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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, Carer, Data analyst, 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