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    Clinical Trial Results:
    Ensayo clínico de vacunación fase III, aleatorizado, observador-ciego, controlado con placebo, multicéntrico para evaluar la eficacia profiláctica, seguridad e inmunogenicidad de la vacuna gE/AS01B de GSK Biologicals administrada por vía intramuscular con un esquema de 0, 2 meses en adultos de 70 años y mayores.

    Summary
    EudraCT number
    		 2009-015791-94
    Trial protocol
    		 ES   FI   DE   GB   SE   EE   FR   IT   CZ  
    Global end of trial date
    24 Jul 2015

    Results information
    Results version number
    		 v1
    This version publication date
    08 Aug 2016
    First version publication date
    08 Aug 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    113077
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02723773
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Jan 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Zoster-022 study: To evaluate vaccine efficacy (VE) in the prevention of herpes Zoster (HZ) compared to placebo in adults ≥ 70 years of age (YOA), as measured by the reduction in HZ risk. • Zoster-006 and Zoster-022 pooled studies: To evaluate VE in the prevention of postherpetic neuralgia (PHN) compared to placebo in subjects ≥ 70 YOA across both Phase III studies. To consolidate VE estimation in the prevention of HZ compared to placebo in subjects ≥ 70 YOA across both Phase III studies.
    Protection of trial subjects
    The vaccine/product recipients were to be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccine/product. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products. Subjects were followed-up for 30 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Aug 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1879
    Country: Number of subjects enrolled
    Australia: 309
    Country: Number of subjects enrolled
    Brazil: 627
    Country: Number of subjects enrolled
    Canada: 802
    Country: Number of subjects enrolled
    Czech Republic: 321
    Country: Number of subjects enrolled
    Estonia: 1015
    Country: Number of subjects enrolled
    Finland: 1705
    Country: Number of subjects enrolled
    France: 575
    Country: Number of subjects enrolled
    Germany: 1202
    Country: Number of subjects enrolled
    Hong Kong: 180
    Country: Number of subjects enrolled
    Italy: 109
    Country: Number of subjects enrolled
    Japan: 511
    Country: Number of subjects enrolled
    Korea, Republic of: 528
    Country: Number of subjects enrolled
    Mexico: 453
    Country: Number of subjects enrolled
    Spain: 934
    Country: Number of subjects enrolled
    Sweden: 961
    Country: Number of subjects enrolled
    Taiwan: 1110
    Country: Number of subjects enrolled
    United Kingdom: 692
    Worldwide total number of subjects
    13913
    EEA total number of subjects
    7514
    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)
    13913
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Pre-assignment period milestones
    Number of subjects started
    		 13913
    Number of subjects completed
    		 13900

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 No vaccination received: 13
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Zoster-022 GSK1437173A Group
    Arm description
    		 Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.
    Arm type
    		 Experimental

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

    Arm title
    		 Zoster-022 Placebo Group
    Arm description
    		 Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.
    Arm type
    		 Placebo

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

    Number of subjects in period 1 [1]
    		Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Started
    6950
    6950
    Completed
    5770
    5761
    Not completed
    1180
    1189
         Lack of time
    1
    -
         Patient not eligible
    -
    1
         Sponsor study termination
    1
    -
         No reason from the subject
    -
    1
         Health issues
    61
    56
         Suspected HZ Episode
    -
    2
         Site closure
    18
    20
         Serious Adverse Event
    459
    487
         Consent withdrawn by subject
    396
    401
         Page entered in error
    -
    1
         Non-Serious Adverse Event
    47
    15
         Personal reason
    10
    4
         Missed visit
    1
    -
         Investigator decision
    -
    2
         Migrated/moved from study area
    51
    46
         Screening criteria unmet
    1
    -
         Lost to follow-up
    124
    140
         Protocol deviation
    10
    12
         Unknown completion status
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of the 13913 subjects enrolled in the trial, 13 were assigned particiapnt codes but did not receive vaccination, hence were excluded from study start.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Zoster-022 GSK1437173A Group
    Reporting group description
    		 Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Reporting group title
    Zoster-022 Placebo Group
    Reporting group description
    		 Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Reporting group values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group Total
    Number of subjects
    		 6950 6950
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 75.6 ( 4.7 ) 75.6 ( 4.7 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 3789 3836 7625
        Male
    		 3161 3114 6275

