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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multinational Trial, to Assess the Prevention of Thrombotic Events with Ticagrelor Compared to Placebo on a Background of Acetyl Salicylic Acid (ASA) Therapy in Patients with History of Myocardial Infarction

    Summary
    EudraCT number
    		 2009-017242-30
    Trial protocol
    		 NL   GB   DE   HU   RO   CZ   SK   PL   BE   ES   SE   IT   NO   BG  
    Global end of trial date
    03 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2016
    First version publication date
    04 May 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5132C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 PEGASUS-TIMI 54: NOT APPLICABLE
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, 431 83
    Public contact
    Anders Himmelmann, AstraZeneca AB, +46 (0)31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Anders Himmelmann, AstraZeneca AB, +46 (0)31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, 431 83
    Public contact
    Anders Himmelmann, AstraZeneca AB, +46 (0)31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Anders Himmelmann, AstraZeneca AB, +46 (0)31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    22 Jan 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to compare the effect of long-term treatment with ticagrelor vs. placebo on a background of ASA on the event rate of the composite of cardiovascular death, non-fatal MI, or non-fatal stroke in patients with history of MI and high risk of developing atherothrombotic events. The primary efficacy variable is time to first occurrence of any event after randomization from the composite of cardiovascular death, non-fatal MI, or non-fatal stroke.
    Protection of trial subjects
    The Independent Data Monitoring Committee was an external, independent group with relevant expertise in cardiology, clinical trials, and biostatistics. The Committee met on a regular basis during the study to among other things make recommendations regarding the continuing safety of current participants and those yet to be recruited.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Oct 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 499
    Country: Number of subjects enrolled
    Australia: 327
    Country: Number of subjects enrolled
    Belgium: 431
    Country: Number of subjects enrolled
    Brazil: 864
    Country: Number of subjects enrolled
    Bulgaria: 447
    Country: Number of subjects enrolled
    Canada: 1306
    Country: Number of subjects enrolled
    Chile: 322
    Country: Number of subjects enrolled
    China: 383
    Country: Number of subjects enrolled
    Colombia: 528
    Country: Number of subjects enrolled
    Czech Republic: 870
    Country: Number of subjects enrolled
    France: 333
    Country: Number of subjects enrolled
    Germany: 924
    Country: Number of subjects enrolled
    Hungary: 831
    Country: Number of subjects enrolled
    Italy: 392
    Country: Number of subjects enrolled
    Japan: 903
    Country: Number of subjects enrolled
    Netherlands: 1560
    Country: Number of subjects enrolled
    Norway: 336
    Country: Number of subjects enrolled
    Peru: 245
    Country: Number of subjects enrolled
    Philippines: 250
    Country: Number of subjects enrolled
    Poland: 1399
    Country: Number of subjects enrolled
    Korea, Republic of: 506
    Country: Number of subjects enrolled
    Romania: 404
    Country: Number of subjects enrolled
    Russian Federation: 1061
    Country: Number of subjects enrolled
    Slovakia: 475
    Country: Number of subjects enrolled
    South Africa: 473
    Country: Number of subjects enrolled
    Spain: 535
    Country: Number of subjects enrolled
    Sweden: 507
    Country: Number of subjects enrolled
    Turkey: 180
    Country: Number of subjects enrolled
    Ukraine: 623
    Country: Number of subjects enrolled
    United Kingdom: 647
    Country: Number of subjects enrolled
    United States: 2601
    Worldwide total number of subjects
    21162
    EEA total number of subjects
    10091
    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)
    9627
    From 65 to 84 years
    11319
    85 years and over
    216

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 21326 patients were enrolled. 164 enrolled patients were not randomzed (148 due to incorrect enrollment; 16 due to patient decision)

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ticagrelor 90 mg
    Arm description
    		 Ticagrelor 90 mg twice daily (BD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor 90 mg bd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ticagrelor 90 mg twice daily

    Arm title
    		 Ticagrelor 60 mg
    Arm description
    		 Ticagrelor 60 mg twice daily (BD)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor 60 mg bd
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ticagrelor 60 mg twice daily

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Chewable/dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo twice daily

    Number of subjects in period 1
    		Ticagrelor 90 mg Ticagrelor 60 mg Placebo
    Started
    7050
    7045
    7067
    Completed
    6995
    6989
    7014
    Not completed
    55
    56
    53
         Consent withdrawn by subject
    52
    50
    52
         Lost to follow-up
    3
    6
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ticagrelor 90 mg
    Reporting group description
    		 Ticagrelor 90 mg twice daily (BD)

    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    		 Ticagrelor 60 mg twice daily (BD)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Reporting group values
    		 Ticagrelor 90 mg Ticagrelor 60 mg Placebo Total
    Number of subjects
    		 7050 7045 7067 21162
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 3190 3283 3154 9627
        From 65-84 years
    		 3782 3690 3847 11319
        85 years and over
    		 78 72 66 216
    Age Continuous |
    Units: years
        arithmetic mean (standard deviation)
    		 65.4 ( 8.4 ) 65.2 ( 8.4 ) 65.4 ( 8.3 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 1682 1661 1717 5060
        Male
    		 5368 5384 5350 16102

