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    Clinical Trial Results:
    Study to evaluate GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged >= 50 years

    Summary
    EudraCT number
    2008-000367-42
    Trial protocol
    ES   FI   FR   DE   GB   SE   EE   IT   CZ  
    Global end of trial date
    27 Jul 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Aug 2016
    First version publication date
    10 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    110390
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01165177
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    09 May 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate VE in the prevention of HZ compared to placebo in adults  50 YOA, as measured by the reduction in herpes zoster (HZ) risk.
    Protection of trial subjects
    The vaccine/product recipients were to be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccine/product. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    02 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 418
    Country: Number of subjects enrolled
    Brazil: 634
    Country: Number of subjects enrolled
    Canada: 631
    Country: Number of subjects enrolled
    Czech Republic: 905
    Country: Number of subjects enrolled
    Estonia: 1110
    Country: Number of subjects enrolled
    Finland: 1422
    Country: Number of subjects enrolled
    France: 624
    Country: Number of subjects enrolled
    Germany: 789
    Country: Number of subjects enrolled
    Hong Kong: 470
    Country: Number of subjects enrolled
    Italy: 358
    Country: Number of subjects enrolled
    Japan: 577
    Country: Number of subjects enrolled
    Korea, Republic of: 539
    Country: Number of subjects enrolled
    Mexico: 914
    Country: Number of subjects enrolled
    Spain: 1057
    Country: Number of subjects enrolled
    Sweden: 1013
    Country: Number of subjects enrolled
    Taiwan: 1281
    Country: Number of subjects enrolled
    United Kingdom: 619
    Country: Number of subjects enrolled
    United States: 2068
    Worldwide total number of subjects
    15429
    EEA total number of subjects
    7897
    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)
    9618
    From 65 to 84 years
    5628
    85 years and over
    183

    Subject disposition

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    Recruitment
    Recruitment details
    Apportionment of approximately 20-25% of the >=70 YOA cohort to persons >=80 YOA ensures that this particularly vulnerable population is adequately represented.

    Pre-assignment
    Screening details
    -

    Pre-assignment period milestones
    Number of subjects started
    15429
    Number of subjects completed
    15405

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    Study vaccine not received: 24
    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, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GSK1437173A Group
    Arm description
    Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK1437173A
    Investigational medicinal product code
    Other name
    gE-AS01B
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The study product was administered according to a 0, 2-month schedule.

    Arm title
    Placebo Group
    Arm description
    Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Saline solution
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The study product was administered according to a 0, 2-month schedule.

    Number of subjects in period 1 [1]
    GSK1437173A Group Placebo Group
    Started
    7695
    7710
    Completed
    6773
    6808
    Not completed
    922
    902
         Subject missed visit
    5
    2
         Protocol deviation
    19
    22
         Subject non-compliant with procedures
    12
    2
         Migrated/moved from study area
    48
    43
         Adverse event, serious fatal
    -
    1
         Consent withdrawn by subject
    372
    356
         Physician decision
    -
    1
         Previous health issues worsening
    9
    11
         Personal Reasons
    1
    4
         Serious Adverse Event
    229
    240
         Lost to follow-up
    188
    195
         Site closure
    7
    5
         Non-serious Adverse Event
    32
    20
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 15429 subjects enrolled in the trial, 24 were assigned codes but did not receive vaccination, hence they were excluded from the study start.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Reporting group values
    GSK1437173A Group Placebo Group Total
    Number of subjects
    7695 7710
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    62.4 ± 9 62.3 ± 9 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    4709 4711 9420
        Male
    2986 2999 5985

    End points

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    End points reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    GSK1437173A 50-59 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

    Subject analysis set title
    GSK1437173A 60-69 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

    Subject analysis set title
    GSK1437173A Over 70 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

    Subject analysis set title
    GSK1437173A Overall Ages Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.

    Subject analysis set title
    Placebo 50-59 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.

    Subject analysis set title
    Placebo 60-69 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.

    Subject analysis set title
    Placebo Over 70 YOA Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.

    Subject analysis set title
    Placebo Overall Ages Group
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.

