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    Clinical Trial Results:
    A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy

    Summary
    EudraCT number
    		 2013-004494-28
    Trial protocol
    		 GB   CZ   IT   HU   DE   BG   ES   PL   LT   SK   FR  
    Global end of trial date
    30 Oct 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Nov 2019
    First version publication date
    16 Nov 2019
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    28431754DNE3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02065791
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Route 202, Raritan, NJ 08869, United States,
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.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
    30 Oct 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Oct 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Oct 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objectives of this study was to assess the efficacy of canagliflozin relative to placebo in reducing the composite endpoint of doubling of serum creatinine, end-stage kidney disease (ESKD), and renal or cardiovascular (CV) death in subjects with type 2 diabetes mellitus (T2DM), Stage 2 or 3 chronic kidney disease (CKD) and macroalbuminuria who were receiving standard of care.
    Protection of trial subjects
    Safety was evaluated throughout the study and included adverse events (AEs), hypoglycemic episodes, clinical safety laboratory tests (hematology, serum chemistry, urinalysis), and vital sign measurements (blood pressure and pulse rate).
    Background therapy
    		 Standard of care including a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB).
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Feb 2014
    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
    Slovakia: 66
    Country: Number of subjects enrolled
    South Africa: 62
    Country: Number of subjects enrolled
    Spain: 141
    Country: Number of subjects enrolled
    Taiwan: 37
    Country: Number of subjects enrolled
    Ukraine: 371
    Country: Number of subjects enrolled
    United Arab Emirates: 1
    Country: Number of subjects enrolled
    United Kingdom: 118
    Country: Number of subjects enrolled
    United States: 707
    Country: Number of subjects enrolled
    Argentina: 426
    Country: Number of subjects enrolled
    Australia: 38
    Country: Number of subjects enrolled
    Brazil: 314
    Country: Number of subjects enrolled
    Bulgaria: 29
    Country: Number of subjects enrolled
    Canada: 172
    Country: Number of subjects enrolled
    Chile: 52
    Country: Number of subjects enrolled
    China: 129
    Country: Number of subjects enrolled
    Colombia: 94
    Country: Number of subjects enrolled
    Czech Republic: 57
    Country: Number of subjects enrolled
    France: 61
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Guatemala: 55
    Country: Number of subjects enrolled
    Hungary: 135
    Country: Number of subjects enrolled
    India: 144
    Country: Number of subjects enrolled
    Italy: 90
    Country: Number of subjects enrolled
    Japan: 110
    Country: Number of subjects enrolled
    Korea, Republic of: 122
    Country: Number of subjects enrolled
    Lithuania: 7
    Country: Number of subjects enrolled
    Malaysia: 135
    Country: Number of subjects enrolled
    Mexico: 303
    Country: Number of subjects enrolled
    New Zealand: 61
    Country: Number of subjects enrolled
    Philippines: 71
    Country: Number of subjects enrolled
    Poland: 50
    Country: Number of subjects enrolled
    Romania: 59
    Country: Number of subjects enrolled
    Russian Federation: 133
    Country: Number of subjects enrolled
    Serbia: 40
    Worldwide total number of subjects
    4401
    EEA total number of subjects
    824
    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)
    2344
    From 65 to 84 years
    2041
    85 years and over
    16

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 12,900 subjects were prescreened, of those, 8,932 were screened. A total of 4,401 subjects were randomized, with 2,199 and 2,202 subjects assigned to placebo and canagliflozin 100 mg, respectively.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo orally once daily.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo tablet was administered orally once daily.

    Arm title
    		 Canagliflozin 100 mg
    Arm description
    		 Subjects received canagliflozin 100 milligram (mg) orally once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Canagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Canagliflozin 100 mg over-encapsulated tablet was administered orally once daily.

    Number of subjects in period 1
    		Placebo Canagliflozin 100 mg
    Started
    2199
    2202
    Treated
    2197
    2200
    Completed
    2174
    2187
    Not completed
    25
    15
         Consent withdrawn by subject
    11
    5
         Other - closed site
    1
    1
         Lost to follow-up
    13
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received canagliflozin 100 milligram (mg) orally once daily.

    Reporting group values
    		 Placebo Canagliflozin 100 mg Total
    Number of subjects
    		 2199 2202 4401
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1151 1193 2344
        From 65 to 84 years
    		 1038 1003 2041
        85 years and over
    		 10 6 16
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 63.2 ( 9.23 ) 62.9 ( 9.17 ) -
    Title for Gender
    Units: subjects
        Female
    		 732 762 1494
        Male
    		 1467 1440 2907

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received canagliflozin 100 milligram (mg) orally once daily.