    End points

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    End points reporting groups
    Reporting group title
    Ticagrelor 90 mg
    Reporting group description
    		 Ticagrelor 90 mg twice daily (BD)

    Reporting group title
    Ticagrelor 60 mg
    Reporting group description
    		 Ticagrelor 60 mg twice daily (BD)

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Primary: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 years from Randomization

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    End point title
    		 Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 years from Randomization
    End point description
    Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
    End point type
    Primary
    End point timeframe
    Randomization up to 47 months
    End point values
    		 Ticagrelor 90 mg Ticagrelor 60 mg Placebo
    Number of subjects analysed
    7050
    7045
    7067
    Units: Percentage of Patients
        number (not applicable)
    7.8
    7.8
    9
    Statistical analysis title
    		 Primary efficacy endpoint 90mg vs placebo
    Comparison groups
    Ticagrelor 90 mg v Placebo
    Number of subjects included in analysis
    14117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.008
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.96
    Statistical analysis title
    		 Primary efficacy endpoint 60mg vs placebo
    Comparison groups
    Ticagrelor 60 mg v Placebo
    Number of subjects included in analysis
    14112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0043
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.95

    Primary: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 years from first dose of study drug Units: Percentage of Patients

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    End point title
    		 Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 years from first dose of study drug Units: Percentage of Patients
    End point description
    A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of >= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug.
    End point type
    Primary
    End point timeframe
    First dosing up to 48 months
    End point values
    		 Ticagrelor 90 mg Ticagrelor 60 mg Placebo
    Number of subjects analysed
    6988
    6958
    6996
    Units: Percentage of Patients
        number (not applicable)
    2.6
    2.3
    1.1
    Statistical analysis title
    		 TIMI Major bleeding ticagrelor 90mg vs placebo
    Comparison groups
    Ticagrelor 90 mg v Placebo
    Number of subjects included in analysis
    13984
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.96
         upper limit
    		 3.7
    Statistical analysis title
    		 TIMI Major bleeding ticagrelor 60mg vs placebo
    Comparison groups
    Ticagrelor 60 mg v Placebo
    Number of subjects included in analysis
    13954
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    2.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.68
         upper limit
    		 3.21

    Secondary: Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 years from Randomization

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    End point title
    		 Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 years from Randomization
    End point description
    Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
    End point type
    Secondary
    End point timeframe
    Randomization up to 47 months
    End point values
    		 Ticagrelor 90 mg Ticagrelor 60 mg Placebo
    Number of subjects analysed
    7050
    7045
    7067
    Units: Percentage of Patients
        number (not applicable)
    2.9
    2.9
    3.4
    Statistical analysis title
    		 CV Death: ticagrelor 90 mg vs placebo
    Comparison groups
    Ticagrelor 90 mg v Placebo
    Number of subjects included in analysis
    14117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1547
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.06
    Statistical analysis title
    		 CV Death: ticagrelor 60 mg vs placebo
    Comparison groups
    Ticagrelor 60 mg v Placebo
    Number of subjects included in analysis
    14112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0676
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 1.01

    Secondary: Kaplan-Meier Estimate of the Percentage of Patients Who Died from Any Cause Within 3 years from Randomization

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    End point title
    		 Kaplan-Meier Estimate of the Percentage of Patients Who Died from Any Cause Within 3 years from Randomization
    End point description
    Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization
    End point type
    Secondary
    End point timeframe
    Randomization up to 47 months
    End point values
    		 Ticagrelor 90 mg Ticagrelor 60 mg Placebo
    Number of subjects analysed
    7050
    7045
    7067
    Units: Percentage of Patients
        number (not applicable)
    5.1
    4.7
    5.2
    Statistical analysis title
    		 All-cause mortality: ticagrelor 90 mg vs placebo
    Comparison groups
    Ticagrelor 90 mg v Placebo
    Number of subjects included in analysis
    14117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9851
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.16
    Statistical analysis title
    		 All-cause mortality ticagrelor 60 mg vs placebo
    Comparison groups
    Ticagrelor 60 mg v Placebo
    Number of subjects included in analysis
    14112
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.135
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.04

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    Ticagrelor 90mg bd
    Reporting group description
    		 -

