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    Clinical Trial Results:
    A randomised, double-blind, parallel group, multicentre phase IIIb study to compare ticagrelor with clopidogrel treatment on the risk of cardiovascular death, myocardial infarction and ischaemic stroke in patients with established Peripheral Artery Disease (EUCLID – Examining Use of tiCagreLor In paD)

    Summary
    EudraCT number
    		 2011-004616-36
    Trial protocol
    		 SK   NL   PL   GB   SE   ES   DE   HU   BG   CZ   IT   FR  
    Global end of trial date
    27 Sep 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2017
    First version publication date
    29 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5135C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca R&D
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, 431 83
    Public contact
    Brilinta Global Clinical Lead, AstraZeneca R&D, +46 31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Brilinta Global Clinical Lead, AstraZeneca R&D, +46 31 776 10 00, ClinicalTrialTransparency@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    31 Oct 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Sep 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Sep 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the effect of long-term treatment with ticagrelor versus clopidogrel on the event rate of the composite of CV death, MI, and ischaemic stroke (defined as any stroke not demonstrated to be primarily haemorrhagic) in patients with established PAD. The primary efficacy variable was time from randomisation to first occurrence of any event in the composite of CV death, MI, and ischaemic stroke.
    Protection of trial subjects
    The PI at each centre ensured that the patient was given full and adequate oral and written information about the nature, purpose, possible benefit and risk of the study. The Investigator also notified patients that they were free to withdraw from the study at any time. The Investigator gave the patient the opportunity to ask questions and time to consider the information provided. The Investigator obtained the patient’s signed and dated ICF before conducting any procedure specifically for the study. The Investigator stored the original, signed ICF, and gave a copy to the patient. The Investigator also ensured that any incentives for patients who participated in the study, as well as any provisions for patients harmed as a consequence of study participation, were described in the ICF that was approved by an IRB/IEC. The ICF incorporated (or, in some cases, was accompanied by a separate document incorporating) wording that complied with relevant data protection and privacy legislation. Samples of written patient information and consent forms are provided in Appendix 12.1.3.2.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 567
    Country: Number of subjects enrolled
    Brazil: 643
    Country: Number of subjects enrolled
    Bulgaria: 678
    Country: Number of subjects enrolled
    Canada: 430
    Country: Number of subjects enrolled
    Chile: 161
    Country: Number of subjects enrolled
    China: 423
    Country: Number of subjects enrolled
    Czech Republic: 723
    Country: Number of subjects enrolled
    France: 371
    Country: Number of subjects enrolled
    Germany: 623
    Country: Number of subjects enrolled
    Hungary: 580
    Country: Number of subjects enrolled
    Italy: 285
    Country: Number of subjects enrolled
    Japan: 420
    Country: Number of subjects enrolled
    Mexico: 369
    Country: Number of subjects enrolled
    Netherlands: 234
    Country: Number of subjects enrolled
    Philippines: 128
    Country: Number of subjects enrolled
    Poland: 609
    Country: Number of subjects enrolled
    Romania: 508
    Country: Number of subjects enrolled
    Russian Federation: 935
    Country: Number of subjects enrolled
    Slovakia: 419
    Country: Number of subjects enrolled
    Korea, Republic of: 214
    Country: Number of subjects enrolled
    Spain: 323
    Country: Number of subjects enrolled
    Sweden: 240
    Country: Number of subjects enrolled
    Thailand: 122
    Country: Number of subjects enrolled
    Turkey: 137
    Country: Number of subjects enrolled
    United States: 2615
    Country: Number of subjects enrolled
    Ukraine: 536
    Country: Number of subjects enrolled
    United Kingdom: 297
    Country: Number of subjects enrolled
    Vietnam: 295
    Worldwide total number of subjects
    13885
    EEA total number of subjects
    5890
    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)
    5885
    From 65 to 84 years
    7754
    85 years and over
    246

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted at 821 centres randomising patients across 28 countries. The first patient was enrolled on 04 December 2012. The last visit of the last patient took place on 26 September 2016. In total, 16237 patients were enrolled.