    Primary: Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or CV Death

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    End point title
    		 Primary Composite Endpoint of Doubling of Serum Creatinine (DoSC), End-stage Kidney Disease (ESKD), and Renal or CV Death
    End point description
    Primary composite endpoint included composite of DoSC, ESKD, and renal/CV death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory (CL) measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or estimated glomerular filtration rate (eGFR) value of less than (<)15 milliliters per minute per 1.73 square meters (mL/min/1.73 m^2) (sustained and confirmed by repeat CL measure after at least 30 days and preferably within 60 days). Renal death: death in subjects who reached ESKD, die without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of primary composite endpoint are presented. Intent-to-treat (ITT) population: all randomized subjects.
    End point type
    Primary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    61.24
    43.21
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Canagliflozin 100 mg v Placebo
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.82

    Secondary: Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)

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    End point title
    		 Composite Endpoint of CV Death and Hospitalized Heart Failure (HHF)
    End point description
    The composite endpoint included CV death and HHF. CV death included death due to myocardial infraction (MI), stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event is CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the composite endpoint of CV death and HHF are presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    45.44
    31.47
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.83

    Secondary: Major Adverse Cardiac Event (MACE)

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    End point title
    		 Major Adverse Cardiac Event (MACE)
    End point description
    The composite endpoint included CV death, non-fatal MI, and non-fatal stroke (that is, 3-point MACE). Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    48.67
    38.71
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0121
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.95

    Secondary: Hospitalized Heart Failure (HHF)

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    End point title
    		 Hospitalized Heart Failure (HHF)
    End point description
    Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rates estimated based on the time to the first occurrence of hospitalized heart failure were presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    25.33
    15.65
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.47
         upper limit
    		 0.8

    Secondary: Renal Composite Endpoint

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    End point title
    		 Renal Composite Endpoint
    End point description
    The renal composite endpoint included DoSC, ESKD, and renal death. DoSC: from baseline average determination (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). ESKD: initiation of maintenance dialysis for at least 30 days, or renal transplantation, or an eGFR value of <15 mL/min/1.73 m^2 (sustained and confirmed by repeat central laboratory measure after at least 30 days and preferably within 60 days). Renal death: death in subjects who reached ESKD, die without initiating renal replacement therapy, and no other cause of death was determined via adjudication. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the renal composite endpoint are presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    40.36
    26.99
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.81

    Secondary: Cardiovascular (CV) Death

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    End point title
    		 Cardiovascular (CV) Death
    End point description
    CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event is a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of CV death are presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    24.38
    19.01
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0502
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 1

    Secondary: All-cause Mortality

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    End point title
    		 All-cause Mortality
    End point description
    Adjudication of these events by Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on time to first occurrence of all-cause mortality are presented. ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    35.00
    29.04
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0727
    Method
    		 Cox proportional hazard
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.02

    Secondary: CV Composite Endpoint

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    End point title
    		 CV Composite Endpoint
    End point description
    The CV composite endpoint included CV death, non-fatal MI, non-fatal stroke, hospitalized heart failure, and hospitalized unstable angina. CV death included death due to MI, stroke, heart failure, sudden death, death during a CV procedure or as a result of procedure-related complications, or death due to other CV causes. For analytic purposes, undetermined causes of death were considered CV deaths. In determining whether a death event is a CV in nature, the EAC took into consideration both the proximate and underlying causes. Adjudication of these events by the EAC was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of the CV composite endpoint are presented. The ITT population consisted of all randomized subjects.
    End point type
    Secondary
    End point timeframe
    Up to 4.6 years
    End point values
    		 Placebo Canagliflozin 100 mg
    Number of subjects analysed
    2199
    2202
    Units: Event rate per 1000 subject-years
        number (not applicable)
    66.95
    49.35
    Statistical analysis title
    		 Statistical Analysis
    Statistical analysis description
    Comparison for canagliflozin versus placebo is reported here.
    Comparison groups
    Placebo v Canagliflozin 100 mg
    Number of subjects included in analysis
    4401
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0001
    Method
    		 Cox proportional hazards
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.86

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 4.6 years
    Adverse event reporting additional description
    Safety population included all randomized subjects who received at least 1 dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally once daily.