    Reporting group title
    Ticagrelor 60mg bd
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo Ticagrelor 90mg bd Ticagrelor 60mg bd
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1757 / 6996 (25.11%)
    1918 / 6988 (27.45%)
    1853 / 6958 (26.63%)
         number of deaths (all causes)
    329
    333
    290
         number of deaths resulting from adverse events
    11
    5
    14
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acinic cell carcinoma of salivary gland
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute myeloid leukaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma gastric
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    3 / 6988 (0.04%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma of colon
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    7 / 6988 (0.10%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Adenolymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Adrenal adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ameloblastoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Anaplastic large cell lymphoma T- and null-cell types
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Anogenital warts
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Astrocytoma malignant
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical fibroxanthoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    B-cell lymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    9 / 6988 (0.13%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of bladder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of ureter
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign renal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign soft tissue neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Bile duct cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    11 / 6996 (0.16%)
    5 / 6988 (0.07%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder cancer recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    4 / 6988 (0.06%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder papilloma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    3 / 6988 (0.04%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Bone cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Bone sarcoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bowen's disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Brain neoplasm malignant
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer female
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    7 / 6988 (0.10%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer male
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Breast cancer recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brenner tumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchioloalveolar carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervix carcinoma stage 0
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Cholesteatoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choroid melanoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    7 / 6988 (0.10%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    14 / 6988 (0.20%)
    14 / 6958 (0.20%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Colon cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    7 / 6988 (0.10%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    0 / 5
    Colon neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colorectal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial cancer stage I
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epithelioid mesothelioma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Essential thrombocythaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fallopian tube cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibroma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Follicle centre lymphoma, follicular grade I, II, III stage IV
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gallbladder cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastric adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    8 / 6988 (0.11%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Gastrointestinal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Glioblastoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
    Glioblastoma multiforme
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    Haemangioma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Hepatic cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Hepatic neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatocellular carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hodgkin's disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypergammaglobulinaemia benign monoclonal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammatory pseudotumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine benign neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngeal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Laryngeal squamous cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leiomyosarcoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lentigo maligna
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Lip neoplasm malignant stage unspecified
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lipoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lung adenocarcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    Lung cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    14 / 6988 (0.20%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 8
    0 / 9
    0 / 3
    Lung carcinoma cell type unspecified recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage I
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage IV
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Lung neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung neoplasm malignant
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    17 / 6988 (0.24%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 17
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 9
    0 / 5
    Lymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Lymphoma cutis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoplasmacytoid lymphoma/immunocytoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Malignant anorectal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant ascites
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Malignant fibrous histiocytoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Malignant neoplasm of unknown primary site
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
    Malignant peritoneal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant pleural effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mediastinum neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Melanocytic naevus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningioma benign
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to bone
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to central nervous system
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to liver
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lung
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastases to pancreas
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Metastases to peritoneum
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Metastatic gastric cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 1
    Metastatic malignant melanoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    Metastatic neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Metastatic pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic salivary gland cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Monoclonal gammopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelofibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myeloproliferative disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal neoplasm benign
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Neoplasm malignant
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Neoplasm prostate
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neoplasm skin
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Neuroendocrine carcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuroendocrine tumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Non-Hodgkin's lymphoma recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage I
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma stage II
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma unspecified histology aggressive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Non-small cell lung cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Non-small cell lung cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Oesophageal carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    5 / 6988 (0.07%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    Oncocytoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oral cavity cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal cancer recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Ovarian cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Ovarian cancer stage III
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancoast's tumour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pancreatic carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    Pancreatic carcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    5 / 6988 (0.07%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    0 / 4
    Pancreatic neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Paranasal sinus neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penile squamous cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penis carcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleomorphic adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural mesothelioma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pleural mesothelioma malignant
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Polycythaemia vera
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    37 / 6996 (0.53%)
    38 / 6988 (0.54%)
    29 / 6958 (0.42%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 38
    0 / 29
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Prostate cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    8 / 6988 (0.11%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
    Prostate cancer recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer stage II
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Rectal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Rectosigmoid cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Renal cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cell carcinoma recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer recurrent
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salivary gland neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcomatoid mesothelioma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Small cell lung cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Small cell lung cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Small intestine carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Splenic marginal zone lymphoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Squamous cell carcinoma of lung
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Squamous cell carcinoma of pharynx
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid adenoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Thyroid neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tongue cancer metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Tumour associated fever
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tumour pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Undifferentiated nasopharyngeal carcinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral cancer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract neoplasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine leiomyoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angiodysplasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    13 / 6996 (0.19%)
    19 / 6988 (0.27%)
    19 / 6958 (0.27%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 20
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    Aortic dissection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Aortic dissection rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Aortic stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Aortic thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Aorto-duodenal fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Arteriovenous fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Deep vein thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    10 / 6988 (0.14%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic vascular disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Essential hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extremity necrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery embolism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hot flush
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    18 / 6996 (0.26%)
    8 / 6988 (0.11%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive crisis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    12 / 6996 (0.17%)
    10 / 6988 (0.14%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypotension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    10 / 6988 (0.14%)
    9 / 6958 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothenar hammer syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemic shock
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iliac artery occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leriche syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphoedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malignant hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Penetrating atherosclerotic ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 6996 (0.21%)
    17 / 6988 (0.24%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 17
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    17 / 6996 (0.24%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral circulatory failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Peripheral embolism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poor peripheral circulation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Steal syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subclavian artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Superior vena cava syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Temporal arteritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Vena cava thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous insufficiency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac death
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Catheter site haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest discomfort
