         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
    Panic Attack
         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
    Neurosis
         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
    Mental Status Changes
         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 / 1
    Mental Disorder Due To A General Medical Condition
         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
    Mental 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
    Somatisation 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
    Somatoform 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
    Stress
         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
    Sleep 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
    Schizophrenia, Paranoid Type
         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
    Schizophrenia
         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
    Psychotic Disorder
         subjects affected / exposed
    2 / 9067 (0.02%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Withdrawal 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
    Suicide Attempt
         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
    Suicidal Ideation
         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
    Hepatobiliary disorders
    Alcoholic Liver Disease
         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
    Bile Duct Obstruction
         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
    Bile Duct Stenosis
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         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
    Cholangitis
         subjects affected / exposed
    4 / 9067 (0.04%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Tract Disorder
         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
    Biliary Dyskinesia
         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
    Biliary Colic
         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
    Bile Duct Stone
         subjects affected / exposed
    7 / 9067 (0.08%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis Alcoholic
         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
    Cholestasis
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cholelithiasis
         subjects affected / exposed
    78 / 9067 (0.86%)
    71 / 9077 (0.78%)
         occurrences causally related to treatment / all
    3 / 78
    6 / 71
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    3 / 9067 (0.03%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    27 / 9067 (0.30%)
    26 / 9077 (0.29%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    47 / 9067 (0.52%)
    73 / 9077 (0.80%)
         occurrences causally related to treatment / all
    3 / 47
    10 / 73
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallbladder Cholesterolosis
         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
    Gallbladder Disorder
         subjects affected / exposed
    5 / 9067 (0.06%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder 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
    Gallbladder 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
    Gallbladder Polyp
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-Induced Liver Injury
         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
    Granulomatous Liver 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
    Hepatic Steatosis
         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 Cirrhosis
         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
    Hepatic Cyst
         subjects affected / exposed
    6 / 9067 (0.07%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         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 / 2
    0 / 0
    Hepatic Mass
         subjects affected / exposed
    2 / 9067 (0.02%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    3 / 9067 (0.03%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal Syndrome
         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 / 1
    0 / 1
    Hydrocholecystis
         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
    Hyperbilirubinaemia
         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 Hepatitis
         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
    Jaundice
         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
    Jaundice Cholestatic
         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
    Liver 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
    Portal Hypertension
         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
    Portal Vein 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
    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
    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
    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
    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 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
    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
    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
    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 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
    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
    Injury, poisoning and procedural complications
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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 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
    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
    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
    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 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
    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
    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
    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
    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
    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
    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
    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
    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 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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
         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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    Ear and labyrinth disorders
    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 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
         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
    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
    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 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 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
         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
    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
    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
    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
    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
    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
    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
    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
    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
    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 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
    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
    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 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
    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
    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
    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
    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
    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
    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 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
    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
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         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
    Parotid Gland Enlargement
         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 Relapsing