    End points

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    End points reporting groups
    Reporting group title
    Zoster-022 GSK1437173A Group
    Reporting group description
    		 Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Reporting group title
    Zoster-022 Placebo Group
    Reporting group description
    		 Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 GSK1437173A 70-79YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 GSK1437173A >=80YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 GSK1437173A >=70YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 Placebo 70-79YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 Placebo >=80YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022 Placebo >=70YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A 70-79YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A >=80YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A >=70YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo 70-79YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo >=80YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo >=70YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 50 and 59 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 60 and 69 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A >=80 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo 50-59 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 50 and 59 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo 60-69 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 60 and 69 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo 70-79 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects between 70 and 79 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo >=80 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 80 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled GSK1437173A >=70 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Subject analysis set title
    Zoster-022/006 Pooled Placebo >=70 YOA Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects above 70 years of age (YOA), receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Primary: Number of subjects with any episodes of herpes zoster (HZ)

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    End point title
    		 Number of subjects with any episodes of herpes zoster (HZ)
    End point description
    Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
    End point type
    Primary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    5114
    1427
    6541
    5189
    1433
    6622
    Units: Subjects
    17
    6
    23
    169
    54
    223
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Zoster-022 Placebo 70-79YOA Group v Zoster-022 GSK1437173A 70-79YOA Group
    Number of subjects included in analysis
    10303
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    90.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 83.54
         upper limit
    		 94.32
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Zoster-022 Placebo >=80YOA Group v Zoster-022 GSK1437173A >=80YOA Group
    Number of subjects included in analysis
    2860
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    89.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 74.65
         upper limit
    		 96.16
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Zoster-022 GSK1437173A >=70YOA Group v Zoster-022 Placebo >=70YOA Group
    Number of subjects included in analysis
    13163
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    89.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 84.29
         upper limit
    		 93.66

    Primary: Outcome measure for the pooled analysis of combined data from studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of subjects with post-herpetic neuralgia (PHN)

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of subjects with post-herpetic neuralgia (PHN)
    End point description
    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).
    End point type
    Primary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 70-79YOA Group Zoster-022/006 Pooled GSK1437173A >=80YOA Group Zoster-022/006 Pooled GSK1437173A >=70YOA Group Zoster-022/006 Pooled Placebo 70-79YOA Group Zoster-022/006 Pooled Placebo >=80YOA Group Zoster-022/006 Pooled Placebo >=70YOA Group
    Number of subjects analysed
    6468
    1782
    8250
    6554
    1792
    8346
    Units: Subjects
    2
    2
    4
    29
    7
    36
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Zoster-022/006 Pooled GSK1437173A 70-79YOA Group v Zoster-022/006 Pooled Placebo 70-79YOA Group
    Number of subjects included in analysis
    13022
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    93.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 72.47
         upper limit
    		 99.19
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Zoster-022/006 Pooled GSK1437173A >=80YOA Group v Zoster-022/006 Pooled Placebo >=80YOA Group
    Number of subjects included in analysis
    3574
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1844
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    71.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -51.51
         upper limit
    		 97.08
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Zoster-022/006 Pooled GSK1437173A >=70YOA Group v Zoster-022/006 Pooled Placebo >=70YOA Group
    Number of subjects included in analysis
    16596
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    88.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 68.7
         upper limit
    		 97.1