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    6 / 6988 (0.09%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    42 / 6996 (0.60%)
    42 / 6988 (0.60%)
    34 / 6958 (0.49%)
         occurrences causally related to treatment / all
    0 / 42
    2 / 42
    3 / 34
         deaths causally related to treatment / all
    0 / 42
    2 / 42
    3 / 34
    Device battery issue
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device breakage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device defective
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device lead damage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device lead issue
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device malfunction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Device material issue
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drowning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Drug withdrawal syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Euthanasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Fatigue
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gait disturbance
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hernia obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothermia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired healing
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Implant site pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injection site bruising
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaise
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Medical device complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Non-cardiac chest pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    109 / 6996 (1.56%)
    115 / 6988 (1.65%)
    113 / 6958 (1.62%)
         occurrences causally related to treatment / all
    0 / 118
    3 / 122
    1 / 124
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stent-graft endoleak
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    33 / 6996 (0.47%)
    27 / 6988 (0.39%)
    27 / 6958 (0.39%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 27
    0 / 27
         deaths causally related to treatment / all
    0 / 33
    0 / 27
    0 / 27
    Sudden death
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    6 / 6988 (0.09%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    1 / 9
    0 / 6
    0 / 11
    Systemic inflammatory response syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vessel puncture site haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic shock
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anti-neutrophil cytoplasmic antibody positive vasculitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contrast media allergy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reaction to food additive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sarcoidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired phimosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    26 / 6996 (0.37%)
    20 / 6988 (0.29%)
    25 / 6958 (0.36%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 20
    2 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast fibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus prostatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical dysplasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystocele
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endometrial hyperplasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gynaecomastia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Menorrhagia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metrorrhagia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ovarian necrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatic mass
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uterovaginal prolapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicocele
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Acute respiratory distress syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Acute respiratory failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    6 / 6988 (0.09%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
    Aspiration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Asthma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    9 / 6988 (0.13%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Atelectasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Choking
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    45 / 6996 (0.64%)
    54 / 6988 (0.77%)
    39 / 6958 (0.56%)
         occurrences causally related to treatment / all
    0 / 65
    1 / 74
    1 / 62
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    0 / 2
    Chronic respiratory failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cough
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic paralysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diffuse panbronchiolitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    12 / 6996 (0.17%)
    29 / 6988 (0.41%)
    23 / 6958 (0.33%)
         occurrences causally related to treatment / all
    1 / 12
    11 / 30
    8 / 24
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Dyspnoea exertional
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emphysema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottic cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottic oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    20 / 6988 (0.29%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    1 / 2
    16 / 21
    12 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    5 / 6
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrothorax
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Laryngeal oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung consolidation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal polyps
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nocturnal dyspnoea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive airways disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Organising pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural adhesion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    16 / 6996 (0.23%)
    2 / 6988 (0.03%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pleurisy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    5 / 6988 (0.07%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pneumothorax
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax spontaneous
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    17 / 6996 (0.24%)
    21 / 6988 (0.30%)
    17 / 6958 (0.24%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 23
    0 / 17
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
    Pulmonary fibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Pulmonary haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary mass
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
    Respiratory arrest
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    1 / 3
    0 / 2
    0 / 3
    Respiratory tract haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract inflammation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sleep apnoea syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    3 / 6988 (0.04%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillar hypertrophy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vocal cord leukoplakia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol abuse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcoholism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anxiety
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bipolar I disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    1 / 3
    0 / 0
    Confusional state
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conversion disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Delirium
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depressed mood
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Depression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    11 / 6988 (0.16%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Insomnia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Major depression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panic attack
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panic disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic stress disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric decompensation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric symptom
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychotic behaviour
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somatoform disorder cardiovascular
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Blood electrolytes decreased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood glucose decreased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood urine present
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac stress test abnormal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium test positive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ejection fraction decreased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrocardiogram abnormal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematocrit decreased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymph node palpable
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Occult blood positive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scan myocardial perfusion abnormal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Weight increased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Accidental overdose
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia postoperative
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaesthetic complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anastomotic ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ankle fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arterial restenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropod sting
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone contusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone fissure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain contusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Brain herniation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Burns second degree
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns third degree
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Carbon monoxide poisoning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery restenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical vertebral fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Chemical peritonitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Cystitis radiation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Face injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fall
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral neck fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    4 / 6988 (0.06%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    11 / 6988 (0.16%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fractured ischium
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gas poisoning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria traumatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Heat exhaustion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heat stroke
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hip fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    5 / 6988 (0.07%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Humerus fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia, obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inflammation of wound
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal anastomosis complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint capsule rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ligament sprain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb traumatic amputation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lip injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    5 / 6988 (0.07%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle strain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoradionecrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Overdose
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pancreatic leak
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Patella fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial reocclusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery restenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periprosthetic fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumothorax traumatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Poisoning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post gastric surgery syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haematuria
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    11 / 6988 (0.16%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    4 / 12
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural persistent drain fluid
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post-traumatic pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative ileus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative respiratory failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    6 / 6988 (0.09%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 7
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Procedural hypotension
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary contusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radial nerve injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiation dysphagia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Remnant gastritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rib fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    8 / 6988 (0.11%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Scapula fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seroma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Soft tissue injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 5
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Suture related complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    6 / 6988 (0.09%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    13 / 6988 (0.19%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    5 / 14
    2 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic haemothorax
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    11 / 6996 (0.16%)
    18 / 6988 (0.26%)
    17 / 6958 (0.24%)
         occurrences causally related to treatment / all
    0 / 13
    2 / 20
    4 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
    Traumatic spinal cord compression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ulna fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention postoperative