         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 / 1
    0 / 0
    Peritoneal 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
    Rectal Polyp
         subjects affected / exposed
    17 / 9067 (0.19%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal 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
    Rectal Haemorrhage
         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 / 1
    0 / 0
    Proctalgia
         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
    Pneumoperitoneum
         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
    Pneumatosis Intestinalis
         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
    Rectal Ulcer 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
    Rectourethral Fistula
         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
    Reflux Gastritis
         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 Haematoma
         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
    Retroperitoneal Haemorrhage
         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
    Rectal Prolapse
         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
    Tongue Dysplasia
         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
    Subileus
         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
    Splenic Artery Aneurysm
         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
    Small Intestinal Obstruction
         subjects affected / exposed
    13 / 9067 (0.14%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Small Intestinal 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
    Salivary Gland Calculus
         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
    Vomiting
         subjects affected / exposed
    8 / 9067 (0.09%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         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
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    26 / 9067 (0.29%)
    25 / 9077 (0.28%)
         occurrences causally related to treatment / all
    0 / 26
    1 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Umbilical 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
    Umbilical Hernia
         subjects affected / exposed
    6 / 9067 (0.07%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    3 / 9067 (0.03%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Actinic Keratosis
         subjects affected / exposed
    12 / 9067 (0.13%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    9 / 9067 (0.10%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatomyositis
         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
    Dermatitis Allergic
         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
    Dermatitis
         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
    Dermal Cyst
         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
    Decubitus Ulcer
         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
    Campbell De Morgan Spots
         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 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
    Eczema
         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
    Ecchymosis
         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
    Drug Eruption
         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
    Erythema
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Excessive Granulation Tissue
         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
    Hyperkeratosis
         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
    Granuloma Skin
         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
    Hypersensitivity Vasculitis
         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
    Lichen Planus
         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
    Night Sweats
         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
    Macule
         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
    Palmoplantar Keratoderma
         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
    Lichenoid Keratosis
         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
    Precancerous Skin Lesion
         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
    Pityriasis
         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
    Pemphigoid
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Punctate Keratosis
         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
    Rash
         subjects affected / exposed
    3 / 9067 (0.03%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    1 / 3
    5 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Generalised
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Papular
         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
    Rash Pruritic
         subjects affected / exposed
    0 / 9067 (0.00%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Lesion
         subjects affected / exposed
    3 / 9067 (0.03%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin 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
    Skin Burning Sensation
         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
    Skin 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
    Skin Ulcer
         subjects affected / exposed
    8 / 9067 (0.09%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Solar Lentigo
         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
    Subcutaneous Emphysema
         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
    Swelling Face
         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 Skin Eruption
         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
    Urticaria
         subjects affected / exposed
    1 / 9067 (0.01%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder Mass
         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
    Bladder Diverticulum
         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
    Azotaemia
         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
    Acute Prerenal Failure
         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
    Bladder Tamponade
         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
    Bladder Spasm
         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
    Bladder Prolapse
         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
    Bladder Neck 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
    Bladder 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
    Bladder Neck Sclerosis
         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
    Bladder 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
    Cystitis Noninfective
         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
    Cystitis 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
    Crush 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
    Calculus Bladder
         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
    Calculus Urethral
         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
    Calculus Ureteric
         subjects affected / exposed
    16 / 9067 (0.18%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         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
    Hypotonic Urinary Bladder
         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
    Hypertonic Bladder
         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
    Hydronephrosis
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Nephropathy
         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 / 2
    Glomerulonephritis
         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
    Dysuria
         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
    Haematuria
         subjects affected / exposed
    27 / 9067 (0.30%)
    20 / 9077 (0.22%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal 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
    Pyelocaliectasis
         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
    Obstructive Uropathy
         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
    Lower Urinary Tract Symptoms
         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
    Nephrosclerosis