    Primary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with confirmed HZ
    End point description
    Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.
    End point type
    Primary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 70-79YOA Group Zoster-022/006 Pooled GSK1437173A >=80YOA Group Zoster-022/006 Pooled GSK1437173A >=70YOA Group Zoster-022/006 Pooled Placebo 70-79YOA Group Zoster-022/006 Pooled Placebo >=80YOA Group Zoster-022/006 Pooled Placebo >=70YOA Group
    Number of subjects analysed
    6468
    1782
    8250
    6554
    1792
    8346
    Units: Subjects
    19
    6
    25
    216
    68
    284
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Zoster-022/006 Pooled GSK1437173A 70-79YOA Group v Zoster-022/006 Pooled Placebo 70-79YOA Group
    Number of subjects included in analysis
    13022
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    91.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 86.04
         upper limit
    		 94.85
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Zoster-022/006 Pooled GSK1437173A >=80YOA Group v Zoster-022/006 Pooled Placebo >=80YOA Group
    Number of subjects included in analysis
    3574
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    91.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 80.22
         upper limit
    		 96.94
    Statistical analysis title
    		 Statistical analysis 3
    Comparison groups
    Zoster-022/006 Pooled Placebo >=70YOA Group v Zoster-022/006 Pooled GSK1437173A >=70YOA Group
    Number of subjects included in analysis
    16596
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 < 0.0001
    Method
    		 Poisson
    Parameter type
    		 1-RR
    Point estimate
    91.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 86.88
         upper limit
    		 94.46

    Secondary: Number of subjects with post-herpetic neuralgia (PHN)

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    End point title
    		 Number of subjects with post-herpetic neuralgia (PHN)
    End point description
    PHN cases in the mTVc.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    5114
    1427
    6541
    5189
    1433
    6622
    Units: Subjects
    2
    2
    4
    22
    6
    28
    No statistical analyses for this end point

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

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    End point title
    		 Number of days with severe ‘worst’ HZ-associated pain
    End point description
    Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    15
    3
    18
    150
    48
    198
    Units: Days
        arithmetic mean (standard deviation)
    21.8 ( 31.41 )
    98.7 ( 57.73 )
    34.6 ( 45.54 )
    47.9 ( 100.08 )
    50.4 ( 106.51 )
    48.5 ( 101.4 )
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with confirmed HZ episode related mortality and hospitalizations
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    5114
    1427
    6541
    5189
    1433
    6622
    Units: Subjects
        Mortality
    0
    0
    0
    0
    0
    0
        Hospitalization
    0
    0
    0
    3
    2
    5
        Mortality or hospitalization
    0
    0
    0
    3
    2
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with overall mortality and HZ-related mortality

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    End point title
    		 Number of subjects with overall mortality and HZ-related mortality
    End point description
    Incidence of overall and HZ-related mortality during the study.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    5114
    1427
    6541
    5189
    1433
    6622
    Units: Subjects
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with confirmed HZ episode related hospitalizations

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    End point title
    		 Number of subjects with confirmed HZ episode related hospitalizations
    End point description
    Incidence of overall and HZ-related hospitalizations during the study.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    5114
    1427
    6541
    5189
    1433
    6622
    Units: Subjects
    0
    0
    0
    3
    2
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with HZ related complications

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    End point title
    		 Number of subjects with HZ related complications
    End point description
    Incidence of HZ complications during the study in subjects with confirmed HZ.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    17
    6
    23
    169
    54
    223
    Units: Subjects
        At least one complication
    1
    0
    1
    6
    4
    10
        HZ vasculitis
    0
    0
    0
    0
    0
    0
        Disseminated Disease
    0
    0
    0
    0
    2
    2
        Ophthalmic Disease
    1
    0
    1
    4
    2
    6
        Neurologic Disease
    0
    0
    0
    3
    0
    3
        Visceral Disease
    0
    0
    0
    0
    0
    0
        Stroke
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects receiving pain medication associated with HZ

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    End point title
    		 Number of subjects receiving pain medication associated with HZ
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    17
    6
    23
    169
    54
    223
    Units: Subjects
        At least 1 pain medication
    7
    3
    10
    123
    37
    160
        1 pain medication only
    5
    0
    5
    43
    17
    60
        2 pain medications only
    0
    1
    1
    30
    4
    34
        3 pain medications or more
    2
    2
    4
    50
    16
    66
    No statistical analyses for this end point