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VIIIth nerve injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular graft thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular procedure complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Venous injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Acute left ventricular failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
    Acute myocardial infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    28 / 6996 (0.40%)
    19 / 6988 (0.27%)
    20 / 6958 (0.29%)
         occurrences causally related to treatment / all
    0 / 28
    1 / 19
    1 / 20
         deaths causally related to treatment / all
    0 / 26
    1 / 17
    1 / 17
    Adams-Stokes syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina pectoris
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    51 / 6996 (0.73%)
    51 / 6988 (0.73%)
    45 / 6958 (0.65%)
         occurrences causally related to treatment / all
    1 / 53
    0 / 55
    0 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Aortic valve disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    Arrhythmia supraventricular
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Atrial fibrillation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    67 / 6996 (0.96%)
    74 / 6988 (1.06%)
    94 / 6958 (1.35%)
         occurrences causally related to treatment / all
    0 / 73
    0 / 88
    0 / 104
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial flutter
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    16 / 6996 (0.23%)
    13 / 6988 (0.19%)
    14 / 6958 (0.20%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 13
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial tachycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Atrioventricular block complete
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    13 / 6996 (0.19%)
    3 / 6988 (0.04%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    2 / 14
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    1 / 5
    2 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bifascicular block
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    7 / 6988 (0.10%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block left
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bundle branch block right
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    7 / 6988 (0.10%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    1 / 4
    0 / 5
    0 / 5
    Cardiac asthma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    58 / 6996 (0.83%)
    54 / 6988 (0.77%)
    53 / 6958 (0.76%)
         occurrences causally related to treatment / all
    0 / 73
    1 / 69
    0 / 70
         deaths causally related to treatment / all
    0 / 13
    0 / 4
    0 / 7
    Cardiac failure acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    4 / 6988 (0.06%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    0 / 1
    0 / 3
    Cardiac failure chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    14 / 6996 (0.20%)
    19 / 6988 (0.27%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 25
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
    Cardiac failure congestive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    51 / 6996 (0.73%)
    70 / 6988 (1.00%)
    53 / 6958 (0.76%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 97
    0 / 79
         deaths causally related to treatment / all
    0 / 2
    0 / 14
    0 / 5
    Cardiac hypertrophy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac tamponade
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac valve disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    6 / 6988 (0.09%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    0 / 5
    0 / 6
    Cardiogenic shock
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    4 / 6988 (0.06%)
    9 / 6958 (0.13%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    0 / 8
    Cardiomyopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cardiopulmonary failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Cardiovascular insufficiency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
    Conduction disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cor pulmonale chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    6 / 6988 (0.09%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Coronary artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coronary artery thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Dressler's syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrocardiac syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracardiac thrombus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    8 / 6988 (0.11%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Left ventricular dysfunction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Left ventricular failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
    Low cardiac output syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve calcification
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve incompetence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mitral valve prolapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial fibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    11 / 6996 (0.16%)
    10 / 6988 (0.14%)
    9 / 6958 (0.13%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 11
    0 / 10
    0 / 9
    Myocardial ischaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Myocardial oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myocardial rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Myocarditis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal arrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nodal rhythm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Palpitations
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericardial haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pericarditis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulseless electrical activity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Right ventricular failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sick sinus syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    8 / 6988 (0.11%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 9
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinoatrial block
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus arrest
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus arrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus bradycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    12 / 6988 (0.17%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    4 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subendocardial ischaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular extrasystoles
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systolic dysfunction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tachycardia paroxysmal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ventricular dysfunction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    3 / 6988 (0.04%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    4 / 6988 (0.06%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 5
    Ventricular tachycardia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    12 / 6996 (0.17%)
    17 / 6988 (0.24%)
    17 / 6958 (0.24%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 20
    1 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Nervous system disorders
    Amyotrophic lateral sclerosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Brain oedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Brain stem infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Brain stem syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid arteriosclerosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    15 / 6988 (0.21%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 17
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carotid sinus syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cauda equina syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebellar ataxia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Cerebral cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
    Cerebral infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Cerebral ischaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral microangiopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    Cerebrovascular disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical cord compression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical myelopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical radiculopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cluster headache
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Complex regional pain syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dementia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Dementia Alzheimer's type
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Demyelinating polyneuropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic neuropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dizziness
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    9 / 6988 (0.13%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 10
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extrapyramidal disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Grand mal convulsion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage intracranial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    Haemorrhagic stroke
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    6 / 10
    1 / 5
    2 / 3
         deaths causally related to treatment / all
    3 / 6
    0 / 3
    1 / 1
    Haemorrhagic transformation stroke
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Headache
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercapnic coma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    IIIrd nerve paralysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ischaemic stroke
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    18 / 6996 (0.26%)
    11 / 6988 (0.16%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 11
    1 / 11
         deaths causally related to treatment / all
    0 / 12
    0 / 8
    1 / 9
    Leukoencephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar radiculopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Migraine
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mononeuritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Monoparesis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple sclerosis relapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Muscle contractions involuntary
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myelopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myoclonus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nerve root compression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuritis cranial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Occipital neuralgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orthostatic intolerance
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraesthesia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinson's disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peripheral nerve paresis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presyncope
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    3 / 6988 (0.04%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychomotor hyperactivity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Quadriparesis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Radiculopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Sciatica
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Senile dementia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Serotonin syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Somnolence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal cord compression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Subarachnoid haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Syncope
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    28 / 6996 (0.40%)
    37 / 6988 (0.53%)
    31 / 6958 (0.45%)
         occurrences causally related to treatment / all
    0 / 30
    3 / 39
    1 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Temporal lobe epilepsy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tension headache
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient global amnesia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Uraemic encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VIIth nerve paralysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    VIth nerve paresis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vagus nerve disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular parkinsonism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebral artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    12 / 6988 (0.17%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    5 / 12
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia macrocytic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia megaloblastic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia of chronic disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia of malignant disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aplastic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulation factor deficiency
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile neutropenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 4
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercoagulation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Increased tendency to bruise
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    24 / 6988 (0.34%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    2 / 3
    10 / 25
    3 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    4 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrogenic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pernicious anaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenic haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Splenomegaly
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spontaneous haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spontaneous haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    8 / 6988 (0.11%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    5 / 8
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Auricular perichondritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deafness
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Deafness unilateral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inner ear disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniere's disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Middle ear effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Presbyacusis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sudden hearing loss