         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
    Nephropathy
         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
    Nephrolithiasis
         subjects affected / exposed
    31 / 9067 (0.34%)
    35 / 9077 (0.39%)
         occurrences causally related to treatment / all
    1 / 31
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic 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
    Renal Failure
         subjects affected / exposed
    38 / 9067 (0.42%)
    29 / 9077 (0.32%)
         occurrences causally related to treatment / all
    1 / 38
    1 / 29
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    Renal 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
    Renal 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
    Renal Artery Stenosis
         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
    Renal Cyst
         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
    Renal Colic
         subjects affected / exposed
    7 / 9067 (0.08%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cyst Ruptured
         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
    Renal Infarct
         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
    Renal Impairment
         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
    Renal Failure Acute
         subjects affected / exposed
    51 / 9067 (0.56%)
    61 / 9077 (0.67%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 61
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Renal 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
    Renal Failure Chronic
         subjects affected / exposed
    12 / 9067 (0.13%)
    6 / 9077 (0.07%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Hypertension
         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
    Ureteric Obstruction
         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
    Ureteric Dilatation
         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
    Tubulointerstitial Nephritis
         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
    Renal 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
    Renal Tubular Necrosis
         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 / 1
    0 / 0
    Renal Mass
         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
    Stress Urinary Incontinence
         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
    Urinary Bladder 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
    Urge Incontinence
         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
    Urethral Stenosis
         subjects affected / exposed
    9 / 9067 (0.10%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric 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
    Urethral Dilatation
         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
    Urethral Caruncle
         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
    Urethral 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
    Urinary Tract 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
    Urinary Tract 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
    Urinary Retention
         subjects affected / exposed
    14 / 9067 (0.15%)
    27 / 9077 (0.30%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Polyp
         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
    Urinary Incontinence
         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
    Endocrine disorders
    Adrenal Insufficiency
         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
    Adrenal Mass
         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
    Basedow's Disease
         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
    Goitre
         subjects affected / exposed
    5 / 9067 (0.06%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate Antidiuretic Hormone Secretion
         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
    Hypothyroidism
         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
    Pituitary 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
    Hyperparathyroidism Primary
         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
    Hyperparathyroidism
         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
    Hyperthyroidism
         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
    Thyroid 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
    Thyroid 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
    Postpartum Hypopituitarism
         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
    Thyroid 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
    Toxic Nodular Goitre
         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
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    32 / 9067 (0.35%)
    23 / 9077 (0.25%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    25 / 9067 (0.28%)
    23 / 9077 (0.25%)
         occurrences causally related to treatment / all
    0 / 25
    3 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         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
    Bone Pain
         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
    Bone Lesion
         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
    Arthritis Reactive
         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
    Arthropathy
         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
    Arthrofibrosis
         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
    Back Pain
         subjects affected / exposed
    36 / 9067 (0.40%)
    34 / 9077 (0.37%)
         occurrences causally related to treatment / all
    0 / 36
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diastasis Recti Abdominis
         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
    Costochondritis
         subjects affected / exposed
    2 / 9067 (0.02%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment Syndrome
         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
    Cervical Spinal Stenosis
         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
    Chest Wall Mass
         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
    Chest Wall Cyst
         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
    Chondropathy
         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
    Flank Pain
         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
    Fistula
         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
    Fibromyalgia
         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
    Dupuytren's Contracture
         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
    Exostosis
         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
    Epiphysitis
         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
    Extraskeletal Ossification
         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
    Groin Pain
         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
    Gouty Arthritis
         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
    Foot Deformity
         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
    Fracture Malunion
         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
    Fracture Nonunion
         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
    Joint Effusion
         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
    Intervertebral Disc Protrusion
         subjects affected / exposed
    28 / 9067 (0.31%)
    35 / 9077 (0.39%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Displacement
         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
    Haemarthrosis
         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
    Intervertebral Disc Degeneration
         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 / 0
    Intervertebral Disc Compression
         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
    Metatarsalgia
         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
    Intervertebral Disc Disorder
         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 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    19 / 9067 (0.21%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Extremity Mass
         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