    Pre-assignment
    Screening details
    		 Enrolled patients randomised to study drug: 85.5%; n=13885 Patients who were not randomised: 14.5%; n=2352 Patients with inclusion criteria for symptomatic lower extremity PAD failed: n=489 Patients with poor metabolizer status for CYP2C19: n=616 Patients with other reason: n=1374

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ticagrelor 90 mg bd
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ticagrelor
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    90 mg twice daily

    Arm title
    		 Clopidogrel 75 mg od
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Clopidogrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    75 mg once daily

    Number of subjects in period 1
    		Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Started
    6930
    6955
    Completed
    6807
    6842
    Not completed
    123
    113
         Consent withdrawn by subject
    123
    113

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ticagrelor 90 mg bd
    Reporting group description
    		 -

    Reporting group title
    Clopidogrel 75 mg od
    Reporting group description
    		 -

    Reporting group values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od Total
    Number of subjects
    		 6930 6955 13885
    Age Categorical
    Units: Subjects
        <65 years
    		 2900 2985 5885
        Between 65 and 75 years
    		 2925 2850 5775
        >75 years
    		 1105 1120 2225
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.6 ( 8.4 ) 66.5 ( 8.5 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 1908 1980 3888
        Male
    		 5022 4975 9997
    Ethnicity, Customized
    Units: Subjects
        Hispanic Or Latino
    		 1046 1067 2113
        Not Hispanic Or Latino
    		 5884 5888 11772
    Race, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 63 62 125
        Asian
    		 824 810 1634
        Black Or African American
    		 280 289 569
        Native Hawaiian Or Other Pacific Islander
    		 2 3 5
        Other
    		 110 132 242
        White
    		 5651 5659 11310

    End points

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    End points reporting groups
    Reporting group title
    Ticagrelor 90 mg bd
    Reporting group description
    		 -

    Reporting group title
    Clopidogrel 75 mg od
    Reporting group description
    		 -

    Primary: Composite of CV death/MI/ischemic stroke

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    End point title
    		 Composite of CV death/MI/ischemic stroke
    End point description
    Participants with CV death, MI or ischemic stroke. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, non-CV death date)
    End point type
    Primary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participants
    751
    740
    Statistical analysis title
    		 Composite of CV death/MI/ischemic stroke
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.65 [1]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.13
    Notes
    [1] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: Composite of CV death, MI, ischemic stroke, and ALI

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    End point title
    		 Composite of CV death, MI, ischemic stroke, and ALI
    End point description
    Participants with CV death, MI, ischemic stroke or ALI. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, non-CV death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    839
    833
    Statistical analysis title
    		 Composite of CV death/MI/ischemic stroke/ALI
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.738 [2]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.12
    Notes
    [2] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: CV death

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    End point title
    		 CV death
    End point description
    Participants with CV death. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, non-CV death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    363
    343
    Statistical analysis title
    		 CV death
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.23
    Notes
    [3] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: MI

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    End point title
    		 MI
    End point description
    Participants with MI. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    349
    334
    Statistical analysis title
    		 MI
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.482 [4]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.23
    Notes
    [4] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: All-cause mortality

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    End point title
    		 All-cause mortality
    End point description
    Participants with all-cause death. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    628
    635
    Statistical analysis title
    		 All-cause mortality
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.913 [5]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.11
    Notes
    [5] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: Composite of CV death, MI, and all-cause stroke (ischemic or hemorrhagic)

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    End point title
    		 Composite of CV death, MI, and all-cause stroke (ischemic or hemorrhagic)
    End point description
    Participants with CV death, MI or all-cause stroke. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, non-CV death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    766
    759
    Statistical analysis title
    		 Composite of CV death, MI, and all-cause stroke
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.724 [6]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.13
    Notes
    [6] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: ALI

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    End point title
    		 ALI
    End point description
    Participants with ALI. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    117
    115
    Statistical analysis title
    		 ALI
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.846 [7]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.33
    Notes
    [7] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: Lower extremity revascularization

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    End point title
    		 Lower extremity revascularization
    End point description
    Participants with LER. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    846
    892
    Statistical analysis title
    		 Lower extremity revascularization
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.298 [8]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.05
    Notes
    [8] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Secondary: Any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other])