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tympanic membrane perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo labyrinthine
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Age-related macular degeneration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angle closure glaucoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blindness unilateral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    14 / 6996 (0.20%)
    10 / 6988 (0.14%)
    16 / 6958 (0.23%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cataract nuclear
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctival haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic retinopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diplopia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine ophthalmopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extraocular muscle paresis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eyelid ptosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular degeneration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Macular fibrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Open angle glaucoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Opsoclonus myoclonus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pterygium
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal artery embolism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal artery occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal degeneration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retinal vein occlusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Strabismus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tolosa-Hunt syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal discomfort
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    7 / 6988 (0.10%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain lower
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall haematoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute abdomen
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    Anal fissure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal polyp
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendiceal mucocoele
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ascites
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Barrett's oesophagus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    9 / 6988 (0.13%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Crohn's disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dental caries
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    7 / 6988 (0.10%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dieulafoy's vascular malformation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticular perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Diverticulitis intestinal haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    3 / 5
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    8 / 6988 (0.11%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 9
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    11 / 6988 (0.16%)
    12 / 6958 (0.17%)
         occurrences causally related to treatment / all
    1 / 2
    8 / 12
    12 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 5
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    7 / 6988 (0.10%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    3 / 4
    5 / 7
    5 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Duodenitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dyspepsia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dysphagia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erosive duodenitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erosive oesophagitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Faecalith
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femoral hernia, obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Food poisoning
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric polyps
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    13 / 6988 (0.19%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    2 / 4
    6 / 14
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    18 / 6988 (0.26%)
    14 / 6958 (0.20%)
         occurrences causally related to treatment / all
    4 / 7
    13 / 18
    9 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Gastritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    17 / 6988 (0.24%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    1 / 11
    3 / 18
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis atrophic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis erosive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis hypertrophic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroduodenitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal erosion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    26 / 6988 (0.37%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    7 / 9
    13 / 27
    12 / 15
         deaths causally related to treatment / all
    1 / 2
    0 / 4
    1 / 1
    Gastrointestinal mucosal disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal necrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    5 / 6988 (0.07%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    10 / 6996 (0.14%)
    11 / 6988 (0.16%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gingival bleeding
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematemesis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ileus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    4 / 6988 (0.06%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Ileus paralytic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Impaired gastric emptying
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 12
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    21 / 6996 (0.30%)
    25 / 6988 (0.36%)
    26 / 6958 (0.37%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 25
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal infarction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Intestinal ischaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    Intestinal obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Intestinal perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Intussusception
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Irritable bowel syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestinal ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine polyp
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    12 / 6988 (0.17%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mechanical ileus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Melaena
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    3 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nausea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal achalasia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophageal varices haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic duct obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic mass
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    7 / 6988 (0.10%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Pancreatitis acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    8 / 6988 (0.11%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Papilla of Vater stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotid gland inflammation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    2 / 4
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    5 / 6988 (0.07%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 5
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal polyp
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reflux gastritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small intestinal perforation
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tongue blistering
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tooth disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toothache
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    7 / 6988 (0.10%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 7
    5 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
    Volvulus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Volvulus of small bowel
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    1 / 6988 (0.01%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 1
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary dyskinesia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biloma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholangitis sclerosing
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    10 / 6988 (0.14%)
    17 / 6958 (0.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    11 / 6996 (0.16%)
    7 / 6988 (0.10%)
    11 / 6958 (0.16%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    31 / 6996 (0.44%)
    15 / 6988 (0.21%)
    18 / 6958 (0.26%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 15
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholestasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chronic hepatitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cirrhosis alcoholic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug-induced liver injury
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gallbladder disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic cirrhosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hepatic vein thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Hepatomegaly
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatorenal failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydrocholecystis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperplastic cholecystopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaundice cholestatic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Portal vein thrombosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Angioedema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cutaneous sarcoidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermal cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug eruption
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dry gangrene
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ecchymosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eczema
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperhidrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkeratosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity vasculitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Panniculitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyoderma gangrenosum
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash generalised
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stevens-Johnson syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder diverticulum
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder neck sclerosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bladder tamponade
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus bladder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus ureteric
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urethral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Calculus urinary
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis haemorrhagic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis noninfective
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis membranoproliferative
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis membranous
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematuria
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    9 / 6988 (0.13%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 9
    9 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemorrhage urinary tract
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypertensive nephropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    21 / 6988 (0.30%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    2 / 22
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obstructive uropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvi-ureteric obstruction
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal artery stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal colic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal cyst ruptured
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal failure
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 6996 (0.21%)
    6 / 6988 (0.09%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 2
    Renal failure acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    28 / 6996 (0.40%)
    32 / 6988 (0.46%)
    32 / 6958 (0.46%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 34
    1 / 32
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
    Renal failure chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    1 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Renal haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal tubular acidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureteric rupture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Ureteric stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder polyp
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary retention
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    1 / 6988 (0.01%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinoma
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Goitre
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic nodular goitre
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    10 / 6988 (0.14%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Back pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    8 / 6988 (0.11%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bone pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Costochondritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dupuytren's contracture
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Facet joint syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fibromyalgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture malunion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Fracture nonunion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemarthrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand deformity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc compression
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc degeneration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    14 / 6996 (0.20%)
    8 / 6988 (0.11%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Jaw disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint ankylosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mobility decreased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Monarthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle haemorrhage