    Secondary: Number of days with pain medication associated with HZ

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    End point title
    		 Number of days with pain medication associated with HZ
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A 70-79YOA Group Zoster-022 GSK1437173A >=80YOA Group Zoster-022 GSK1437173A >=70YOA Group Zoster-022 Placebo 70-79YOA Group Zoster-022 Placebo >=80YOA Group Zoster-022 Placebo >=70YOA Group
    Number of subjects analysed
    7
    3
    10
    123
    37
    160
    Units: Days
        arithmetic mean (standard deviation)
    38.7 ( 56.44 )
    274.7 ( 337 )
    109.5 ( 200.88 )
    218.6 ( 593.8 )
    135 ( 207.31 )
    199.3 ( 530.6 )
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed.
    End point type
    Secondary
    End point timeframe
    Within the 7 days (Days 0-6) after each vaccination
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    505
    505
    Units: Subjects
        Any Pain, Dose 1 (N=502;504)
    297
    26
        Grade 3 Pain, Dose 1 (N=502;504)
    12
    1
        Any Redness, Dose 1 (N=502;504)
    143
    3
        Grade 3 Redness, Dose 1 (N=502;504)
    9
    0
        Any Swelling, Dose 1 (N=502;504)
    85
    2
        Grade 3 Swelling, Dose 1 (N=502;504)
    2
    0
        Any Pain, Dose 2 (N=492;491)
    282
    23
        Grade 3 Pain, Dose 2 (N=492;491)
    12
    0
        Any Redness, Dose 2 (N=492;491)
    137
    3
        Grade 3 Redness, Dose 2 (N=492;491)
    15
    0
        Any Swelling, Dose 2 (N=492;491)
    68
    0
        Grade 3 Swelling, Dose 2 (N=492;491)
    7
    0
        Any Pain, Across Doses (N=505;505)
    347
    43
        Grade 3 Pain, Across Doses (N=505;505)
    22
    1
        Any Redness, Across Doses (N=505;505)
    198
    5
        Grade 3 Redness, Across Doses (N=505;505)
    20
    0
        Any Swelling, Across Doses (N=505;505)
    114
    2
        Grade 3 Swelling, Across Doses (N=505;505)
    8
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 7 days (Days 0-6) post-vaccination period
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    501
    505
    Units: Subjects
        Any Fatigue, Dose 1 (N=501;503)
    104
    56
        Grade 3 Fatigue, Dose 1 (N=501;503)
    8
    4
        Related Fatigue, Dose 1 (N=501;503)
    85
    34
        Any Gastrointestinal, Dose 1 (N=501;503)
    25
    28
        Grade 3 Gastrointestinal, Dose 1 (N=501;503)
    3
    2
        Related Gastrointestinal, Dose 1 (N=501;503)
    16
    14
        Any Headache, Dose 1 (N=501;503)
    72
    42
        Grade 3 Headache, Dose 1 (N=501;503)
    2
    4
        Related Headache, Dose 1 (N=501;503)
    58
    27
        Any Myalgia, Dose 1 (N=501;503)
    106
    27
        Grade 3 Myalgia, Dose 1 (N=501;503)
    6
    2
        Related Myalgia, Dose 1 (N=501;503)
    91
    16
        Any Shivering, Dose 1 (N=501;503)
    38
    17
        Grade 3 Shivering, Dose 1 (N=501;503)
    1
    1
        Related Shivering, Dose 1 (N=501;503)
    32
    12
        Any Temperature, Dose 1 (N=501;503)
    39
    9
        Grade 3 Temperature, Dose 1 (N=501;503)
    0
    2
        Related Temperature, Dose 1 (N=501;503)
    31
    4
        Any Fatigue, Dose 2 (N=492;489)
    122
    39
        Grade 3 Fatigue, Dose 2 (N=492;489)
    9
    0
        Related Fatigue, Dose 2 (N=492;489)
    105
    30
        Any Gastrointestinal, Dose 2 (N=492;489)
    37
    19
        Grade 3 Gastrointestinal, Dose 2 (N=492;489)
    3
    1
        Related Gastrointestinal, Dose 2 (N=492;489)
    26
    13
        Any Headache, Dose 2 (N=492;489)
    76
    26
        Grade 3 Headache, Dose 2 (N=492;489)
    4
    0
        Related Headache, Dose 2 (N=492;489)
    63
    20
        Any Myalgia, Dose 2 (N=492;489)
    113
    18
        Grade 3 Myalgia, Dose 2 (N=492;489)
    7
    0
        Related Myalgia, Dose 2 (N=492;489)
    94
    16
        Any Shivering, Dose 2 (N=492;489)
    59
    11
        Grade 3 Shivering, Dose 2 (N=492;489)
    5
    1
        Related Shivering, Dose 2 (N=492;489)
    47
    9
        Any Temperature, Dose 2 (N=492;489)
    38
    6
        Grade 3 Temperature, Dose 2 (N=492;489)
    0
    2
        Related Temperature, Dose 2 (N=492;489)
    35
    2
        Any Fatigue, Across Doses (N=504;505)
    166
    77
        Grade 3 Fatigue, Across Doses (N=504;505)
    16
    4
        Related Fatigue, Across Doses (N=504;505)
    140
    52
        Any Gastrointestinal, Across Doses (N=504;505)
    55
    40
        Grade 3 Gastrointestinal, Across Doses (N=504;505)
    5
    2
        Related Gastrointestinal, Across Doses (N=504;505)
    38
    21
        Any Headache, Across Doses (N=504;505)
    124
    55
        Grade 3 Headache, Across Doses (N=504;505)
    5
    4
        Related Headache, Across Doses (N=504;505)
    104
    37
        Any Myalgia, Across Doses (N=504;505)
    157
    41
        Grade 3 Myalgia, Across Doses (N=504;505)
    12
    2
        Related Myalgia, Across Doses (N=504;505)
    137
    29
        Any Shivering, Across Doses (N=504;505)
    75
    22
        Grade 3 Shivering, Across Doses (N=504;505)
    6
    2
        Related Shivering, Across Doses (N=504;505)
    64
    16
        Any Temperature, Across Doses (N=504;505)
    62
    13
        Grade 3 Temperature, Across Doses (N=504;505)
    0
    2
        Related Temperature, Across Doses (N=504;505)
    54
    6
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 30 days (Days 0-29) after each vaccination
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    6950
    6950
    Units: Subjects
        Any AE(s)
    3859
    2263
        Grade 3 AE(s)
    485
    265
        Related AE(s)
    2853
    529
    No statistical analyses for this end point