    Primary: Number of subjects with confirmed Herpes zoster (HZ) cases

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    End point title
    Number of subjects with confirmed Herpes zoster (HZ) cases
    End point description
    Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)
    End point type
    Primary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3492
    2141
    1711
    7344
    3525
    2166
    1724
    7415
    Units: Subjects
    3
    2
    1
    6
    87
    75
    48
    210
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Placebo 50-59 YOA Group v GSK1437173A 50-59 YOA Group
    Number of subjects included in analysis
    7017
    Analysis specification
    Pre-specified
    Analysis type
    [1]
    P-value
    < 0.0001
    Method
    Poisson
    Parameter type
    Risk ratio (RR)
    Point estimate
    96.6
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    89.6
         upper limit
    99.3
    Notes
    [1] - The vaccine efficacy (VE) of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) vaccine, in the 50-59 YOA age strata, was demonstrated as the lower limit (LL) of the two-sided 95% confidence interval (CI) of VE was above 10%.
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo 60-69 YOA Group v GSK1437173A 60-69 YOA Group
    Number of subjects included in analysis
    4307
    Analysis specification
    Pre-specified
    Analysis type
    [2]
    P-value
    < 0.0001
    Method
    Poisson
    Parameter type
    1-Risk Ratio
    Point estimate
    97.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    90.1
         upper limit
    99.7
    Notes
    [2] - The vaccine efficacy (VE) of herpes zoster subunit (HZ/su) vaccine against herpes zoster (HZ) vaccine, in the 60-69 YOA age strata, was demonstrated as the lower limit (LL) of the two-sided 95% confidence interval (CI) of VE was above 10%.
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    GSK1437173A Over 70 YOA Group v Placebo Over 70 YOA Group
    Number of subjects included in analysis
    3435
    Analysis specification
    Pre-specified
    Analysis type
    [3]
    P-value
    = 0.0001
    Method
    Poisson
    Parameter type
    1-Risk Ratio
    Point estimate
    97.9
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    87.9
         upper limit
    100
    Notes
    [3] - HZ VE was demonstrated in subjects ≥ 70 YOA as the LL of the 95% CI for HZ VE was far above 10% for that age stratum.
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo Overall Ages Group v GSK1437173A Overall Ages Group
    Number of subjects included in analysis
    14759
    Analysis specification
    Pre-specified
    Analysis type
    [4]
    P-value
    < 0.0001
    Method
    Poisson
    Parameter type
    1-Risk Ratio
    Point estimate
    97.2
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    93.7
         upper limit
    99
    Notes
    [4] - The VE of HZ/su against HZ, overall was demonstrated as the two sided 95% CI of VE was above 25%.

    Secondary: Number of subjects with any episodes of Post-Herpetic Neuralgia (PHN)

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    End point title
    Number of subjects with any episodes of Post-Herpetic Neuralgia (PHN)
    End point description
    The incidence of PHN was calculated using the modified total vaccinated chort.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3491
    2140
    1709
    7430
    3523
    2166
    1724
    7413
    Units: Subjects
    0
    0
    0
    0
    8
    2
    8
    18
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    GSK1437173A 50-59 YOA Group v Placebo 50-59 YOA Group
    Number of subjects included in analysis
    7014
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0081
    Method
    Poisson Method
    Parameter type
    1-RR
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    40.9
         upper limit
    100
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Placebo 60-69 YOA Group v GSK1437173A 60-69 YOA Group
    Number of subjects included in analysis
    4306
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.5097
    Method
    Poisson Method
    Parameter type
    1-RR
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -442.8
         upper limit
    100
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    GSK1437173A Over 70 YOA Group v Placebo Over 70 YOA Group
    Number of subjects included in analysis
    3433
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    = 0.0078
    Method
    Poisson Method
    Parameter type
    1-RR
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    41.4
         upper limit
    100
    Statistical analysis title
    Statistical analysis 4
    Comparison groups
    Placebo Overall Ages Group v GSK1437173A Overall Ages Group
    Number of subjects included in analysis
    14843
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.0001
    Method
    Poisson Method
    Parameter type
    1-RR
    Point estimate
    100
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    77.1
         upper limit
    100

    Secondary: Number of subjects with a reduction of duration of severe ‘worst’ HZ-associated pain

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    End point title
    Number of subjects with a reduction of duration of severe ‘worst’ HZ-associated pain
    End point description
    Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
    4
    1
    2
    7
    91
    74
    56
    221
    No statistical analyses for this end point