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    End point title
    		 Any revascularisation (coronary, peripheral [limb, mesenteric, renal, carotid and other])
    End point description
    Participants with any revascularization. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Secondary
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    1211
    1250
    Statistical analysis title
    		 Any revascularisation
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.462 [9]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.05
    Notes
    [9] - The hypothesis will be tested at the 4.94% two-sided significance level to account for the planned interim analysis with the overall type I error preserved at 5%. A hierarchical test sequence will be used to address the issue of multiple testing

    Other pre-specified: Net clinical benefit (composite of CV death/MI/ischemic stroke/fatal bleeding/intracranial bleeding)

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    End point title
    		 Net clinical benefit (composite of CV death/MI/ischemic stroke/fatal bleeding/intracranial bleeding)
    End point description
    Participants with CV death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, non-CV death date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    789
    786
    Statistical analysis title
    		 Net clinical benefit 1
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.793
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.12

    Other pre-specified: Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/fatal bleeding/intracranial bleeding)

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    End point title
    		 Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/fatal bleeding/intracranial bleeding)
    End point description
    Participants with all-cause death, MI, ischemic stroke, fatal bleeding or intracranial bleeding. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    983
    992
    Statistical analysis title
    		 Net clinical benefit 2
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.09

    Other pre-specified: Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/fatal bleeding/intracranial bleeding)

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    End point title
    		 Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/fatal bleeding/intracranial bleeding)
    End point description
    Participants with all-cause death, MI, ischemic stroke, ALI, major amputation, fatal bleeding or intracranial bleeding. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    1119
    1140
    Statistical analysis title
    		 Net clinical benefit 3
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.829
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.08

    Other pre-specified: Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/TIMI major bleeding)

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    End point title
    		 Net clinical benefit (composite of all-cause mortality/MI/ischemic stroke/ALI/major amputation/TIMI major bleeding)
    End point description
    Participants with all-cause death, MI, ischemic stroke, ALI, major amputation or TIMI major bleeding. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    1183
    1199
    Statistical analysis title
    		 Net clinical benefit 4
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.949
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.08

    Other pre-specified: Non-CV death

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    End point title
    		 Non-CV death
    End point description
    Participants with non-CV death. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, CV death)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    250
    272
    Statistical analysis title
    		 Non-CV death
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.377
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.1

    Other pre-specified: Change in ABI/TBI

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    End point title
    		 Change in ABI/TBI
    End point description
    Change in ABI/TBI from baseline
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6908
    6940
    Units: Change in ABI/TBI
    arithmetic mean (standard deviation)
        ABI - 6 months N = 6184(Tica , 6319(Clopi)
    0.016 ( 0.136 )
    0.011 ( 0.134 )
        ABI - End of treatment N = 4951(Tica), 5073(Clopi)
    0.022 ( 0.167 )
    0.016 ( 0.167 )
        TBI - 6 months N = 55(Tica), 48(Clopi)
    0.05 ( 0.132 )
    0.036 ( 0.137 )
        TBI - End of treatment N = 36(Tica), 21(Clopi)
    0.059 ( 0.115 )
    -0.065 ( 0.304 )
    No statistical analyses for this end point

    Other pre-specified: Any amputation caused by PAD

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    End point title
    		 Any amputation caused by PAD
    End point description
    Participants with any amputation caused by PAD. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    179
    208
    Statistical analysis title
    		 Any amputation caused by PAD
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.164
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.06

    Other pre-specified: Major amputation caused by PAD

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    End point title
    		 Major amputation caused by PAD
    End point description
    Participants with major amputation caused by PAD. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    100
    116
    Statistical analysis title
    		 Major amputation caused by PAD
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.306
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.14

    Other pre-specified: CV-related hospitalization

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    End point title
    		 CV-related hospitalization
    End point description
    Participants with hospitalization associated with CV death, hospitalization due to MI, ischemic stroke, lower extremity revascularization, major amputation due to PAD, TIA, coronary revascularization or unstable angina. If no event, censoring occures at the minimum of (PACD, last endpoint assessment date, death date)
    End point type
    Other pre-specified
    End point timeframe
    From randomization to PACD
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6930
    6955
    Units: Participant
    1312
    1314
    Statistical analysis title
    		 CV-related hospitalization
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13885
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.887
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.09

    Other pre-specified: TIMI major bleeding events

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    End point title
    		 TIMI major bleeding events
    End point description
    Participants with TIMI major bleeding event. If no event, censoring occures at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)
    End point type
    Other pre-specified
    End point timeframe
    From the date of first dose and up to and including 7 days following the date of last dose of study drug
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6910
    6932
    Units: Participant
    113
    109
    Statistical analysis title
    		 TIMI major bleeding events
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13842
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.489
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.43