    Secondary: Number of subjects with any, related and fatal serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any, related and fatal serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    6950
    6695
    Units: Subjects
        Any SAE(s) up to Month 14
    891
    939
        Related SAE(s) up to Month 14
    12
    7
        Fatal SAE(s) up to Month 14
    101
    110
        Any SAE(s) up to study end
    1153
    1214
        Related SAE(s) up to study end
    12
    8
        Fatal SAE(s) up to study end
    426
    459
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune mediated diseases (pIMDs)

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    End point title
    		 Number of subjects with potential immune mediated diseases (pIMDs)
    End point description
    Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    6950
    6950
    Units: Subjects
    92
    97
    No statistical analyses for this end point

    Secondary: Number of subjects with Medically Attended events (MAEs)

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    End point title
    		 Number of subjects with Medically Attended events (MAEs)
    End point description
    Occurrence and relationship to vaccination of medically attended visitsother than routine health care visits, from Month 0 to Month 8 in all subjects. MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 8 post-vaccination
    End point values
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group
    Number of subjects analysed
    6950
    6950
    Units: Subjects
        Any MAE(s)
    2882
    2911
        Related MAE(s)
    165
    66
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall number of subjects with PHN in subjects ≥ 50 YOA

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall number of subjects with PHN in subjects ≥ 50 YOA
    End point description
    Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled Placebo 50-59 YOA Group Zoster-022/006 Pooled Placebo 60-69 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group
    Number of subjects analysed
    3491
    2140
    6468
    1782
    3523
    2166
    6554
    1792
    Units: Subjects
    0
    0
    2
    2
    8
    2
    29
    7
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with a reduction of PHN incidence in subjects ≥ 50 YOA with confirmed HZ