    Joint Instability
         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
    Knee Deformity
         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
    Limb Discomfort
         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
    Joint Swelling
         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
    Musculoskeletal Discomfort
         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
    Musculoskeletal Chest Pain
         subjects affected / exposed
    34 / 9067 (0.37%)
    21 / 9077 (0.23%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    3 / 9067 (0.03%)
    1 / 9077 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility Decreased
         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
    Muscle Disorder
         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
    Morphoea
         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
    Monarthritis
         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
    Muscle Spasms
         subjects affected / exposed
    0 / 9067 (0.00%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    20 / 9067 (0.22%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    15 / 20
    10 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    14 / 9067 (0.15%)
    13 / 9077 (0.14%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Mass
         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
    Myositis
         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
    Myopathy
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    4 / 6
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myofascial Pain 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
    Myalgia Intercostal
         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
    Osteonecrosis
         subjects affected / exposed
    2 / 9067 (0.02%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    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
    Osteochondrosis
         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
    Osteoarthritis
         subjects affected / exposed
    175 / 9067 (1.93%)
    159 / 9077 (1.75%)
         occurrences causally related to treatment / all
    0 / 175
    0 / 159
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         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
    Neck Pain
         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
    Neuropathic Arthropathy
         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
    Polymyositis
         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
    Polymyalgia Rheumatica
         subjects affected / exposed
    1 / 9067 (0.01%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         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
    Periarthritis
         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
    Pain In Jaw
         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
    Pain In Extremity
         subjects affected / exposed
    10 / 9067 (0.11%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         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
    Rhabdomyolysis
         subjects affected / exposed
    12 / 9067 (0.13%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    10 / 12
    17 / 18
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Rheumatic Fever
         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
    Rheumatoid Arthritis
         subjects affected / exposed
    3 / 9067 (0.03%)
    8 / 9077 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Deformity
         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
    Rotator Cuff Syndrome
         subjects affected / exposed
    21 / 9067 (0.23%)
    16 / 9077 (0.18%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma
         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
    Psoriatic Arthropathy
         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 Stenosis
         subjects affected / exposed
    22 / 9067 (0.24%)
    27 / 9077 (0.30%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Disorder
         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
    Spinal Osteoarthritis
         subjects affected / exposed
    12 / 9067 (0.13%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         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
    Spondylitis
         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
    Spondylolisthesis
         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
    Soft Tissue Disorder
         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
    Synovitis
         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
    Systemic Lupus Erythematosus
         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
    Synovial 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
    Synovial Cyst
         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
    Tendon Disorder
         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
    Tendonitis
         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
    Tenosynovitis
         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
    Vertebral Foraminal Stenosis
         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
    Upper Extremity 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
    Torticollis
         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
    Infections and infestations
    Abscess Intestinal
         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
    Abscess
         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
    Abdominal Wall Infection
         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 Abscess
         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 Sepsis
         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 / 1
    0 / 0
    Abdominal Abscess
         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
    Abscess Neck
         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
    Abscess Limb
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Jaw
         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
    Alpha Haemolytic Streptococcal Infection
         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
    Acute Sinusitis
         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
    Abscess Oral
         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
    Arthritis Bacterial
         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
    Anal Abscess
         subjects affected / exposed
    11 / 9067 (0.12%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    7 / 9067 (0.08%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    33 / 9067 (0.36%)
    18 / 9077 (0.20%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Infective
         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
    Appendiceal Abscess
         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
    Blister Infected
         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
    Bacterial Sepsis
         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
    Bacterial Infection
         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
    Bacteraemia
         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 / 1
    Biliary Sepsis
         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
    Breast Abscess
         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
    Bronchiolitis
         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
    Bronchitis
         subjects affected / exposed
    49 / 9067 (0.54%)
    43 / 9077 (0.47%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Bacterial
         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
    Brain Abscess
         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
    Bronchitis Viral
         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
    Campylobacter Infection
         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
    Bronchopneumonia
         subjects affected / exposed
    17 / 9067 (0.19%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 14
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Campylobacter Gastroenteritis
         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
    Cellulitis