    Reporting group title
    Canagliflozin 100 mg
    Reporting group description
    		 Subjects received canagliflozin 100 milligram (mg) orally once daily.

    Serious adverse events
    		 Placebo Canagliflozin 100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    806 / 2197 (36.69%)
    737 / 2200 (33.50%)
         number of deaths (all causes)
    193
    164
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Leukaemia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma Gastric
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma of Colon
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Lymphoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Neoplasm of Bladder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    4 / 2197 (0.18%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neoplasm
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Cancer Metastatic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    2 / 2197 (0.09%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Colon Neoplasm
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Invasive Breast Carcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Benign Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung Neoplasm
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung Neoplasm Malignant
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant Melanoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Neoplasm of Unknown Primary Site
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningioma Malignant
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Bone
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Liver
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Renal Cell Carcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine Tumour
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma Stage Ii
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Adenocarcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Endometrioid Carcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pancreatic Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary Thyroid Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Carcinoma Metastatic
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pituitary Tumour Benign
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    4 / 2197 (0.18%)
    8 / 2200 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Adenoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma Stage I
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Neoplasm
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Oncocytoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Neoplasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of Lung
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous Cell Carcinoma of Skin
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma of the Vulva
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transitional Cell Cancer of Renal Pelvis and Ureter Metastatic
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Cancer of the Renal Pelvis and Ureter
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Uterine Cancer
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated Hypertension
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Dissection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic Stenosis
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial Disorder
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Insufficiency
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Deep Vein Thrombosis
         subjects affected / exposed
    7 / 2197 (0.32%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Vascular Disorder
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism Arterial
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    8 / 2197 (0.36%)
    9 / 2200 (0.41%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    7 / 2197 (0.32%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    9 / 2197 (0.41%)
    9 / 2200 (0.41%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive Emergency
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    3 / 2197 (0.14%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent Claudication
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche Syndrome
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrosis Ischaemic
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    5 / 2197 (0.23%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    11 / 2197 (0.50%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Occlusion
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral Vascular Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Venous Disease
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Thrombotic Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock Haemorrhagic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subclavian Artery Stenosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Occlusion
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained Products of Conception
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrophy
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Death
         subjects affected / exposed
    1 / 2197 (0.05%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Chest Discomfort
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication Associated with Device
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Critical Illness
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cyst
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    6 / 2197 (0.27%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 6
    0 / 7
    Drowning
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Oedema
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Hernia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza Like Illness
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Oedema
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Necrobiosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    2 / 2197 (0.09%)
    8 / 2200 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Swelling
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    8 / 2197 (0.36%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 8
    0 / 3
    Sudden Cardiac Death
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired Phimosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Disorder
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile Dysfunction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital Swelling
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal Prolapse
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    8 / 2197 (0.36%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Respiratory Failure
         subjects affected / exposed
    6 / 2197 (0.27%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Apnoeic Attack
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    16 / 2197 (0.73%)
    9 / 2200 (0.41%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Respiratory Failure
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 2197 (0.14%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at Rest
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Haematoma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasal Polyps
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Septum Perforation
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    6 / 2197 (0.27%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic Pain
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pulmonary Arterial Hypertension
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Congestion
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    3 / 2197 (0.14%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pulmonary Fibrosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Infarction