    Secondary: Number of subjects with confirmed HZ episode related mortality

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    End point title
    Number of subjects with confirmed HZ episode related mortality
    End point description
    The analysis focused on the number of subjects who died due to HZ
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3491
    2140
    1709
    7340
    3523
    2166
    1724
    7413
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with HZ related complications

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    End point title
    Number of subjects with HZ related complications
    End point description
    The analysis focused on the incidence of HZ complications in subjects with confirmed HZ
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
    0
    0
    0
    0
    1
    3
    2
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with confirmed HZ episode related hospitalizations

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    End point title
    Number of subjects with confirmed HZ episode related hospitalizations
    End point description
    The analysis focused on confirmed HZ episode related hospitalizations.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3491
    2140
    1709
    7340
    3523
    2166
    1724
    7413
    Units: Subjects
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with a confirmed HZ episode having a reduction of duration of pain medication associated with HZ

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    End point title
    Number of subjects with a confirmed HZ episode having a reduction of duration of pain medication associated with HZ
    End point description
    The analysis focused on patients who experienced a reduction in duration of pain medication administered for HZ in subjects with confirmed HZ
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
    3
    2
    1
    6
    82
    63
    45
    190
    No statistical analyses for this end point

    Secondary: Number of subjects with a confirmed HZ episode taking pain medication associated with HZ

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    End point title
    Number of subjects with a confirmed HZ episode taking pain medication associated with HZ
    End point description
    The analysis focused on subjects taking pain medication due to HZ
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
    3
    2
    1
    6
    82
    63
    45
    190
    No statistical analyses for this end point

    Secondary: Number of days with severe ‘worst’ HZ-associated pain

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    End point title
    Number of days with severe ‘worst’ HZ-associated pain
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    1
    2
    7
    91
    74
    56
    221
    Units: Days
        arithmetic mean (standard deviation)
    12 ± 11.8
    78 ± 0
    9 ± 4.2
    20.6 ± 26.8
    28.7 ± 48.4
    21.6 ± 29.3
    44 ± 74.4
    30.2 ± 51.9
    No statistical analyses for this end point

    Secondary: Number of subjects with confirmed HZ episode related mortality and hospitalizations

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    End point title
    Number of subjects with confirmed HZ episode related mortality and hospitalizations
    End point description
    The analysis focused on confirmed HZ episode related hospitalizations and deaths.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3491
    2140
    1709
    7340
    3523
    2166
    1724
    7413
    Units: Subjects
        Mortality
    0
    0
    0
    0
    0
    0
    0
    0
        Hospitalization
    0
    0
    0
    0
    0
    0
    0
    0
        Mortality or hospitalization
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with HZ related complications, by complication type

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    End point title
    Number of subjects with HZ related complications, by complication type
    End point description
    Complication types included HZ vasculitis, Disseminated Disease, Ophtalmic Disease, Neurologic Disease, Visceral Disease and Stroke.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
        At least one complication
    0
    0
    0
    0
    1
    3
    2
    6
        HZ vasculitis
    0
    0
    0
    0
    0
    1
    0
    1
        Disseminated Disease
    0
    0
    0
    0
    1
    1
    2
    4
        Ophtalmic Disease
    0
    0
    0
    0
    0
    1
    0
    1
        Neurologic Disease
    0
    0
    0
    0
    0
    0
    0
    0
        Visceral Disease
    0
    0
    0
    0
    0
    0
    0
    0
        Stroke
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Distribution of pain medication associated with HZ

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    End point title
    Distribution of pain medication associated with HZ
    End point description
    The distribution of pain medication included 1 to 3 or more separate medications
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    4
    3
    2
    9
    103
    90
    61
    254
    Units: Subjects
        At least one pain medication
    3
    2
    1
    6
    82
    63
    45
    190
        1 pain medication only
    1
    1
    0
    2
    30
    23
    14
    67
        2 pain medications only
    1
    1
    0
    2
    26
    19
    9
    54
        3 pain medications or more
    1
    0
    1
    2
    26
    21
    22
    69
    No statistical analyses for this end point