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle hypertrophy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal chest pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    20 / 6996 (0.29%)
    16 / 6988 (0.23%)
    22 / 6958 (0.32%)
         occurrences causally related to treatment / all
    1 / 20
    0 / 17
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myalgia intercostal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myopathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myositis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neck pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    59 / 6996 (0.84%)
    54 / 6988 (0.77%)
    54 / 6958 (0.78%)
         occurrences causally related to treatment / all
    0 / 62
    0 / 57
    0 / 59
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pain in jaw
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periarthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polyarthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psoriatic arthropathy
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Resorption bone increased
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rheumatoid arthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    12 / 6988 (0.17%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sacroiliitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    9 / 6958 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    7 / 6988 (0.10%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Spondylolysis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sympathetic posterior cervical syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon calcification
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendon disorder
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Abdominal sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Abdominal wall abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abdominal wall infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess limb
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acquired immunodeficiency syndrome
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    9 / 6996 (0.13%)
    7 / 6988 (0.10%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Avian influenza
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial prostatitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacterial pyelonephritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bartholin's abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Biliary sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Breast abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    19 / 6996 (0.27%)
    22 / 6988 (0.31%)
    10 / 6958 (0.14%)
         occurrences causally related to treatment / all
    1 / 20
    1 / 27
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    12 / 6988 (0.17%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    Bronchopulmonary aspergillosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bursitis infective
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    14 / 6996 (0.20%)
    12 / 6988 (0.17%)
    17 / 6958 (0.24%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 13
    1 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis laryngeal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis of male external genital organ
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cerebral toxoplasmosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Chest wall abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholangitis suppurative
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cholecystitis infective
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic sinusitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium colitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Clostridium difficile infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Colonic abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Congo-Crimean haemorrhagic fever
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    2 / 6988 (0.03%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Device related sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic gangrene
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    12 / 6996 (0.17%)
    11 / 6988 (0.16%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 12
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    Ear infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emphysematous cholecystitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis brain stem
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Endocarditis bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enteritis infectious
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterocolitis infectious
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epiglottitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    7 / 6996 (0.10%)
    4 / 6988 (0.06%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia bacteraemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia pyelonephritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Extradural abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Eye infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Furuncle
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gangrene
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    5 / 6988 (0.07%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    Gastritis viral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    18 / 6996 (0.26%)
    18 / 6988 (0.26%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 18
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gingivitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    H1N1 influenza
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter gastritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatitis viral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex meningoencephalitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Incision site infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infected fistula
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Infected skin ulcer
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    4 / 6988 (0.06%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Infectious colitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious pleural effusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    2 / 6988 (0.03%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intervertebral discitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Labyrinthitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leishmaniasis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Listeria sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Localised infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lower respiratory tract infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    4 / 6988 (0.06%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    Lower respiratory tract infection bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lung infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Lyme disease
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malaria
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Muscle abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Myringitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Ophthalmic herpes zoster
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Orchitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    5 / 6988 (0.07%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis externa
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media chronic
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Paraspinal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Parotitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pelvic abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    Peritonsillar abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngeal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pilonidal cyst
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    Pneumocystis jirovecii pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    76 / 6996 (1.09%)
    77 / 6988 (1.10%)
    69 / 6958 (0.99%)
         occurrences causally related to treatment / all
    1 / 83
    0 / 86
    1 / 72
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    1 / 10
    Pneumonia bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    11 / 6996 (0.16%)
    6 / 6988 (0.09%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
    Pneumonia cytomegaloviral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia haemophilus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia influenzal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia legionella
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia necrotising
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pneumococcal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia pseudomonal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia streptococcal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Post procedural pneumonia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    8 / 6958 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Proctitis infectious
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonal sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudomonas infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pulmonary sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Pulmonary tuberculosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    4 / 6988 (0.06%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyopneumothorax
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    4 / 6996 (0.06%)
    4 / 6988 (0.06%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Salmonellosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Scrotal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 6996 (0.21%)
    17 / 6988 (0.24%)
    20 / 6958 (0.29%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 18
    0 / 20
         deaths causally related to treatment / all
    0 / 3
    0 / 8
    0 / 5
    Septic necrosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Septic shock
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    6 / 6996 (0.09%)
    12 / 6988 (0.17%)
    7 / 6958 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    0 / 3
    Sialoadenitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    4 / 6988 (0.06%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Streptococcal infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subacute endocarditis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxoplasmosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tracheobronchitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urethritis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary bladder abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    15 / 6996 (0.21%)
    28 / 6988 (0.40%)
    27 / 6958 (0.39%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 30
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    19 / 6988 (0.27%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 19
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    Vestibular neuronitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral diarrhoea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound abscess
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    3 / 6996 (0.04%)
    6 / 6988 (0.09%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection bacterial
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection staphylococcal
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Yersinia infection
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Abnormal loss of weight
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Decreased appetite
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    8 / 6996 (0.11%)
    11 / 6988 (0.16%)
    9 / 6958 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    13 / 6996 (0.19%)
    15 / 6988 (0.21%)
    15 / 6958 (0.22%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 17
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    13 / 6996 (0.19%)
    11 / 6988 (0.16%)
    12 / 6958 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diabetic complication
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Diabetic ketoacidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Failure to thrive
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gout
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypercalcaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    5 / 6988 (0.07%)
    4 / 6958 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    3 / 6988 (0.04%)
    5 / 6958 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Hypocalcaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    5 / 6988 (0.07%)
    6 / 6958 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypomagnesaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    3 / 6988 (0.04%)
    2 / 6958 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lactose intolerance
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    0 / 6988 (0.00%)
    1 / 6958 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    2 / 6996 (0.03%)
    2 / 6988 (0.03%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Obesity
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    1 / 6996 (0.01%)
    0 / 6988 (0.00%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    0 / 6996 (0.00%)
    1 / 6988 (0.01%)
    0 / 6958 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    5 / 6996 (0.07%)
    6 / 6988 (0.09%)
    3 / 6958 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Ticagrelor 90mg bd Ticagrelor 60mg bd
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    945 / 6996 (13.51%)
    2245 / 6988 (32.13%)
    1992 / 6958 (28.63%)
    Injury, poisoning and procedural complications
    Contusion
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    111 / 6996 (1.59%)
    385 / 6988 (5.51%)
    353 / 6958 (5.07%)
         occurrences all number
    122
    473
    471
    Blood and lymphatic system disorders
    Increased tendency to bruise
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    65 / 6996 (0.93%)
    464 / 6988 (6.64%)
    419 / 6958 (6.02%)
         occurrences all number
    70
    575
    520
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    329 / 6996 (4.70%)
    1091 / 6988 (15.61%)
    876 / 6958 (12.59%)
         occurrences all number
    362
    1340
    1036
    Epistaxis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    165 / 6996 (2.36%)
    505 / 6988 (7.23%)
    420 / 6958 (6.04%)
         occurrences all number
    221
    668
    623
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 17
         subjects affected / exposed
    377 / 6996 (5.39%)
    368 / 6988 (5.27%)
    364 / 6958 (5.23%)
         occurrences all number
    469
    490
    486