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with a reduction of PHN incidence in subjects ≥ 50 YOA with confirmed HZ
    End point description
    Occurrence of PHN during the entire study period in all subjects with confirmed HZ.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 50-59 YOA Group Zoster-022/006 Pooled GSK1437173A 60-69 YOA Group Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled Placebo 50-59 YOA Group Zoster-022/006 Pooled Placebo 60-69 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group
    Number of subjects analysed
    4
    3
    19
    6
    103
    90
    216
    68
    Units: Subjects
    0
    0
    2
    2
    8
    2
    29
    7
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with reduction of duration of severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with reduction of duration of severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.
    End point description
    Number of subjects with reduction of duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    19
    6
    216
    68
    25
    284
    Units: Subjects
    17
    3
    193
    61
    20
    254
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of days with severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of days with severe ‘worst’ HZ-associated pain in subjects ≥ 70 YOA with confirmed HZ.
    End point description
    Reduction of duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A 70-79 YOA Group Zoster-022/006 Pooled GSK1437173A >=80 YOA Group Zoster-022/006 Pooled Placebo 70-79 YOA Group Zoster-022/006 Pooled Placebo >=80 YOA Group Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    19
    6
    216
    68
    25
    284
    Units: Days
        number (not applicable)
    347
    299
    9338
    2764
    646
    12102
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Relationship analysis was not performed..
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0-6) after each vaccination
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    2258
    2263
    Units: Subjects
        Any Pain, Dose 1 (N=2246;2255)
    1336
    128
        Grade 3 Pain, Dose 1 (N=2246;2255)
    42
    1
        Any Redness, Dose 1 (N=2246;2255)
    606
    17
        Grade 3 Redness, Dose 1 (N=2246;2255)
    43
    0
        Any Swelling, Dose 1 (N=2246;2255)
    455
    17
        Grade 3 Swelling, Dose 1 (N=2246;2255)
    17
    0
        Any Pain, Dose 2 (N=2160;2169)
    1241
    107
        Grade 3 Pain, Dose 2 (N=2160;2169)
    60
    3
        Any Redness, Dose 2 (N=2160;2169)
    582
    14
        Grade 3 Redness, Dose 2 (N=2160;2169)
    39
    0
        Any Swelling, Dose 2 (N=2160;2169)
    344
    10
        Grade 3 Swelling, Dose 2 (N=2160;2169)
    15
    0
        Any Pain, Across Doses (N=2258;2263)
    1562
    199
        Grade 3 Pain, Across Doses (N=2258;2263)
    290
    4
        Any Redness, Across Doses (N=2258;2263)
    851
    27
        Grade 3 Redness, Across Doses (N=2258;2263)
    70
    0
        Any Swelling, Across Doses (N=2258;2263)
    519
    25
        Grade 3 Swelling, Across Doses (N=2258;2263)
    30
    0
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, Grade 3 and related solicited general symptoms