    Other pre-specified: TIMI major or minor bleeding events

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    End point title
    		 TIMI major or minor bleeding events
    End point description
    Participants with TIMI major or minor bleeding event. If no event, censoring occures at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)
    End point type
    Other pre-specified
    End point timeframe
    From the date of first dose and up to and including 7 days following the date of last dose of study drug
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6910
    6932
    Units: Participant
    193
    175
    Statistical analysis title
    		 TIMI major or minor bleeding events
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13842
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.138
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.43

    Other pre-specified: PLATO major bleeding events

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    End point title
    		 PLATO major bleeding events
    End point description
    Participants with PLATO major bleeding event. If no event, censoring occures at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)
    End point type
    Other pre-specified
    End point timeframe
    From the date of first dose and up to and including 7 days following the date of last dose of study drug
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6910
    6932
    Units: Participant
    206
    188
    Statistical analysis title
    		 PLATO major bleeding events
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13842
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.139
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.41

    Other pre-specified: Premature permanent discontinuation of study drug due to any bleeding event

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    End point title
    		 Premature permanent discontinuation of study drug due to any bleeding event
    End point description
    Participants with a permanent discontinuation of study drug due to any bleeding event. If no event, censoring occures at the minimum of (last endpoint assessment date, death date, 7 days after last dose of study drug)
    End point type
    Other pre-specified
    End point timeframe
    From the date of first dose and up to and including 7 days following the date of last dose of study drug
    End point values
    		 Ticagrelor 90 mg bd Clopidogrel 75 mg od
    Number of subjects analysed
    6910
    6932
    Units: Participant
    168
    112
    Statistical analysis title
    		 Permanent discontinuations due to bleedings
    Comparison groups
    Ticagrelor 90 mg bd v Clopidogrel 75 mg od
    Number of subjects included in analysis
    13842
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.24
         upper limit
    		 2

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On or after the date of first dose and up to and including 7 days following the date of last dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Clopidogrel 75mg od
    Reporting group description
    		 -

    Reporting group title
    Ticagrelor 90mg bd
    Reporting group description
    		 -