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2011
    The primary reason for the global amendment was to stop patients with history of prior ischaemic stroke from receiving study drug as there was, at the time of the amendment, growing data from studies of other antiplatelet drugs (none of them ticagrelor) suggesting that more intensive antiplatelet therapy might pose high risk of intracranial haemorrhage (ICH) in patients with a history of ischaemic stroke (Morrow et al 2013, Wiviott et al 2007). While there are no data that ticagrelor predisposes patients with prior ischaemic stroke to intracranial haemorrhage, it was considered prudent going forward to exclude patients with prior stroke from the study so as not to potentially complicate the interpretation of the results. Previously randomised stroke patients continued to be followed up off treatment. This study was neither intended nor powered to answer specific safety questions relating to small subgroups such as those patients with prior ischaemic stroke. This action, to exclude patients with prior stroke from this study, should not be interpreted to restrict any future investigation of ticagrelor in patients with prior stroke for this or for other potential indications. Indeed, AstraZeneca is conducting a trial of ticagrelor in acute stroke patients (IND115, 807, D5134C00001). In addition to excluding patients with history of stroke, the amendment also broadened the prior exclusion to also exclude patients with a history of a central nervous system tumour on intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time, or intracranial or spinal cord surgery within 5 years, because these are conditions that are associated with an increased risk of intracranial/intraspinal haemorrhage.

    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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