    Secondary: Number of days of pain medication associated with HZ

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    End point title
    Number of days of pain medication associated with HZ
    End point description
    The analysis was performed in subjects with a confirmed HZ episode
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A 50-59 YOA Group GSK1437173A 60-69 YOA Group GSK1437173A Over 70 YOA Group GSK1437173A Overall Ages Group Placebo 50-59 YOA Group Placebo 60-69 YOA Group Placebo Over 70 YOA Group Placebo Overall Ages Group
    Number of subjects analysed
    3
    2
    1
    6
    82
    63
    45
    190
    Units: Days
        arithmetic mean (standard deviation)
    17.3 ± 14.5
    20.5 ± 16.3
    63 ± 0
    26 ± 21.6
    49.2 ± 121.5
    74.3 ± 166.3
    127.7 ± 266.9
    76.1 ± 181.5
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    Number of subjects with any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    4379
    4375
    Units: Subjects
        Any Pain, Dose 1 (N=4359,4361)
    3120
    352
        Grade 3 Pain, Dose 1 (N=4359,4361)
    159
    6
        Any Redness, Dose 1 (N=4359,4361)
    1225
    40
        Grade 3 Redness, Dose 1 (N=4359,4361)
    82
    0
        Any Swelling, Dose 1 (N=4359,4361)
    810
    31
        Grade 3 Swelling, Dose 1 (N=4359,4361)
    28
    0
        Any Pain, Dose 2 (N=4207,4224)
    2807
    258
        Grade 3 Pain, Dose 2 (N=4207,4224)
    185
    10
        Any Redness, Dose 2 (N=4207,4224)
    1151
    24
        Grade 3 Redness, Dose 2 (N=4207,4224)
    56
    0
        Any Swelling, Dose 2 (N=4207,4224)
    762
    17
        Grade 3 Swelling, Dose 2 (N=4207,4224)
    18
    0
        Any Pain, Overall (N=4379,4375)
    3463
    490
        Grade 3 Pain, Overall (N=4379,4375)
    293
    16
        Any Redness, Overall (N=4379,4375)
    1665
    59
        Grade 3 Redness, Overall (N=4379,4375)
    121
    0
        Any Swelling, Overall (N=4379,4375)
    1153
    46
        Grade 3 Swelling, Overall (N=4379,4375)
    42
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, fever [defined as oral, axillary, rectal or tympanic temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 7-day (Days 0-6) post-vaccination period
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    4372
    4376
    Units: Subjects
        Any Fatigue, Dose 1 (N=4346,4362)
    1395
    531
        Grade 3 Fatigue, Dose 1 (N=4346,4362)
    109
    29
        Related fatigue, Dose 1 (N=4346,4362)
    1153
    355
        Any GI symptoms, Dose 1 (N=4346,4362)
    465
    263
        Grade 3 GI symptoms, Dose 1 (N=4346,4362)
    30
    12
        Related GI symptoms, Dose 1 (N=4346,4362)
    317
    141
        Any Headache, Dose 1 (N=4346,4362)
    1112
    511
        Grade 3 Headache, Dose 1 (N=4346,4362)
    67
    20
        Related Headache, Dose 1 (N=4346,4362)
    891
    341
        Any Myalgia, Dose 1 (N=4346,4362)
    1446
    377
        Grade 3 Myalgia, Dose 1 (N=4346,4362)
    104
    21
        Related Myalgia, Dose 1 (N=4346,4362)
    1231
    265
        Any Shivering, Dose 1 (N=4346,4362)
    632
    166
        Grade 3 Shivering, Dose 1 (N=4346,4362)
    69
    3
        Related Shivering, Dose 1 (N=4346,4362)
    539
    104
        Any Temperature, Dose 1 (N=4346,4362)
    500
    65
        Grade 3 Temperature, Dose 1 (N=4346,4362)
    7
    1
        Related Temperature, Dose 1 (N=4346,4362)
    420
    38
        Any Fatigue, Dose 2 (N=4205,4222)
    1456
    379
        Grade 3 Fatigue, Dose 2 (N=4205,4222)
    157
    18
        Related fatigue, Dose 2 (N=4205,4222)
    1270
    279
        Any GI symptoms, Dose 2 (N=4205,4222)
    495
    183
        Grade 3 GI symptoms, Dose 2 (N=4205,4222)
    33
    14
        Related GI symptoms, Dose 2 (N=4205,4222)
    392
    91
        Any Headache, Dose 2 (N=4205,4222)
    1249
    340
        Grade 3 Headache, Dose 2 (N=4205,4222)
    105
    13
        Related Headache, Dose 2 (N=4205,4222)
    1107
    219
        Any Myalgia, Dose 2 (N=4205,4222)
    1474
    274
        Grade 3 Myalgia, Dose 2 (N=4205,4222)
    160
    13
        Related Myalgia, Dose 2 (N=4205,4222)
    1314
    197
        Any Shivering, Dose 2 (N=4205,4222)
    947
    128
        Grade 3 Shivering, Dose 2 (N=4205,4222)
    139
    9
        Related Shivering, Dose 2 (N=4205,4222)
    838
    88
        Any Temperature, Dose 2 (N=4205,4222)
    645
    72
        Grade 3 Temperature, Dose 2 (N=4205,4222)
    8
    5
        Related Temperature, Dose 2 (N=4205,4222)
    571
    40
        Any Fatigue, Overall (N=4372,4376)
    2006
    728
        Grade 3 Fatigue, Overall (N=4372,4376)
    241
    46
        Related fatigue, Overall (N=4372,4376)
    1724
    522
        Any GI symptoms, Overall (N=4372,4376)
    787
    386
        Grade 3 GI symptoms, Overall (N=4372,4376)
    61
    25
        Related GI symptoms, Overall (N=4372,4376)
    591
    206
        Any Headache, Overall (N=4372,4376)
    1714
    700
        Grade 3 Headache, Overall (N=4372,4376)
    157
    30
        Related Headache, Overall (N=4372,4376)
    1470
    469
        Any Myalgia, Overall (N=4372,4376)
    2023
    529
        Grade 3 Myalgia, Overall (N=4372,4376)
    236
    31
        Related Myalgia, Overall (N=4372,4376)
    1791
    390
        Any Shivering, Overall (N=4372,4376)
    1232
    259
        Grade 3 Shivering, Overall (N=4372,4376)
    192
    11
        Related Shivering, Overall (N=4372,4376)
    1082
    177
        Any Temperature, Overall (N=4372,4376)
    940
    132
        Grade 3 Temperature, Overall (N=4372,4376)
    14
    6
        Related Temperature, Overall (N=4372,4376)
    813
    78
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 symptoms (solicited and unsolicited)