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary Mass
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    7 / 2197 (0.32%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Respiratory Depression
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    10 / 2197 (0.46%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    0 / 12
    1 / 11
         deaths causally related to treatment / all
    0 / 3
    1 / 4
    Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Confusional State
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance-Induced Psychotic Disorder
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device Malfunction
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Bile Duct Obstruction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Sclerosing
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    5 / 2197 (0.23%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    4 / 2197 (0.18%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 2197 (0.05%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 2197 (0.09%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Hepatitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Aspiration Bronchial
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Biopsy Kidney
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    20 / 2197 (0.91%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Blood Glucose Increased
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood Osmolarity Decreased
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Urea Increased
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 2197 (0.05%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin Decreased
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin Increased
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Anaesthetic Complication
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Reocclusion
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Vascular Graft Occlusion
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Expired Product Administered
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    2 / 2197 (0.09%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body in Eye
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture Displacement
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    2 / 2197 (0.09%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Injury
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Strain
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thrombosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Intestinal Perforation
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Soft Tissue Injury
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Subdural Haematoma
         subjects affected / exposed
    3 / 2197 (0.14%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Intracranial Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         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 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    5 / 2197 (0.23%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    8 / 2197 (0.36%)
    12 / 2200 (0.55%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Left Ventricular Failure
         subjects affected / exposed
    4 / 2197 (0.18%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    38 / 2197 (1.73%)
    38 / 2200 (1.73%)
         occurrences causally related to treatment / all
    1 / 40
    1 / 42
         deaths causally related to treatment / all
    0 / 10
    0 / 7
    Angina Pectoris
         subjects affected / exposed
    14 / 2197 (0.64%)
    21 / 2200 (0.95%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    29 / 2197 (1.32%)
    17 / 2200 (0.77%)
         occurrences causally related to treatment / all
    0 / 33
    2 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    3 / 2197 (0.14%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    19 / 2197 (0.86%)
    16 / 2200 (0.73%)
         occurrences causally related to treatment / all
    0 / 22
    1 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial Flutter
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         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
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block First Degree
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brugada Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    7 / 2197 (0.32%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Cardiac Asthma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    50 / 2197 (2.28%)
    34 / 2200 (1.55%)
         occurrences causally related to treatment / all
    1 / 54
    1 / 43
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Cardiac Failure Acute
         subjects affected / exposed
    6 / 2197 (0.27%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Failure Chronic
         subjects affected / exposed
    4 / 2197 (0.18%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure Congestive
         subjects affected / exposed
    48 / 2197 (2.18%)
    24 / 2200 (1.09%)
         occurrences causally related to treatment / all
    0 / 59
    2 / 27
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac Fibrillation
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Tamponade
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    3 / 2197 (0.14%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Cardiogenic Shock
         subjects affected / exposed
    8 / 2197 (0.36%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    Cardiomyopathy
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Left Ventricular Failure
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Right Ventricular Failure
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor Pulmonale
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    23 / 2197 (1.05%)
    9 / 2200 (0.41%)
         occurrences causally related to treatment / all
    1 / 27
    1 / 9
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Coronary Artery Insufficiency
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    0 / 2197 (0.00%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    6 / 2197 (0.27%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left Ventricular Failure
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    27 / 2197 (1.23%)
    22 / 2200 (1.00%)
         occurrences causally related to treatment / all
    3 / 31
    0 / 23
         deaths causally related to treatment / all
    0 / 11
    0 / 9
    Myocardial Ischaemia
         subjects affected / exposed
    8 / 2197 (0.36%)
    8 / 2200 (0.36%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocarditis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless Electrical Activity
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right Ventricular Failure
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid Valve Incompetence
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amputation Stump Pain
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar Migraine
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Injury
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Oedema
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carotid Artery Occlusion
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    8 / 2197 (0.36%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda Equina Syndrome
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebellar Infarction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Stroke
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Haematoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Haemorrhage
         subjects affected / exposed
    4 / 2197 (0.18%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Hypoperfusion