         subjects affected / exposed
    49 / 9067 (0.54%)
    63 / 9077 (0.69%)
         occurrences causally related to treatment / all
    0 / 49
    0 / 63
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Cardiac Infection
         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
    Chronic Sinusitis
         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
    Cholecystitis Infective
         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
    Cellulitis Of Male External Genital Organ
         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
    Candida Infection
         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
    Cystitis
         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
    Coccidioidomycosis
         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
    Colonic Abscess
         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
    Clostridium Difficile Sepsis
         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
    Clostridium Difficile Colitis
         subjects affected / exposed
    12 / 9067 (0.13%)
    4 / 9077 (0.04%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Clostridium Difficile Infection
         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
    Device Related Infection
         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
    Diabetic Foot Infection
         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
    Diarrhoea Infectious
         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
    Diabetic Gangrene
         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
    Diverticulitis
         subjects affected / exposed
    34 / 9067 (0.37%)
    37 / 9077 (0.41%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         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 / 0
    0 / 0
    Echinococciasis
         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 Infection
         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
    Empyema
         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
    Encephalitis Viral
         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
    Endocarditis Bacterial
         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
    Endocarditis Enterococcal
         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
    Encephalitis
         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
    Endocarditis
         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 / 1
    0 / 0
    Emphysematous Cholecystitis
         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
    Escherichia Bacteraemia
         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
    Erysipelas
         subjects affected / exposed
    18 / 9067 (0.20%)
    14 / 9077 (0.15%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         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 / 0
    0 / 0
    Epidemic Nephropathy
         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
    Endophthalmitis
         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
    Epiglottitis
         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
    Extradural Abscess
         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
    Folliculitis
         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
    Febrile Infection
         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
    Gangrene
         subjects affected / exposed
    3 / 9067 (0.03%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Empyema
         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
         subjects affected / exposed
    51 / 9067 (0.56%)
    44 / 9077 (0.48%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 44
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fungal Skin Infection
         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
    Fungal Infection
         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
    Furuncle
         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 Bacterial
         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 Rotavirus
         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
    Gastroenteritis Salmonella
         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
    Gastroenteritis Viral
         subjects affected / exposed
    5 / 9067 (0.06%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Candidiasis
         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 Infection
         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 / 1
    0 / 0
    Gastroenteritis Norovirus
         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
    Hand-Foot-And-Mouth Disease
         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
    H1n1 Influenza
         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
    Gingival Abscess
         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
    Groin Infection
         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
    Groin Abscess
         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
    Helicobacter Gastritis
         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
    Graft Infection
         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
    Implant Site Infection
         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
    Hiv Infection
         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
    Herpes Simplex Encephalitis
         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
    Hepatitis C
         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
    Hepatitis B
         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
    Herpes Zoster
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision Site Infection
         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
    Infected Bites
         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 Gangrenous
         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
    Infected Cyst
         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
    Infected Dermal Cyst
         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
    Infected Skin 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
    Incision Site Cellulitis
         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
    Influenza
         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
    Intervertebral Discitis
         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
    Infection
         subjects affected / exposed
    12 / 9067 (0.13%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infectious Pleural 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
    Infectious Colitis
         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
    Infective Exacerbation Of Chronic Obstructive Airways Disease
         subjects affected / exposed
    7 / 9067 (0.08%)
    2 / 9077 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Abscess
         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
    Kidney Infection
         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
    Lobar Pneumonia
         subjects affected / exposed
    16 / 9067 (0.18%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         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
    Laryngitis
         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
    Labyrinthitis
         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
    Klebsiella Sepsis
         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
    Lyme Disease
         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
    Lung Infection
         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
    Localised Infection
         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
    Lower Respiratory Tract Infection Viral
         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 Respiratory Tract Infection
         subjects affected / exposed
    10 / 9067 (0.11%)
    11 / 9077 (0.12%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         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
    Meningitis Viral
         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
    Meningitis Aseptic
         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
    Lymph Node Tuberculosis