    Serious adverse events
    		 Clopidogrel 75mg od Ticagrelor 90mg bd
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1788 / 6932 (25.79%)
    1716 / 6910 (24.83%)
         number of deaths (all causes)
    290
    271
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma gastric
         subjects affected / exposed
    9 / 6932 (0.13%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 8
         deaths causally related to treatment / all
    1 / 4
    0 / 3
    Adenocarcinoma of colon
         subjects affected / exposed
    7 / 6932 (0.10%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma of salivary gland
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Adenoma benign
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal gland cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma stage IV
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign bone neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign laryngeal neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign salivary gland neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bladder cancer
         subjects affected / exposed
    12 / 6932 (0.17%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cancer recurrent
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage IV
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Bladder neoplasm
         subjects affected / exposed
    4 / 6932 (0.06%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder transitional cell carcinoma stage III
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bone cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bone neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Brain neoplasm benign
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bronchial neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cervix carcinoma stage III
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrosarcoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic myelomonocytic leukaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    7 / 6932 (0.10%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colon cancer metastatic
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer recurrent
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma stage IV
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated large cell lymphoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ear neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer recurrent
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fibrosarcoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenocarcinoma
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    8 / 6932 (0.12%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    1 / 8
    2 / 8
         deaths causally related to treatment / all
    1 / 4
    0 / 2
    Gastric neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gliomatosis cerebri
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangiopericytoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head and neck cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hodgkin's disease
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Huerthle cell carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insulinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal papillary mucinous neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal proliferative breast lesion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular melanoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive breast carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large cell lung cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    10 / 6932 (0.14%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lip and/or oral cavity cancer
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    11 / 6932 (0.16%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 11
         deaths causally related to treatment / all
    0 / 5
    1 / 3
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung adenocarcinoma stage II
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma stage IV
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung cancer metastatic
         subjects affected / exposed
    10 / 6932 (0.14%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 7
    0 / 7
    Lung carcinoma cell type unspecified stage 0
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung carcinoma cell type unspecified stage IV
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Lung neoplasm
         subjects affected / exposed
    8 / 6932 (0.12%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    22 / 6932 (0.32%)
    27 / 6910 (0.39%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 27
         deaths causally related to treatment / all
    0 / 8
    0 / 13
    Lung squamous cell carcinoma stage I
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung squamous cell carcinoma stage II
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant middle ear neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of eyelid
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm progression
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Meningioma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to bone
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic bronchial carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal sinus cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine carcinoma metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer
         subjects affected / exposed
    6 / 6932 (0.09%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Nonkeratinising carcinoma of nasopharynx
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    5 / 6932 (0.07%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Oral neoplasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian adenoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    6 / 6932 (0.09%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 6
    0 / 2
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pancreatic neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraneoplastic syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion malignant
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal cancer
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    19 / 6932 (0.27%)
    15 / 6910 (0.22%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer stage III
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer
         subjects affected / exposed
    3 / 6932 (0.04%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cell carcinoma
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    5 / 6932 (0.07%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spindle cell sarcoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    8 / 6932 (0.12%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Squamous cell carcinoma of pharynx
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue cancer metastatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter recurrent
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    7 / 6932 (0.10%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric cancer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral cancer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal cancer stage 0
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Waldenstrom's macroglobulinaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Kaposi's sarcoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer recurrent
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic aneurysm
         subjects affected / exposed
    12 / 6932 (0.17%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    12 / 6932 (0.17%)
    7 / 6910 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic thrombosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aorto-duodenal fistula
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Behcet's syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachiocephalic artery stenosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    11 / 6932 (0.16%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    8 / 6932 (0.12%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    5 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    30 / 6932 (0.43%)
    20 / 6910 (0.29%)
         occurrences causally related to treatment / all
    1 / 32
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    9 / 6932 (0.13%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Iliac artery perforation
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    May-Thurner syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    5 / 6932 (0.07%)
    7 / 6910 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis superficial
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renovascular hypertension
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subclavian artery occlusion
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery stenosis
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian steal syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboangiitis obliterans
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicophlebitis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein ruptured
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vena cava thrombosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous perforation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest discomfort
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    7 / 6932 (0.10%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication of device removal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Drowning
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Face oedema
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site erosion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    5 / 6932 (0.07%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    Non-cardiac chest pain
         subjects affected / exposed
    37 / 6932 (0.53%)