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    End point title
    Number of subjects with any and Grade 3 symptoms (solicited and unsolicited)
    End point description
    End point type
    Secondary
    End point timeframe
    Within the 7-day (Days 0-6) post-vaccination period
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    4457
    4464
    Units: Subjects
        Any solicited or unsolicited symptoms
    3766
    1691
        Grade 3 solicited or unsolicited symptoms
    759
    145
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related potential Immune mediated diseases (pIMDs)

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    End point title
    Number of subjects with any and related potential Immune mediated diseases (pIMDs)
    End point description
    Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) in all subjects
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    7695
    7710
    Units: Subjects
        Any pIMDs
    87
    105
        Related pIMDs
    8
    12
    No statistical analyses for this end point

    Secondary: Number of subjects with AEs with any and related medically attended visit (MAEs)

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    End point title
    Number of subjects with AEs with any and related medically attended visit (MAEs)
    End point description
    Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits in all subjects.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 8 post-vaccination
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    7695
    7710
    Units: Subjects
        Any MAEs
    2952
    3072
        Related MAEs
    142
    60
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    Number of subjects with unsolicited adverse events (AEs)
    End point description
    Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Days 0 - 29) after each vaccination
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    7695
    7710
    Units: Subjects
        Any AEs
    3534
    2426
        Grade 3 AEs
    609
    298
        Related AEs
    2199
    439
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    Number of subjects with serious adverse events (SAEs)
    End point description
    Occurrence and relationship to vaccination of all SAEs in all subjects Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0)
    End point values
    GSK1437173A Group Placebo Group
    Number of subjects analysed
    7695
    7710
    Units: Subjects
        Any SAEs (up to Day 30)
    87
    97
        Related SAEs (up to Day 30)
    1
    3
        Any SAEs (up to Month 14)
    594
    590
        Related SAEs (up to Month 14)
    3
    6
        Any SAEs (up to study end)
    727
    731
        Related SAEs (up to study end)
    3
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: within 7 days post-vaccination Unsolicited AEs: within 30 days post vaccination SAEs: during the entire study period (3 to 5 year period following Day 0)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    GSK1437173A Group
    Reporting group description
    Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.