         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
    Mediastinitis
         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
    Mastoiditis
         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
    Meningitis
         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
    Orchitis
         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
    Oesophageal Candidiasis
         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
    Myelitis
         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
    Nasopharyngitis
         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
    Myringitis
         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
    Necrotising Fasciitis
         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
    Perineal Abscess
         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
    Parotitis
         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
    Pancreas Infection
         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
    Osteomyelitis
         subjects affected / exposed
    4 / 9067 (0.04%)
    10 / 9077 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         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
    Osteomyelitis Chronic
         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
    Otitis Media 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
    Periumbilical Abscess
         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
    Peritonsillar Abscess
         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
    Periodontitis
         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
    Peritonitis
         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 / 2
    0 / 2
    Perirectal Abscess
         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
    Peritonitis Bacterial
         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
    Pneumonia Influenzal
         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
    Pneumonia Chlamydial
         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
    Pneumonia Bacterial
         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 / 1
    0 / 0
    Pharyngitis
         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
    Pneumococcal Sepsis
         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
    Pilonidal 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
    Pneumonia
         subjects affected / exposed
    255 / 9067 (2.81%)
    242 / 9077 (2.67%)
         occurrences causally related to treatment / all
    0 / 255
    1 / 242
         deaths causally related to treatment / all
    0 / 17
    0 / 12
    Post Procedural Infection
         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
    Pneumonia Viral
         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
    Pneumonia Legionella
         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
    Pneumonia Pseudomonal
         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
    Pneumonia Pneumococcal
         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
    Pneumonia Streptococcal
         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
    Pseudomonas Infection
         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
    Pseudomembranous Colitis
         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 Abscess
         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
    Proctitis Infectious
         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 Wound Infection
         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 / 0
    Prostate Infection
         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
    Q Fever
         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
    Pyomyositis
         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
    Pyelonephritis Acute
         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
    Psoas Abscess
         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 Tuberculosis
         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
    Pulmonary Sepsis
         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 / 1
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    15 / 9067 (0.17%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    10 / 9067 (0.11%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Abscess
         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
    Rectal Abscess
         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
    Respiratory Tract Infection Viral
         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
    Rotavirus Infection
         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
    Rhinitis
         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
    Scrotal Abscess
         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
    Shunt Infection
         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
    Serratia Infection
         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
    Sepsis
         subjects affected / exposed
    37 / 9067 (0.41%)
    33 / 9077 (0.36%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 33
         deaths causally related to treatment / all
    0 / 7
    0 / 8
    Septic 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
    Sepsis Syndrome
         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
    Septic Shock
         subjects affected / exposed
    12 / 9067 (0.13%)
    12 / 9077 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Staphylococcal Infection
         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 / 1
    Staphylococcal Bacteraemia
         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
    Sinusitis
         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
    Soft Tissue Infection
         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
    Skin Infection
         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
    Staphylococcal Abscess
         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
    Tick-Borne Fever
         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
    Sweat Gland Infection
         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
    Subcutaneous Abscess
         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
    Staphylococcal Sepsis
         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 / 1
    Streptococcal Infection
         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
    Sternitis
         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
    Subacute Endocarditis
         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
    Upper Respiratory Tract Infection
         subjects affected / exposed
    15 / 9067 (0.17%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         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
    Tooth Abscess
         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
    Tonsillitis
         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
    Tracheobronchitis
         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
    Urinary Tract Infection
         subjects affected / exposed
    77 / 9067 (0.85%)
    79 / 9077 (0.87%)
         occurrences causally related to treatment / all
    0 / 77
    0 / 79
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Tuberculosis
         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
    Wound Abscess
         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
    Viral Upper Respiratory Tract Infection
         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
    Vestibular Neuronitis
         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
    Urosepsis
         subjects affected / exposed
    19 / 9067 (0.21%)
    19 / 9077 (0.21%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Urinary Tract Infection Bacterial
         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
    Viral Infection
         subjects affected / exposed
    6 / 9067 (0.07%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Sepsis
         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
    Wound Infection