    37 / 6910 (0.54%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 40
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (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
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.03%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue inflammation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent restenosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod sting
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy to chemicals
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overlap syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    13 / 6932 (0.19%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast enlargement
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast hyperplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast mass
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymal cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular atrophy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal cyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine pain
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal pain
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    Acute pulmonary oedema
         subjects affected / exposed
    6 / 6932 (0.09%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute respiratory failure
         subjects affected / exposed
    6 / 6932 (0.09%)
    17 / 6910 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Alveolitis allergic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    6 / 6932 (0.09%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma-chronic obstructive pulmonary disease overlap syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchostenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    71 / 6932 (1.02%)
    87 / 6910 (1.26%)
         occurrences causally related to treatment / all
    3 / 100
    3 / 113
         deaths causally related to treatment / all
    0 / 3
    1 / 4
    Chronic respiratory failure
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 6932 (0.06%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    1 / 5
    9 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    3 / 6932 (0.04%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    1 / 3
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 6932 (0.04%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    3 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal dysplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal polyps
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal spasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal stenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    7 / 6932 (0.10%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    6 / 6932 (0.09%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Pneumothorax
         subjects affected / exposed
    4 / 6932 (0.06%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    15 / 6932 (0.22%)
    18 / 6910 (0.26%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary granuloma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hilum mass
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    3 / 6932 (0.04%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    12 / 6932 (0.17%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Respiratory tract inflammation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    5 / 6932 (0.07%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord polyp
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Affective disorder
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder due to a general medical condition
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular somatic symptom disorder
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Delirium
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    8 / 6932 (0.12%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug dependence
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder due to a general medical condition
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device leakage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatine phosphokinase MB increased
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood urea increased
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Computerised tomogram thorax abnormal
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin increased
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    4 / 6932 (0.06%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A virus test positive
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count decreased
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic specific antigen increased
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonella test positive
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stool analysis abnormal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Avulsion fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (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
    2 / 6932 (0.03%)
    1 / 6910 (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
    8 / 6932 (0.12%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    11 / 6932 (0.16%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    13 / 6932 (0.19%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in eye
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Head injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Heat exhaustion
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat illness
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    13 / 6932 (0.19%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Humerus fracture
         subjects affected / exposed
    10 / 6932 (0.14%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypobarism
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site erythema
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    6 / 6932 (0.09%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    6 / 6932 (0.09%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral plexus injury
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle rupture
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve injury
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open globe injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic fracture
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post concussion syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    7 / 6932 (0.10%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    1 / 7
    4 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    11 / 6932 (0.16%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    2 / 12
    2 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural hypotension
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural nausea
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pneumothorax
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation fibrosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    7 / 6932 (0.10%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Scapula fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin injury
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin wound
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    3 / 6932 (0.04%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    7 / 6932 (0.10%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    4 / 7
    3 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    5 / 6932 (0.07%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    5 / 6932 (0.07%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous malformation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal dystrophy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    18 / 6932 (0.26%)
    32 / 6910 (0.46%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    6 / 6932 (0.09%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    8 / 6932 (0.12%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm coronary
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    67 / 6932 (0.97%)
    69 / 6910 (1.00%)
         occurrences causally related to treatment / all
    0 / 69
    1 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
         subjects affected / exposed
    6 / 6932 (0.09%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    4 / 6932 (0.06%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    4 / 6932 (0.06%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 6932 (0.03%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    4 / 6932 (0.06%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    8 / 6932 (0.12%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    23 / 6932 (0.33%)
    28 / 6910 (0.41%)
         occurrences causally related to treatment / all
    1 / 29
    1 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    6 / 6932 (0.09%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    88 / 6932 (1.27%)
    68 / 6910 (0.98%)
         occurrences causally related to treatment / all
    2 / 108
    1 / 81
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    4 / 6932 (0.06%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery dissection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve stenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    4 / 6932 (0.06%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 6932 (0.07%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    5 / 6932 (0.07%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    4 / 6932 (0.06%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular hypokinesia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    5 / 6932 (0.07%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered state of consciousness
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    60 / 6932 (0.87%)
    56 / 6910 (0.81%)
         occurrences causally related to treatment / all
    0 / 64
    1 / 58
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Cerebral atrophy