    Reporting group title
    Placebo Group
    Reporting group description
    Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    <
    Serious adverse events
    GSK1437173A Group Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    594 / 7695 (7.72%)
    590 / 7710 (7.65%)
         number of deaths (all causes)
    208
    221
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 7695 (0.00%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dilatation
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic rupture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding varicose vein
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    2 / 7695 (0.03%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Deep vein thrombosis
         subjects affected / exposed
    3 / 7695 (0.04%)
    5 / 7710 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic vascular disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    8 / 7695 (0.10%)
    10 / 7710 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhage
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypertensive crisis
         subjects affected / exposed
    2 / 7695 (0.03%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 7695 (0.00%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Orthostatic hypertension
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         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
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 7695 (0.03%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral artery stenosis
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral venous disease
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Shock haemorrhagic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarteritis nodosa
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker replacement
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (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 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Angioimmunoblastic t-cell lymphoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adult t-cell lymphoma/leukaemia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 7695 (0.05%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of orbit
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign soft tissue neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct adenocarcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder cancer
         subjects affected / exposed
    3 / 7695 (0.04%)
    5 / 7710 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bladder neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bowen’s disease
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Breast cancer female
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    8 / 7695 (0.10%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer in situ
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Bronchial neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carcinoid tumour of the small bowel
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma recurrent
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    3 / 7695 (0.04%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    7 / 7695 (0.09%)
    11 / 7710 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Diffuse large b-cell lymphoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endometrial adenocarcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extranodal marginal zone b-cell lymphoma (malt type)
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fallopian tube cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastrointestinal neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    4 / 7695 (0.05%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         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
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioma
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Glomus tumour
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    4 / 7695 (0.05%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         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
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Hypopharyngeal cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    3 / 7695 (0.04%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    5 / 7695 (0.06%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukaemia
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    4 / 7695 (0.05%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung adenocarcinoma stage i
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Lung neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    11 / 7695 (0.14%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 9
    0 / 3
    Lymphoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Malignant melanoma
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura metastatic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melanocytic naevus
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to liver
         subjects affected / exposed
    3 / 7695 (0.04%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Metastases to lung
         subjects affected / exposed
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metastases to peritoneum
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Metastases to lymph
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nasopharyngeal cancer
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         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 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Ovarian fibroma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 7695 (0.04%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pancreatic carcinoma
         subjects affected / exposed
    6 / 7695 (0.08%)
    8 / 7710 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Phaeochromocytoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    3 / 7695 (0.04%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pleural mesothelioma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    7 / 7695 (0.09%)
    9 / 7710 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal adenoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer metastatic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 9
    0 / 1
    Testicular neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid neoplasm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chest discomfort
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    12 / 7695 (0.16%)
    10 / 7710 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    11 / 7695 (0.14%)
    15 / 7710 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 15
         deaths causally related to treatment / all
    0 / 11
    0 / 15
    Device dislocation
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drowning
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Drug withdrawal syndrome
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gravitational oedema
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    6 / 7695 (0.08%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    Non-cardiac chest pain
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    0 / 7695 (0.00%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Sudden death
         subjects affected / exposed
    5 / 7695 (0.06%)
    7 / 7710 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 5
    0 / 7
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adjustment disorder
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    4 / 7695 (0.05%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Delirium
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium febrile
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    3 / 7695 (0.04%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Generalised anxiety disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Korsakoff’s syndrome
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Somatoform disorder
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (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
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    4 / 7695 (0.05%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 7695 (0.04%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hypertrophy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrocystic breast disease
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine enlargement
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acetabulum fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm perforation
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ankle fracture
         subjects affected / exposed
    7 / 7695 (0.09%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation complication
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemical poisoning
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Electrical burn
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye penetration