         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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    34 / 9067 (0.37%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abnormal Loss Of Weight
         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
    Cholesterosis
         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
    Cachexia
         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
    Decreased Appetite
         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
    Fluid Overload
         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
    Failure To Thrive
         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 / 1
    0 / 0
    Diabetic Ketoacidosis
         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
    Diabetes Mellitus
         subjects affected / exposed
    22 / 9067 (0.24%)
    29 / 9077 (0.32%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes With Hyperosmolarity
         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
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    14 / 9067 (0.15%)
    22 / 9077 (0.24%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Complication
         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 / 1
    Hyperglycaemia
         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 / 0
    Hyperkalaemia
         subjects affected / exposed
    16 / 9067 (0.18%)
    3 / 9077 (0.03%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         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
    Glucose Tolerance Impaired
         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
    Haemochromatosis
         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
    Gout
         subjects affected / exposed
    4 / 9067 (0.04%)
    9 / 9077 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperammonaemia
         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
    Malnutrition
         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
    Hypovolaemia
         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
    Hyponatraemia
         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
    Hyperosmolar State
         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
    Hypoglycaemia
         subjects affected / exposed
    20 / 9067 (0.22%)
    17 / 9077 (0.19%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         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
    Hypokalaemia
         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
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    11 / 9067 (0.12%)
    5 / 9077 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    5 / 9067 (0.06%)
    7 / 9077 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour Lysis 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 / 1
    0 / 0
    Overweight
         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
    Type 1 Diabetes Mellitus
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ezetimibe/Simvastatin Simvastatin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5486 / 9067 (60.51%)
    5472 / 9077 (60.28%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    580 / 9067 (6.40%)
    642 / 9077 (7.07%)
         occurrences all number
    580
    642
    Nervous system disorders
    Headache
         subjects affected / exposed
    467 / 9067 (5.15%)
    520 / 9077 (5.73%)
         occurrences all number
    467
    520
    Dizziness
         subjects affected / exposed
    875 / 9067 (9.65%)
    909 / 9077 (10.01%)
         occurrences all number
    875
    909
    General disorders and administration site conditions
    Chest Pain
         subjects affected / exposed
    694 / 9067 (7.65%)
    731 / 9077 (8.05%)
         occurrences all number
    694
    731
    Non-Cardiac Chest Pain
         subjects affected / exposed
    554 / 9067 (6.11%)
    543 / 9077 (5.98%)
         occurrences all number
    554
    543
    Fatigue
         subjects affected / exposed
    720 / 9067 (7.94%)
    756 / 9077 (8.33%)
         occurrences all number
    720
    756
    Oedema Peripheral
         subjects affected / exposed
    520 / 9067 (5.74%)
    551 / 9077 (6.07%)
         occurrences all number
    520
    551
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    540 / 9067 (5.96%)
    552 / 9077 (6.08%)
         occurrences all number
    540
    552
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    702 / 9067 (7.74%)
    740 / 9077 (8.15%)
         occurrences all number
    702
    740
    Dyspnoea
         subjects affected / exposed
    787 / 9067 (8.68%)
    815 / 9077 (8.98%)
         occurrences all number
    787
    815
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1001 / 9067 (11.04%)
    914 / 9077 (10.07%)
         occurrences all number
    1001
    914
    Muscle Spasms
         subjects affected / exposed
    616 / 9067 (6.79%)
    576 / 9077 (6.35%)
         occurrences all number
    616
    576
    Musculoskeletal Pain
         subjects affected / exposed
    581 / 9067 (6.41%)
    535 / 9077 (5.89%)
         occurrences all number
    581
    535
    Back Pain
         subjects affected / exposed
    866 / 9067 (9.55%)
    825 / 9077 (9.09%)
         occurrences all number
    866
    825
    Pain In Extremity
         subjects affected / exposed
    955 / 9067 (10.53%)
    899 / 9077 (9.90%)
         occurrences all number
    955
    899
    Myalgia
         subjects affected / exposed
    954 / 9067 (10.52%)
    908 / 9077 (10.00%)
         occurrences all number
    954
    908
    Infections and infestations
    Influenza
         subjects affected / exposed
    461 / 9067 (5.08%)
    483 / 9077 (5.32%)
         occurrences all number
    461
    483
    Bronchitis
         subjects affected / exposed
    477 / 9067 (5.26%)
    450 / 9077 (4.96%)
         occurrences all number
    477
    450
    Nasopharyngitis
         subjects affected / exposed
    618 / 9067 (6.82%)
    577 / 9077 (6.36%)
         occurrences all number
    618
    577

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 May 2007
    Clarified the entry criteria, criteria for increasing the simvastatin dose, entry of participants from the EARLY ACS study into the IMPROVE-IT Study, and data capture for suspected clinical endpoint events. Clarified to investigators that suspected clinical endpoint events are not to be reported as adverse events. Added assessments for cardiovascular biomarkers, pharmacoeconomic factors, quality of life factors, and renal function.
    26 Oct 2007
    Closed enrollment of new subjects with a diagnosis of STEMI; capped the number of STEMI participants at approximately 4,000; raised the number of participants from 10,000 to 12,500; raised the number of primary endpoint event from 2,955 to 5,250; increased the estimated duration of the whole study to 66 months.
    08 May 2008
    Increased enrollment to a maximum of 18,000 participants from the previous number of 12,500 subjects, while the minimum number of primary endpoint events remained at 5,250.
    16 Nov 2008
    Added a second interim analysis when approximately 75% of the expected total primary events were available; allowed a participant to decline to have his/her simvastatin dose increased to 80 mg (or to return to the 40 mg dose, if already receiving 80 mg) and continue in the trial at the initial 40 mg dose.
    07 Jul 2011
    Added a second interim analysis when approximately 75% of the expected total primary events are available; described changes to the USA labeling for simvastatin that effected changes to the current IMPROVE-IT Trial; Made changes to the trial as a consequence of the USA labeling changes: Restricted the highest dose of simvastatin 80 mg to those participants who tolerated that highest dose for 12 months or more without evidence of significant muscle toxicity; Prohibited new participants from having their dose of simvastatin increased from 40 mg to 80 mg; Restricted the dose of simvastatin to 40 mg for those participants who received concomitant treatment with amlodipine or ranolazine. Provided instructions to investigators for how manage participants as necessary to comply with the restrictions on the simvastatin 80 mg dose and concomitant use of amlodipine or ranolazine.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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