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    2 / 3
    2 / 2
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Cerebral infarction
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 6932 (0.00%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cranial nerve disorder
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed level of consciousness
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    4 / 6932 (0.06%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    6 / 6932 (0.09%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal convulsions
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysaesthesia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    4 / 6932 (0.06%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    6 / 6932 (0.09%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    2 / 6
    1 / 4
         deaths causally related to treatment / all
    1 / 4
    0 / 1
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    6 / 6932 (0.09%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    3 / 6
    2 / 5
         deaths causally related to treatment / all
    2 / 4
    1 / 1
    Headache
         subjects affected / exposed
    6 / 6932 (0.09%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperaesthesia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paralysis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal carotid artery kinking
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral plexopathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple system atrophy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve root compression
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraparesis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke epilepsy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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
    5 / 6932 (0.07%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial nerve compression
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular pain
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (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 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    7 / 6932 (0.10%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep paralysis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    7 / 6932 (0.10%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 1
    2 / 3
    Syncope
         subjects affected / exposed
    18 / 6932 (0.26%)
    26 / 6910 (0.38%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic encephalopathy
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    6 / 6932 (0.09%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wernicke's encephalopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    38 / 6932 (0.55%)
    39 / 6910 (0.56%)
         occurrences causally related to treatment / all
    8 / 40
    14 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of chronic disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune aplastic anaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Febrile neutropenia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic uraemic syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (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
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 6932 (0.06%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Middle ear effusion
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    7 / 6932 (0.10%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    14 / 6932 (0.20%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    0 / 17
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exophthalmos
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuropathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery embolism
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    6 / 6932 (0.09%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinoschisis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 6932 (0.01%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    9 / 6932 (0.13%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain upper
         subjects affected / exposed
    3 / 6932 (0.04%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acid peptic disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal incontinence
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 6932 (0.01%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Constipation
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    3 / 6932 (0.04%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal polyp
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis haemorrhagic
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric discomfort
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive duodenitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    3 / 3
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    2 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    5 / 6932 (0.07%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    4 / 5
    5 / 6
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    10 / 6932 (0.14%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastritis alcoholic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia haemorrhagic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    38 / 6932 (0.55%)
    34 / 6910 (0.49%)
         occurrences causally related to treatment / all
    29 / 41
    22 / 39
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Gastrointestinal inflammation
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 6932 (0.09%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 6932 (0.04%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileus paralytic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    22 / 6932 (0.32%)
    20 / 6910 (0.29%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intestinal ischaemia
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal polyp
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Large intestine polyp
         subjects affected / exposed
    15 / 6932 (0.22%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    3 / 16
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 6932 (0.03%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery stenosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric panniculitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous pancreatitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal fistula
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis haemorrhagic
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis ulcerative
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    8 / 6932 (0.12%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    9 / 6932 (0.13%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontal disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    6 / 6932 (0.09%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    4 / 6932 (0.06%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal stenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated umbilical hernia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue dysplasia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    7 / 6932 (0.10%)
    9 / 6910 (0.13%)
         occurrences causally related to treatment / all
    4 / 7
    7 / 9
         deaths causally related to treatment / all
    1 / 2
    1 / 1
    Volvulus
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiolitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    8 / 6932 (0.12%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholecystitis acute
         subjects affected / exposed
    10 / 6932 (0.14%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    2 / 10
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    13 / 6932 (0.19%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis alcoholic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatty liver alcoholic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder perforation
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Hepatic cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic haematoma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal cyst
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    8 / 6932 (0.12%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkeratosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrobiosis lipoidica diabeticorum
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panniculitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigoid
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash generalised
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subacute cutaneous lupus erythematosus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling face
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic epidermal necrolysis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    32 / 6932 (0.46%)
    48 / 6910 (0.69%)
         occurrences causally related to treatment / all
    0 / 32
    2 / 52
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Acute prerenal failure
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder prolapse
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    13 / 6932 (0.19%)
    20 / 6910 (0.29%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    10 / 6932 (0.14%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    5 / 11
    4 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    6 / 6932 (0.09%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    5 / 6932 (0.07%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal aneurysm
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal arteriosclerosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal atrophy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    19 / 6932 (0.27%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Renal impairment
         subjects affected / exposed
    7 / 6932 (0.10%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    2 / 6932 (0.03%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urge incontinence
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 6932 (0.00%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract obstruction
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urogenital haemorrhage
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 6932 (0.01%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid mass
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroiditis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrofibrosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    7 / 6932 (0.10%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facet joint syndrome
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    4 / 6932 (0.06%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    15 / 6932 (0.22%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw cyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    6 / 6932 (0.09%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic arthropathy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    41 / 6932 (0.59%)
    40 / 6910 (0.58%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteolysis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 6932 (0.01%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatic disorder
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    7 / 6932 (0.10%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue haemorrhage
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    7 / 6932 (0.10%)
    7 / 6910 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal instability
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal ligament ossification
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    5 / 6932 (0.07%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    1 / 6932 (0.01%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial disorder
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic sclerosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral foraminal stenosis
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess of salivary gland
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute hepatitis B
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anal abscess
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    9 / 6932 (0.13%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous graft site infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical mycobacterial pneumonia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    19 / 6932 (0.27%)
    23 / 6910 (0.33%)
         occurrences causally related to treatment / all
    0 / 19
    2 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    26 / 6932 (0.38%)
    27 / 6910 (0.39%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic hepatitis C
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    3 / 6932 (0.04%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    8 / 6932 (0.12%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corynebacterium bacteraemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    6 / 6932 (0.09%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    7 / 6932 (0.10%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis intestinal haemorrhagic
         subjects affected / exposed
    3 / 6932 (0.04%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Echinococciasis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysematous cholecystitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epiglottitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    13 / 6932 (0.19%)
    12 / 6910 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    3 / 6932 (0.04%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes virus infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    3 / 6932 (0.04%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected seroma
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    6 / 6932 (0.09%)
    8 / 6910 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 6932 (0.03%)
    7 / 6910 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium avium complex infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Necrotising fasciitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    9 / 6932 (0.13%)
    7 / 6910 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    6 / 6932 (0.09%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    164 / 6932 (2.37%)
    137 / 6910 (1.98%)
         occurrences causally related to treatment / all
    0 / 175
    0 / 141
         deaths causally related to treatment / all
    0 / 28
    0 / 15
    Pneumonia bacterial
         subjects affected / exposed
    1 / 6932 (0.01%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative abscess
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    10 / 6932 (0.14%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    4 / 6932 (0.06%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    1 / 6932 (0.01%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 6932 (0.07%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    21 / 6932 (0.30%)
    21 / 6910 (0.30%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 21
         deaths causally related to treatment / all
    0 / 7
    0 / 5
    Septic shock
         subjects affected / exposed
    13 / 6932 (0.19%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 7
    0 / 9
    Sialoadenitis
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic abscess
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    3 / 6932 (0.04%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tetanus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tracheostomy infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 6932 (0.00%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculous pleurisy
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 6932 (0.06%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stricture post infection
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    40 / 6932 (0.58%)
    32 / 6910 (0.46%)
         occurrences causally related to treatment / all
    0 / 48
    1 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection fungal
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    4 / 6932 (0.06%)
    13 / 6910 (0.19%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Varicella zoster virus infection
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    3 / 6932 (0.04%)
    4 / 6910 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Dehydration
         subjects affected / exposed
    9 / 6932 (0.13%)
    10 / 6910 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    10 / 6932 (0.14%)
    14 / 6910 (0.20%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    18 / 6932 (0.26%)
    11 / 6910 (0.16%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    3 / 6932 (0.04%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    2 / 6932 (0.03%)
    3 / 6910 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    2 / 6932 (0.03%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gout
         subjects affected / exposed
    5 / 6932 (0.07%)
    2 / 6910 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    9 / 6932 (0.13%)
    15 / 6910 (0.22%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    3 / 6932 (0.04%)
    5 / 6910 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperosmolar hyperglycaemic state
         subjects affected / exposed
    2 / 6932 (0.03%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    12 / 6932 (0.17%)
    17 / 6910 (0.25%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    5 / 6932 (0.07%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    10 / 6932 (0.14%)
    6 / 6910 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic disorder
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolic syndrome
         subjects affected / exposed
    2 / 6932 (0.03%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock hypoglycaemic
         subjects affected / exposed
    1 / 6932 (0.01%)
    0 / 6910 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 6932 (0.00%)
    1 / 6910 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Clopidogrel 75mg od Ticagrelor 90mg bd
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    989 / 6932 (14.27%)
    1682 / 6910 (24.34%)
    Vascular disorders
    Haemorrhage
         subjects affected / exposed
    787 / 6932 (11.35%)
    997 / 6910 (14.43%)
         occurrences all number
    1078
    1451
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    264 / 6932 (3.81%)
    817 / 6910 (11.82%)
         occurrences all number
    289
    968

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2013
    The sample size increased from 11500 to 13500 patients; ALI requiring hospitalization added as exploratory endpoint; time period for ESTV changed from "within 15 days after PACD" to "as soon as possible but not later than 60 days after PACD"; updated contact information for medical emergencies
    03 Mar 2015
    Secondary objectives changed, "Composite of CV death and MI" revised to "Composite of CV death, MI, Ischemic Stroke and Acute Limb Ischemia (ALI) requiring hospitalization", "ALI requiring hospitalization" changed from other objective to secondary objective, "All Lower Extremity Revascularization" added, "All revascularization (coronary and peripheral [limb, mesenteric, renal, carotid and other])" revised to "All revascularization procedures"; Other objectives changed, "Net clinical benefit composed of primary outcome events and fatal or intracranial bleeding" added, "Lower extremity revascularisation" removed, "All amputations due to PAD" added; expected study duration increased, minimum from 18 to 25 months, maximum from 36 to 40 months, median from 27 to 32; reduction in power from 90% to 85%; predetermined number of events decreased from 1596 to 1364; updated contact information for medical emergencies

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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