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Infarction
         subjects affected / exposed
    7 / 2197 (0.32%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral Ischaemia
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    36 / 2197 (1.64%)
    30 / 2200 (1.36%)
         occurrences causally related to treatment / all
    1 / 36
    2 / 30
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    Cervical Radiculopathy
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clonus
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed Level of Consciousness
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Autonomic Neuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Hyperosmolar Coma
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural Arteriovenous Fistula
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic Cerebral Infarction
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic Stroke
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Haemorrhagic Stroke
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic Transformation Stroke
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Headache
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Coma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Encephalopathy
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Mass
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic Cerebral Infarction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Neuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    17 / 2197 (0.77%)
    14 / 2200 (0.64%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 14
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Lacunar Infarction
         subjects affected / exposed
    4 / 2197 (0.18%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Language Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral Radiculopathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's Disease
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Sensorimotor Neuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Piriformis Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Progressive Supranuclear Palsy
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somnolence
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    3 / 2197 (0.14%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension Headache
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic Infarction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    4 / 2197 (0.18%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Encephalopathy
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis Cerebral
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 2197 (0.46%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Vitamin B12 Deficiency
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicytopenia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic Anaemia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic Anaemia
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic Anaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle Closure Glaucoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    9 / 2197 (0.41%)
    8 / 2200 (0.36%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Subcapsular
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Retinopathy
         subjects affected / exposed
    4 / 2197 (0.18%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Haemorrhage
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid Ptosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Maculopathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neovascular Age-Related Macular Degeneration
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic Ischaemic Neuropathy
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    2 / 2197 (0.09%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhegmatogenous Retinal Detachment
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tractional Retinal Detachment
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision Blurred
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Adhesions
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Fat Apron
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Incarcerated Hernia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gastroparesis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    2 / 2197 (0.09%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical Fistula
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epulis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Faeces Discoloured
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 2197 (0.05%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    6 / 2197 (0.27%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    1 / 2197 (0.05%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    1 / 2197 (0.05%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal Perforation
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Large Intestine Polyp
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukoplakia Oral
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Pancreatitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    3 / 2197 (0.14%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Polyp
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Haemorrhage
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subileus
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen Tongue
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    1 / 2197 (0.05%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 2197 (0.18%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    10 / 2197 (0.46%)
    15 / 2200 (0.68%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ulcer
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Eruption
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Angioedema
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic Ulcer
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Generalised
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    8 / 2197 (0.36%)
    18 / 2200 (0.82%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    50 / 2197 (2.28%)
    41 / 2200 (1.86%)
         occurrences causally related to treatment / all
    6 / 52
    4 / 43
         deaths causally related to treatment / all
    0 / 5
    1 / 3
    Anuria
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Azotaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cyst
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    12 / 2197 (0.55%)
    12 / 2200 (0.55%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Diabetic Nephropathy
         subjects affected / exposed
    10 / 2197 (0.46%)
    12 / 2200 (0.55%)
         occurrences causally related to treatment / all
    0 / 11
    2 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    End Stage Renal Disease
         subjects affected / exposed
    23 / 2197 (1.05%)
    16 / 2200 (0.73%)
         occurrences causally related to treatment / all
    1 / 24
    3 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Glomerulonephritis Chronic
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    4 / 2197 (0.18%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic Bladder
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    9 / 2197 (0.41%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Renal Impairment
         subjects affected / exposed
    7 / 2197 (0.32%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    1 / 7
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Injury
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Urinary Incontinence
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate Antidiuretic Hormone Secretion
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Mass
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Wall Haematoma
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty Arthritis
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Displacement
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    5 / 2197 (0.23%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    5 / 2197 (0.23%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic Arthropathy
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis Deformans
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    11 / 2197 (0.50%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 2197 (0.00%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Symphysiolysis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger Finger
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Foraminal Stenosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Sepsis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abscess Limb
         subjects affected / exposed
    0 / 2197 (0.00%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Abscess
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Hepatitis B
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous Fistula Site Infection
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical Pneumonia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Pyelonephritis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    7 / 2197 (0.32%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter Colitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    26 / 2197 (1.18%)
    18 / 2200 (0.82%)
         occurrences causally related to treatment / all
    1 / 28
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis Staphylococcal
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    2 / 2197 (0.09%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 2197 (0.09%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysentery
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis Infectious
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Bacterial
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    5 / 2197 (0.23%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    15 / 2197 (0.68%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    3 / 20
    0 / 11
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Gas Gangrene
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    19 / 2197 (0.86%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Bacterial
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Bacterial Infection
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         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
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Echinococciasis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    6 / 2197 (0.27%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection in An Immunocompromised Host
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infective Exacerbation of Chronic Obstructive Airways Disease
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis Fungal
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    6 / 2197 (0.27%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningitis Bacterial
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Necrotising Fasciitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Onychomycosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Opisthorchiasis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    11 / 2197 (0.50%)
    11 / 2200 (0.50%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Acute
         subjects affected / exposed
    0 / 2197 (0.00%)
    2 / 2200 (0.09%)
         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
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal Abscess
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    86 / 2197 (3.91%)
    63 / 2200 (2.86%)
         occurrences causally related to treatment / all
    1 / 104
    1 / 72
         deaths causally related to treatment / all
    0 / 15
    1 / 13
    Pneumonia Bacterial
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Influenzal
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Streptococcal
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Viral
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    3 / 2197 (0.14%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas Bronchitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    5 / 2197 (0.23%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    2 / 2197 (0.09%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    2 / 2197 (0.09%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Abscess
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Bronchiolitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Abscess
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrub Typhus
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    12 / 2197 (0.55%)
    11 / 2200 (0.50%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Septic Shock
         subjects affected / exposed
    12 / 2197 (0.55%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 6
    0 / 5
    Soft Tissue Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Bacteraemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    2 / 2197 (0.09%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Infection
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    0 / 2200 (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
    3 / 2197 (0.14%)
    3 / 2200 (0.14%)
         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
    21 / 2197 (0.96%)
    25 / 2200 (1.14%)
         occurrences causally related to treatment / all
    9 / 25
    12 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Urinary Tract Infection Fungal
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    3 / 2197 (0.14%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Viral Infection
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         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 / 2197 (0.05%)
    0 / 2200 (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
    1 / 2197 (0.05%)
    6 / 2200 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    8 / 2197 (0.36%)
    4 / 2200 (0.18%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Diabetes Mellitus
         subjects affected / exposed
    10 / 2197 (0.46%)
    5 / 2200 (0.23%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    12 / 2197 (0.55%)
    7 / 2200 (0.32%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    2 / 2197 (0.09%)
    9 / 2200 (0.41%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Ketosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Metabolic Decompensation
         subjects affected / exposed
    3 / 2197 (0.14%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Retention
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    11 / 2197 (0.50%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    10 / 2197 (0.46%)
    10 / 2200 (0.45%)
         occurrences causally related to treatment / all
    0 / 10
    4 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperlipidaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    11 / 2197 (0.50%)
    17 / 2200 (0.77%)
         occurrences causally related to treatment / all
    3 / 11
    6 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 2197 (0.14%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 2197 (0.18%)
    3 / 2200 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoproteinaemia
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    0 / 2197 (0.00%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    6 / 2197 (0.27%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metabolic Disorder
         subjects affected / exposed
    1 / 2197 (0.05%)
    0 / 2200 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 2197 (0.05%)
    2 / 2200 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    2 / 2197 (0.09%)
    1 / 2200 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Canagliflozin 100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1447 / 2197 (65.86%)
    1320 / 2200 (60.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    193 / 2197 (8.78%)
    144 / 2200 (6.55%)
         occurrences all number
    313
    196
    Hypotension
         subjects affected / exposed
    30 / 2197 (1.37%)
    57 / 2200 (2.59%)
         occurrences all number
    31
    71
    General disorders and administration site conditions
    Oedema Peripheral
         subjects affected / exposed
    199 / 2197 (9.06%)
    119 / 2200 (5.41%)
         occurrences all number
    235
    135
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    81 / 2197 (3.69%)
    80 / 2200 (3.64%)
         occurrences all number
    93
    94
    Dyspnoea
         subjects affected / exposed
    46 / 2197 (2.09%)
    35 / 2200 (1.59%)
         occurrences all number
    49
    38
    Investigations
    Blood Creatinine Increased
         subjects affected / exposed
    185 / 2197 (8.42%)
    140 / 2200 (6.36%)
         occurrences all number
    205
    152
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    80 / 2197 (3.64%)
    63 / 2200 (2.86%)
         occurrences all number
    85
    63
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    45 / 2197 (2.05%)
    43 / 2200 (1.95%)
         occurrences all number
    47
    46
    Nervous system disorders
    Diabetic Neuropathy
         subjects affected / exposed
    69 / 2197 (3.14%)
    56 / 2200 (2.55%)
         occurrences all number
    74
    57
    Headache
         subjects affected / exposed
    65 / 2197 (2.96%)
    69 / 2200 (3.14%)
         occurrences all number
    82
    81
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    136 / 2197 (6.19%)
    77 / 2200 (3.50%)
         occurrences all number
    144
    81
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    50 / 2197 (2.28%)
    46 / 2200 (2.09%)
         occurrences all number
    54
    50
    Eye disorders
    Cataract
         subjects affected / exposed
    80 / 2197 (3.64%)
    58 / 2200 (2.64%)
         occurrences all number
    94
    65
    Diabetic Retinopathy
         subjects affected / exposed
    55 / 2197 (2.50%)
    65 / 2200 (2.95%)
         occurrences all number
    56
    74
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    82 / 2197 (3.73%)
    80 / 2200 (3.64%)
         occurrences all number
    93
    91
    Diarrhoea
         subjects affected / exposed
    105 / 2197 (4.78%)
    91 / 2200 (4.14%)
         occurrences all number
    120
    100
    Nausea
         subjects affected / exposed
    52 / 2197 (2.37%)
    54 / 2200 (2.45%)
         occurrences all number
    62
    58
    Vomiting
         subjects affected / exposed
    48 / 2197 (2.18%)
    41 / 2200 (1.86%)
         occurrences all number
    55
    43
    Skin and subcutaneous tissue disorders
    Skin Ulcer
         subjects affected / exposed
    70 / 2197 (3.19%)
    85 / 2200 (3.86%)
         occurrences all number
    89
    103
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    51 / 2197 (2.32%)
    50 / 2200 (2.27%)
         occurrences all number
    63
    56
    Renal Impairment
         subjects affected / exposed
    61 / 2197 (2.78%)
    42 / 2200 (1.91%)
         occurrences all number
    64
    45
    End Stage Renal Disease
         subjects affected / exposed
    52 / 2197 (2.37%)
    30 / 2200 (1.36%)
         occurrences all number
    57
    32
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    83 / 2197 (3.78%)
    81 / 2200 (3.68%)
         occurrences all number
    90
    87
    Back Pain
         subjects affected / exposed
    99 / 2197 (4.51%)
    94 / 2200 (4.27%)
         occurrences all number
    113
    105
    Pain in Extremity
         subjects affected / exposed
    54 / 2197 (2.46%)
    56 / 2200 (2.55%)
         occurrences all number
    61
    63
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    86 / 2197 (3.91%)
    83 / 2200 (3.77%)
         occurrences all number
    96
    104
    Gastroenteritis
         subjects affected / exposed
    51 / 2197 (2.32%)
    49 / 2200 (2.23%)
         occurrences all number
    53
    52
    Influenza
         subjects affected / exposed
    88 / 2197 (4.01%)
    87 / 2200 (3.95%)
         occurrences all number
    105
    93
    Nasopharyngitis
         subjects affected / exposed
    133 / 2197 (6.05%)
    130 / 2200 (5.91%)
         occurrences all number
    180
    184
    Onychomycosis
         subjects affected / exposed
    33 / 2197 (1.50%)
    45 / 2200 (2.05%)
         occurrences all number
    33
    46
    Pneumonia
         subjects affected / exposed
    52 / 2197 (2.37%)
    41 / 2200 (1.86%)
         occurrences all number
    61
    42
    Respiratory Tract Infection
         subjects affected / exposed
    44 / 2197 (2.00%)
    19 / 2200 (0.86%)
         occurrences all number
    63
    22
    Upper Respiratory Tract Infection
         subjects affected / exposed
    117 / 2197 (5.33%)
    90 / 2200 (4.09%)
         occurrences all number
    141
    109
    Urinary Tract Infection
         subjects affected / exposed
    185 / 2197 (8.42%)
    202 / 2200 (9.18%)
         occurrences all number
    271
    280
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    44 / 2197 (2.00%)
    24 / 2200 (1.09%)
         occurrences all number
    52
    26
    Hyperglycaemia
         subjects affected / exposed
    74 / 2197 (3.37%)
    54 / 2200 (2.45%)
         occurrences all number
    81
    67
    Hyperkalaemia
         subjects affected / exposed
    152 / 2197 (6.92%)
    129 / 2200 (5.86%)
         occurrences all number
    206
    153
    Hyperuricaemia
         subjects affected / exposed
    75 / 2197 (3.41%)
    64 / 2200 (2.91%)
         occurrences all number
    83
    70
    Hypoglycaemia
         subjects affected / exposed
    227 / 2197 (10.33%)
    213 / 2200 (9.68%)
         occurrences all number
    1128
    957

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Jun 2014
    The primary reason for Amendment INT-1 was to reflect recommendations from the US Food and Drug Administration (FDA) for this study.
    03 Feb 2015
    The primary reason for Amendment INT-2 was to revise inclusion criteria to allow subjects with higher baseline HbA1c values who may have benefited from the study treatment to participate in the study.
    29 Sep 2015
    The primary reason for Amendment INT-3 was to inform investigators of additional safety reporting requirements associated with DKA, which was identified as an adverse event of special interest.
    29 Jan 2016
    The primary reason for Amendment INT-4 was to expand the sample size from 3,700 to 4,200 subjects to increase the likelihood of accruing endpoints within the primary composite.
    06 May 2016
    The primary reason for Amendment INT-5 was to add new safety information and guidance regarding subject management surrounding the event of lower-extremity amputation.
    06 Sep 2017
    The primary reason for Amendment INT-6 was to decrease the number of primary composite events required for the interim analysis from 540 to 405, based on internal and external data of the effects of SGLT2 inhibitors on renal endpoints indicating that the beneficial effects of canagliflozin on renal outcomes may be detected with fewer events in the primary composite endpoint.

    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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