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    5 / 7695 (0.06%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    7 / 7695 (0.09%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flail chest
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    3 / 7695 (0.04%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hip fracture
         subjects affected / exposed
    2 / 7695 (0.03%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated incisional hernia
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 7695 (0.01%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root injury cervical
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    7 / 7695 (0.09%)
    7 / 7710 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rib fracture
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 7695 (0.01%)
    5 / 7710 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Seroma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Snake bite
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal compression fracture
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Spinal cord injury cervical
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tibia fracture
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ulna fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    4 / 7695 (0.05%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic shock
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound dehiscence
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm ruptured
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood heavy metal increased
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    4 / 7695 (0.05%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    8 / 7695 (0.10%)
    19 / 7710 (0.25%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 19
         deaths causally related to treatment / all
    0 / 3
    0 / 10
    Angina pectoris
         subjects affected / exposed
    3 / 7695 (0.04%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    2 / 7695 (0.03%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    6 / 7695 (0.08%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    19 / 7695 (0.25%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Atrial flutter
         subjects affected / exposed
    4 / 7695 (0.05%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial tachycardia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrioventricular block complete
         subjects affected / exposed
    1 / 7695 (0.01%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 7695 (0.03%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    8 / 7695 (0.10%)
    8 / 7710 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 7
    0 / 6
    Cardiac failure
         subjects affected / exposed
    20 / 7695 (0.26%)
    24 / 7710 (0.31%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 27
         deaths causally related to treatment / all
    0 / 11
    0 / 15
    Cardiac failure acute
         subjects affected / exposed
    0 / 7695 (0.00%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac failure chronic
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    14 / 7695 (0.18%)
    10 / 7710 (0.13%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Cardiac valve disease
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiogenic shock
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy alcoholic
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular deconditioning
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    11 / 7695 (0.14%)
    17 / 7710 (0.22%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 19
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    4 / 7695 (0.05%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Mitral valve prolapse
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    28 / 7695 (0.36%)
    27 / 7710 (0.35%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 27
         deaths causally related to treatment / all
    0 / 15
    0 / 13
    Myocardial ischaemia
         subjects affected / exposed
    7 / 7695 (0.09%)
    11 / 7710 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Palpitations
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 7695 (0.04%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ventricular tachycardia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Odontogenic cyst
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Cystic fibrosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hernia congenital
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    2 / 7695 (0.03%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Bronchiectasis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    8 / 7695 (0.10%)
    8 / 7710 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Asthma
         subjects affected / exposed
    6 / 7695 (0.08%)
    5 / 7710 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nasal polyps
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal turbinate hypertrophy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian syndrome
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural calcification
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    3 / 7695 (0.04%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pleurisy
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (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
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         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
    1 / 7695 (0.01%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pulmonary bulla
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    6 / 7695 (0.08%)
    13 / 7710 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (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
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Respiratory arrest
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory acidosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    7 / 7695 (0.09%)
    12 / 7710 (0.16%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 5
    0 / 8
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 7695 (0.08%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anaemia vitamin b12 deficiency
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    2 / 7695 (0.03%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    3 / 7695 (0.04%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Aphasia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery thrombosis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 7695 (0.03%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Cerebral infarction
         subjects affected / exposed
    8 / 7695 (0.10%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Cerebral ischaemia
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebrovascular accident
         subjects affected / exposed
    19 / 7695 (0.25%)
    12 / 7710 (0.16%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 12
         deaths causally related to treatment / all
    0 / 8
    0 / 6
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia alzheimer’s type
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Demyelinating polyneuropathy
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 7695 (0.04%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 7695 (0.01%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-barre syndrome
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    4 / 7695 (0.05%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 7695 (0.01%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ivth nerve paralysis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Migraine
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mononeuritis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis cranial
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 7695 (0.01%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post polio syndrome
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraneoplastic neurological syndrome
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    0 / 7695 (0.00%)
    2 / 7710 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    2 / 7695 (0.03%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Reversible ischaemic neurological deficit
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 7695 (0.03%)
    4 / 7710 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Syncope
         subjects affected / exposed
    8 / 7695 (0.10%)
    8 / 7710 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 7695 (0.04%)
    3 / 7710 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    8 / 7695 (0.10%)
    6 / 7710 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viith nerve paralysis
         subjects affected / exposed
    0 / 7695 (0.00%)
    1 / 7710 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis cerebral
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid ptosis
         subjects affected / exposed
    1 / 7695 (0.01%)
    0 / 7710 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 7695 (0.03%)
    5 / 7710 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma