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    Clinical Trial Results:
    A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia (STRENGTH)

    Summary
    EudraCT number
    		 2014-001069-28
    Trial protocol
    		 CZ   GB   EE   LT   HU   IT   DK   NL   PL   BE  
    Global end of trial date
    27 May 2020

    Results information
    Results version number
    		 v2(current)
    This version publication date
    26 Sep 2021
    First version publication date
    10 Jun 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    We revised FSR date.

    Trial information

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    Trial identification
    Sponsor protocol code
    D5881C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    AstraZenenca Information Center, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 18772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jul 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the effectiveness of adding Epanova to statin therapy (with or without ezetimibe) for lowering MACE (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina) in high cardiovascular risk patients with persistent hypertriglyceridemia and low high-density lipoprotein cholesterol.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/GCP, applicable regulatory requirements, and the AstraZeneca policy on Bioethics and Human Biological Smaples.
    Background therapy
    		 Background statin therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Oct 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 112
    Country: Number of subjects enrolled
    Belgium: 104
    Country: Number of subjects enrolled
    Canada: 364
    Country: Number of subjects enrolled
    Czechia: 228
    Country: Number of subjects enrolled
    Denmark: 121
    Country: Number of subjects enrolled
    Estonia: 110
    Country: Number of subjects enrolled
    Hungary: 1123
    Country: Number of subjects enrolled
    Italy: 67
    Country: Number of subjects enrolled
    Japan: 305
    Country: Number of subjects enrolled
    Lithuania: 363
    Country: Number of subjects enrolled
    Mexico: 307
    Country: Number of subjects enrolled
    Netherlands: 421
    Country: Number of subjects enrolled
    New Zealand: 151
    Country: Number of subjects enrolled
    Poland: 993
    Country: Number of subjects enrolled
    Russian Federation: 633
    Country: Number of subjects enrolled
    South Africa: 961
    Country: Number of subjects enrolled
    Korea, Republic of: 133
    Country: Number of subjects enrolled
    Taiwan: 59
    Country: Number of subjects enrolled
    Ukraine: 1964
    Country: Number of subjects enrolled
    United Kingdom: 759
    Country: Number of subjects enrolled
    United States: 3087
    Country: Number of subjects enrolled
    China: 713
    Worldwide total number of subjects
    13078
    EEA total number of subjects
    3530
    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)
    7459
    From 65 to 84 years
    5563
    85 years and over
    56

    Subject disposition

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    Recruitment
    Recruitment details
    		 686 study sites in 22 countries randomized subjects. The first patient was randomized on 11 November 2014. The last patient was randomized on 12 July 2017.

    Pre-assignment
    Screening details
    		 In total, 33047 patients were enrolled, with 13078 patients randomized ( 6539 patients were randomized to Epanova and 6539 to placebo). Among the randomized patients, 7 in the Epanova group and 4 in the placebo group did not receive study treatment.

    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
    		 Epanova
    Arm description
    		 Omega-3 carboxylic acid 4 x 1 gram capsule
    Arm type
    		 Experimental

    Investigational medicinal product name
    Omega-3 carboxylic acid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1 gram capsule orally once daily

    Arm title
    		 Placebo
    Arm description
    		 Corn oil 4 x 1 gram capsule
    Arm type
    		 Placebo

    Investigational medicinal product name
    corn oil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    4 x 1 gram capsule orally once daily

    Number of subjects in period 1
    		Epanova Placebo
    Started
    6539
    6539
    Completed
    80
    92
    Not completed
    6459
    6447
         Adverse event, serious fatal
    363
    330
         Consent withdrawn by subject
    111
    78
         Study terminated by sponsor
    5854
    5901
         Other reasons
    128
    135
         Lost to follow-up
    3
    2
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 Omega-3 carboxylic acid 4 x 1 gram capsule

    Reporting group title
    Placebo
    Reporting group description
    		 Corn oil 4 x 1 gram capsule

    Reporting group values
    		 Epanova Placebo Total
    Number of subjects
    		 6539 6539 13078
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 3756 3703 7459
        From 65-84 years
    		 2758 2805 5563
        85 years and over
    		 25 31 56
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.5 ( 8.98 ) 62.5 ( 8.98 ) -
    Sex: Female, Male
    Units: Participants
        Male
    		 4250 4260 8510
        Female
    		 2289 2279 4568
    Race (NIH/OMB)
    Units: Subjects
        WHITE
    		 5341 5382 10723
        BLACK OR AFRICAN AMERICAN
    		 180 166 346
        ASIAN
    		 698 657 1355
        NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
    		 10 11 21
        AMERICAN INDIAN OR ALASKA NATIVE
    		 114 112 226
        OTHER
    		 159 154 313
        MULTIPLE
    		 33 47 80
        UNKNOWN
    		 4 10 14
        NOT REPORTED
    		 0 0 0
    Region of Enrollment
    Units: Subjects
        Australia
    		 58 54 112
        Belgium
    		 53 51 104
        Canada
    		 187 177 364
        China
    		 357 356 713
        Czech Republic
    		 120 108 228
        Denmark
    		 48 73 121
        Estonia
    		 57 53 110
        Hungary
    		 561 562 1123
        Italy
    		 33 34 67
        Japan
    		 166 139 305
        Korea, Republic Of
    		 68 65 133
        Lithuania
    		 170 193 363
        Mexico
    		 152 155 307
        Netherlands
    		 206 215 421
        New Zealand
    		 74 77 151
        Poland
    		 501 492 993
        Russia
    		 307 326 633
        South Africa
    		 471 490 961
        Taiwan, Province Of China
    		 28 31 59
        Ukraine
    		 1009 955 1964
        United Kingdom
    		 377 382 759
        USA
    		 1536 1551 3087

    End points

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    End points reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 Omega-3 carboxylic acid 4 x 1 gram capsule

    Reporting group title
    Placebo
    Reporting group description
    		 Corn oil 4 x 1 gram capsule

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set contains all subjects who were randomised

    Subject analysis set title
    Safety analysis set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety analysis set contains all randomised subjects who received at least 1 dose of investigational product

    Primary: The primary outcome measure is the time to the first occurrence of any component of the composite of Major adverse cardiovascular events (MACE)

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    End point title
    		 The primary outcome measure is the time to the first occurrence of any component of the composite of Major adverse cardiovascular events (MACE)
    End point description
    MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina.
    End point type
    Primary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
    785
    795
    Statistical analysis title
    		 Primary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Placebo v Epanova
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.837 [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.09
    Notes
    [1] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Secondary: Time to the first occurrence of the composite measure of MACE in participants with established CV disease(CVD) at baseline

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    End point title
    		 Time to the first occurrence of the composite measure of MACE in participants with established CV disease(CVD) at baseline
    End point description
    Time to the first occurrence of the composite measure of MACE that includes the first occurrence of CV death, non-fatal MI, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina in the subgroup of participants with established CVD at baseline
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    785
    795
        # of participants with events with CVD at baseline
    569
    610
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), region and treatment by established CVD at baseline interaction
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.269 [2]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.05
    Notes
    [2] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Secondary: Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke

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    End point title
    		 Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke
    End point description
    Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
    541
    517
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.402 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.19
    Notes
    [3] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing

    Secondary: Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke in the subgroup of participants with established CVD at baseline

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    End point title
    		 Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke in the subgroup of participants with established CVD at baseline
    End point description
    Time to the first occurrence of the composite measure of CV events that include the first occurrence of CV death, non-fatal MI and non-fatal stroke in the subgroup of participants with established CVD at baseline
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    541
    517
        # of participants with events with CVD at baseline
    383
    385
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), region and treatment by established CVD at baseline interaction
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.94 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.16
    Notes
    [4] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing

    Secondary: Time to the first occurrence of the composite measure of coronary events that include the first occurrence of cardiac death, non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina

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    End point title
    		 Time to the first occurrence of the composite measure of coronary events that include the first occurrence of cardiac death, non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina
    End point description
    Time to the first occurrence of the composite measure of coronary events that include the first occurrence of cardiac death (including death due to acute MI, sudden cardiac death and death due to CV procedure), non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
    556
    616
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.092 [5]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.02
    Notes
    [5] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing

    Secondary: Time to 1st occurrence of a composite measure of coronary events (includes cardiac death, non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina) in the subgroup of participants with established CVD at baseline

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    End point title
    		 Time to 1st occurrence of a composite measure of coronary events (includes cardiac death, non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina) in the subgroup of participants with established CVD at baseline
    End point description
    Time to the first occurrence of the composite measure of coronary events that include the first occurrence of cardiac death (including death due to acute MI, sudden cardiac death and death due to CV procedures), non-fatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina in the subgroup of participants with established CVD at baseline
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    556
    616
        # of participants with events with CVD at baseline
    417
    493
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), region and treatment by established CVD at baseline interaction
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.016 [6]
    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
    		 0.97
    Notes
    [6] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Secondary: Time to the first occurrence of CV death

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    End point title
    		 Time to the first occurrence of CV death
    End point description
    The time to the first occurrence of CV death
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
    228
    211
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.372 [7]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.31
    Notes
    [7] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing

    Secondary: The time to first occurrence of CV death in the subgroup of participants with established CVD at baseline

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    End point title
    		 The time to first occurrence of CV death in the subgroup of participants with established CVD at baseline
    End point description
    The time to the first occurrence of CV death in the subgroup of participants with established CVD at baseline
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    228
    211
        # of participants with events with CVD at baseline
    152
    138
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), region and treatment by established CVD at baseline interaction
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.336 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.41
    Notes
    [8] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Secondary: Time to the first occurrence of all-cause death

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    End point title
    		 Time to the first occurrence of all-cause death
    End point description
    Time to the first occurrence of death from any cause.
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
    373
    333
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.112 [9]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.31
    Notes
    [9] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Secondary: Time to the first occurrence of all-cause death in the subgroup of participants with established CVD at baseline

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    End point title
    		 Time to the first occurrence of all-cause death in the subgroup of participants with established CVD at baseline
    End point description
    Time to the first occurrence of death of any cause in the subgroup of participants with established CVD at baseline
    End point type
    Secondary
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    373
    333
        # of participants with events with CVD at baseline
    234
    202
    Statistical analysis title
    		 Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), region and treatment by established CVD at baseline interaction
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.091 [10]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.42
    Notes
    [10] - The hypothesis is tested at the 5% level. A hierarchical test sequence is used to address the issue of multiple testing.

    Other pre-specified: Time to emergent/elective coronary revascularization

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    End point title
    		 Time to emergent/elective coronary revascularization
    End point description
    Time to emergent/elective coronary revascularization
    End point type
    Other pre-specified
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    414
    441
    Statistical analysis title
    		 Other Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.408 [11]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.08
    Notes
    [11] - This endpoint was not in the testing sequence and therefore not under type I error control.

    Other pre-specified: Time to hospitalization for unstable angina

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    End point title
    		 Time to hospitalization for unstable angina
    End point description
    Time to hospitalization for unstable angina
    End point type
    Other pre-specified
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    87
    104
    Statistical analysis title
    		 Other Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.233 [12]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.12
    Notes
    [12] - This endpoint was not in the testing sequence and therefore not under type I error control.

    Other pre-specified: Time to non-fatal myocardial infarction

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    End point title
    		 Time to non-fatal myocardial infarction
    End point description
    Time to non-fatal myocardial infarction
    End point type
    Other pre-specified
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    218
    226
    Statistical analysis title
    		 Other Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.77 [13]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.17
    Notes
    [13] - This endpoint was not in the testing sequence and therefore not under type I error control.

    Other pre-specified: Time to non-fatal stroke

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    End point title
    		 Time to non-fatal stroke
    End point description
    Time to non-fatal stoke
    End point type
    Other pre-specified
    End point timeframe
    From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
    End point values
    		 Epanova Placebo
    Number of subjects analysed
    6539
    6539
    Units: Participants
        Number of participants with events
    142
    125
    Statistical analysis title
    		 Other Secondary Endpoint Analysis
    Statistical analysis description
    Cox proportional hazards model of time from randomization to the first event as a function of treatment, established CVD at baseline (yes vs. no), and region
    Comparison groups
    Epanova v Placebo
    Number of subjects included in analysis
    13078
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.278 [14]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.45
    Notes
    [14] - This endpoint was not in the testing sequence and therefore not under type I error control.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events will be recorded at all visits for the patients who prematurely discontinue IP. Non Serious Adverse Events will be collected until the final visit but no more than 30 days after the last dose of IP.
    Adverse event reporting additional description
    Only Adverse Events that are considered serious, lead to discontinuation of IP or result in a dose modification, overdose, new onset of diabetes mellitus, TIA, PHL cases or bleeding related events will be captured starting after randomization through the final visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Epanova
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Epanova Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2259 / 6532 (34.58%)
    2195 / 6535 (33.59%)
         number of deaths (all causes)
    371
    333
         number of deaths resulting from adverse events
    334
    299
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acoustic neuroma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Acute promyelocytic leukaemia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    3 / 6532 (0.05%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    4 / 6532 (0.06%)
    6 / 6535 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    4 / 6532 (0.06%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adrenal adenoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiomyolipoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anogenital warts
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell prolymphocytic leukaemia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    15 / 6532 (0.23%)
    17 / 6535 (0.26%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign bone neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of eyelid
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign pancreatic neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cancer
         subjects affected / exposed
    9 / 6532 (0.14%)
    9 / 6535 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer recurrent
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    3 / 6532 (0.05%)
    6 / 6535 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder squamous cell carcinoma stage unspecified
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    8 / 6532 (0.12%)
    17 / 6535 (0.26%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Breast cancer female
         subjects affected / exposed
    3 / 6532 (0.05%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Bronchioloalveolar carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac neoplasm malignant
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Castleman's disease
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    10 / 6532 (0.15%)
    20 / 6535 (0.31%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    Colon cancer metastatic
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Colon cancer stage 0
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    5 / 6532 (0.08%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Craniopharyngioma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential thrombocythaemia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female reproductive neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric adenoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    3 / 6532 (0.05%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastrointestinal carcinoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of bone
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head and neck cancer metastatic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    3 / 6532 (0.05%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Hepatic neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    4 / 6532 (0.06%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Intestinal adenocarcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papilloma of breast
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    4 / 6532 (0.06%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratinising squamous cell carcinoma of nasopharynx
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lentigo maligna
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    7 / 6532 (0.11%)
    9 / 6535 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Lung adenocarcinoma recurrent
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    3 / 6532 (0.05%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    8 / 6532 (0.12%)
    12 / 6535 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    Lymphoma
         subjects affected / exposed
    4 / 6532 (0.06%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    11 / 6532 (0.17%)
    7 / 6535 (0.11%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant neoplasm of eye
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of renal pelvis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of spinal cord
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant polyp
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mantle cell lymphoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    3 / 6532 (0.05%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastases to lung
         subjects affected / exposed
    4 / 6532 (0.06%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to pleura
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to rectum
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to soft tissue
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastasis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic uterine cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mucoepidermoid carcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm malignant
         subjects affected / exposed
    4 / 6532 (0.06%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Neoplasm of appendix
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm prostate
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm skin
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodular melanoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    6 / 6532 (0.09%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    Oesophageal papilloma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ovarian adenoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian endometrioid carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian granulosa cell tumour
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paget's disease of the vulva
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    12 / 6532 (0.18%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    4 / 6532 (0.06%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 6532 (0.00%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Plasma cell myeloma
         subjects affected / exposed
    2 / 6532 (0.03%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    34 / 6532 (0.52%)
    33 / 6535 (0.50%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 34
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Prostate cancer metastatic
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer recurrent
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Queyrat erythroplasia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer
         subjects affected / exposed
    2 / 6532 (0.03%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cell carcinoma
         subjects affected / exposed
    6 / 6532 (0.09%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland adenoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Secretory adenoma of pituitary
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinonasal papilloma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Small intestine carcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spindle cell sarcoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    3 / 6532 (0.05%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    6 / 6532 (0.09%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    4 / 6532 (0.06%)
    8 / 6535 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superficial spreading melanoma stage unspecified
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    4 / 6532 (0.06%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract neoplasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    4 / 6532 (0.06%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal adenocarcinoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage I, with cancer in situ
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage I
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung carcinoma cell type unspecified stage II
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Malignant melanoma stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's lymphoma stage I
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IIIA
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cell carcinoma stage IV
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal cancer stage I
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    16 / 6532 (0.24%)
    11 / 6535 (0.17%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    5 / 6532 (0.08%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Aortic embolus
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    8 / 6532 (0.12%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    3 / 6532 (0.05%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Deep vein thrombosis
         subjects affected / exposed
    14 / 6532 (0.21%)
    15 / 6535 (0.23%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism venous
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    2 / 6532 (0.03%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery perforation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    5 / 6532 (0.08%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    30 / 6532 (0.46%)
    31 / 6535 (0.47%)
         occurrences causally related to treatment / all
    2 / 33
    1 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertensive crisis
         subjects affected / exposed
    15 / 6532 (0.23%)
    9 / 6535 (0.14%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 6532 (0.02%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    6 / 6532 (0.09%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    11 / 6532 (0.17%)
    10 / 6535 (0.15%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 6532 (0.02%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Iliac artery occlusion
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inferior vena cava perforation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    4 / 6532 (0.06%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurogenic shock
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    4 / 6532 (0.06%)
    10 / 6535 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    30 / 6532 (0.46%)
    45 / 6535 (0.69%)
         occurrences causally related to treatment / all
    2 / 39
    0 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral artery aneurysm
         subjects affected / exposed
    3 / 6532 (0.05%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm rupture
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    7 / 6532 (0.11%)
    8 / 6535 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    7 / 6532 (0.11%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    4 / 6532 (0.06%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral coldness
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    16 / 6532 (0.24%)
    11 / 6535 (0.17%)
         occurrences causally related to treatment / all
    2 / 21
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    13 / 6532 (0.20%)
    12 / 6535 (0.18%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian steal syndrome
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adverse event
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    3 / 6532 (0.05%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    2 / 6532 (0.03%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    10 / 6532 (0.15%)
    23 / 6535 (0.35%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    57 / 6532 (0.87%)
    38 / 6535 (0.58%)
         occurrences causally related to treatment / all
    4 / 57
    4 / 38
         deaths causally related to treatment / all
    4 / 57
    4 / 38
    Decreased activity
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related thrombosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drug intolerance
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise tolerance decreased
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site haematoma
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site inflammation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection site phlebitis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site haematoma
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal inflammation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    5 / 6532 (0.08%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    No adverse event
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodule
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    51 / 6532 (0.78%)
    51 / 6535 (0.78%)
         occurrences causally related to treatment / all
    2 / 69
    0 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organ failure
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic mass
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perforation
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 6532 (0.05%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retention cyst
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    5 / 6532 (0.08%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    Sudden death
         subjects affected / exposed
    4 / 6532 (0.06%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    1 / 4
    0 / 3
    Surgical failure
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unevaluable event
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart transplant rejection
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney transplant rejection
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Aborted pregnancy
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adnexal torsion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    11 / 6532 (0.17%)
    18 / 6535 (0.28%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast discharge
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast hyperplasia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast pain
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    4 / 6532 (0.06%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial thickening
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometriosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymal cyst
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital leukoplakia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic ovarian cyst
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic congestion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fluid collection
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic prolapse
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal cyst
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's disease
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    4 / 6532 (0.06%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seminal vesiculitis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spermatocele
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular cyst
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular mass
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal fistula
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    4 / 6532 (0.06%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    23 / 6532 (0.35%)
    15 / 6535 (0.23%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 16
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Asphyxia
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    8 / 6532 (0.12%)
    11 / 6535 (0.17%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    31 / 6532 (0.47%)
    38 / 6535 (0.58%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chylothorax
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphonia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    11 / 6532 (0.17%)
    15 / 6535 (0.23%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Dyspnoea exertional
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottic cyst
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    13 / 6532 (0.20%)
    7 / 6535 (0.11%)
         occurrences causally related to treatment / all
    1 / 13
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 6532 (0.05%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity pneumonitis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal congestion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organising pneumonia
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal stenosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    4 / 6532 (0.06%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    6 / 6532 (0.09%)
    7 / 6535 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Pneumonitis
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    2 / 6532 (0.03%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    23 / 6532 (0.35%)
    20 / 6535 (0.31%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 20
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pulmonary haemorrhage
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pulmonary infarction
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    7 / 6532 (0.11%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    6 / 6532 (0.09%)
    12 / 6535 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Sleep apnoea syndrome
         subjects affected / exposed
    7 / 6532 (0.11%)
    7 / 6535 (0.11%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline personality disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Confusional state
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 6532 (0.02%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed mood
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    10 / 6532 (0.15%)
    9 / 6535 (0.14%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    6 / 6532 (0.09%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    4 / 6532 (0.06%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organic brain syndrome
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic stress disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device lead damage
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device power source issue
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stenosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    4 / 6532 (0.06%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract disorder
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    6 / 6532 (0.09%)
    5 / 6535 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    2 / 6532 (0.03%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    13 / 6532 (0.20%)
    17 / 6535 (0.26%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholecystitis acute
         subjects affected / exposed
    20 / 6532 (0.31%)
    12 / 6535 (0.18%)
         occurrences causally related to treatment / all
    2 / 20
    3 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    4 / 6532 (0.06%)
    4 / 6535 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    27 / 6532 (0.41%)
    15 / 6535 (0.23%)
         occurrences causally related to treatment / all
    0 / 28
    1 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic hepatitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    3 / 6532 (0.05%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hepatic failure
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic steatosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver disorder
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-alcoholic steatohepatitis
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nonalcoholic fatty liver disease
         subjects affected / exposed
    2 / 6532 (0.03%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post cholecystectomy syndrome
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Activated partial thromboplastin time prolonged
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood calcium decreased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose abnormal
         subjects affected / exposed
    3 / 6532 (0.05%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose decreased
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood lactic acid increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    3 / 6535 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram change
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate irregular
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular pressure increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus rhythm
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant evaluation
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trial of void
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    2 / 6532 (0.03%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin I increased
         subjects affected / exposed
    0 / 6532 (0.00%)
    2 / 6535 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal injury
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    3 / 6532 (0.05%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Airway complication of anaesthesia
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    5 / 6532 (0.08%)
    9 / 6535 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass occlusion
         subjects affected / exposed
    1 / 6532 (0.02%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass stenosis
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    0 / 6532 (0.00%)
    1 / 6535 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    1 / 6532 (0.02%)
    0 / 6535 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0