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Days 0-6) after each vaccination
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    2252
    2264
    Units: Subjects
        Any Fatigue, Dose 1 (N=2237;2256)
    545
    231
        Grade 3 Fatigue, Dose 1 (N=2237;2256)
    31
    13
        Related Fatigue, Dose 1 (N=2237;2256)
    441
    147
        Any Gastrointestinal, Dose 1 (N=2237;2256)
    170
    123
        Grade 3 Gastrointestinal, Dose 1 (N=2237;2256)
    15
    6
        Related Gastrointestinal, Dose 1 (N=2237;2256)
    101
    67
        Any Headache, Dose 1 (N=2237;2256)
    380
    189
        Grade 3 Headache, Dose 1 (N=2237;2256)
    7
    8
        Related Headache, Dose 1 (N=2237;2256)
    293
    132
        Any Myalgia, Dose 1 (N=2237;2256)
    530
    159
        Grade 3 Myalgia, Dose 1 (N=2237;2256)
    26
    7
        Related Myalgia, Dose 1 (N=2237;2256)
    445
    101
        Any Shivering, Dose 1 (N=2237;2256)
    206
    73
        Grade 3 Shivering, Dose 1 (N=2237;2256)
    15
    3
        Related Shivering, Dose 1 (N=2237;2256)
    173
    50
        Any Temperature, Dose 1 (N=2237;2256)
    142
    34
        Grade 3 Temperature, Dose 1 (N=2237;2256)
    1
    2
        Related Temperature, Dose 1 (N=2237;2256)
    111
    16
        Any Fatigue, Dose 2 (N=2159;2166)
    579
    169
        Grade 3 Fatigue, Dose 2 (N=2159;2166)
    53
    4
        Related Fatigue, Dose 2 (N=2159;2166)
    495
    116
        Any Gastrointestinal, Dose 2 (N=2159;2166)
    188
    75
        Grade 3 Gastrointestinal, Dose 2 (N=2159;2166)
    14
    5
        Related Gastrointestinal, Dose 2 (N=2159;2166)
    142
    35
        Any Headache, Dose 2 (N=2159;2166)
    455
    133
        Grade 3 Headache, Dose 2 (N=2159;2166)
    30
    2
        Related Headache, Dose 2 (N=2159;2166)
    386
    86
        Any Myalgia, Dose 2 (N=2159;2166)
    560
    112
        Grade 3 Myalgia, Dose 2 (N=2159;2166)
    42
    4
        Related Myalgia, Dose 2 (N=2159;2166)
    484
    75
        Any Shivering, Dose 2 (N=2159;2166)
    334
    55
        Grade 3 Shivering, Dose 2 (N=2159;2166)
    36
    4
        Related Shivering, Dose 2 (N=2159;2166)
    292
    34
        Any Temperature, Dose 2 (N=2159;2166)
    224
    30
        Grade 3 Temperature, Dose 2 (N=2159;2166)
    2
    3
        Related Temperature, Dose 2 (N=2159;2166)
    189
    14
        Any Fatigue, Across Doses (N=2252;2264)
    825
    326
        Grade 3 Fatigue, Across Doses (N=2252;2264)
    79
    17
        Related Fatigue, Across Doses (N=2252;2264)
    699
    220
        Any Gastrointestinal, Across Doses (N=2252;2264)
    304
    172
        Grade 3 Gastrointestinal,Across Doses(N=2252;2264)
    26
    10
        Related Gastrointestinal,Across Doses(N=2252;2264)
    210
    91
        Any Headache, Across Doses (N=2252;2264)
    653
    268
        Grade 3 Headache, Across Doses (N=2252;2264)
    34
    10
        Related Headache, Across Doses (N=2252;2264)
    547
    185
        Any Myalgia, Across Doses (N=2252;2264)
    790
    225
        Grade 3 Myalgia, Across Doses (N=2252;2264)
    62
    10
        Related Myalgia, Across Doses (N=2252;2264)
    689
    157
        Any Shivering, Across Doses (N=2252;2264)
    439
    110
        Grade 3 Shivering, Across Doses (N=2252;2264)
    49
    6
        Related Shivering, Across Doses (N=2252;2264)
    380
    75
        Any Temperature, Across Doses (N=2252;2264)
    323
    61
        Grade 3 Temperature, Across Doses (N=2252;2264)
    3
    3
        Related Temperature, Across Doses (N=2252;2264)
    265
    30
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with unsolicited AEs in subjects ≥ 70 YOA

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with unsolicited AEs in subjects ≥ 70 YOA
    End point description
    Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 30 days (Days 0 - 29) after each vaccination
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    8758
    8773
    Units: Subjects
        Any AE(s)
    4366
    2732
        Grade 3 AE(s)
    553
    335
        Related AE(s)
    2961
    578
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, related and fatal SAEs

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any, related and fatal SAEs
    End point description
    Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 14 and until study end (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    8758
    8773
    Units: Subjects
        Any SAEs up to Mont 14
    1117
    1171
        Related SAEs up to Month 14
    12
    7
        Fatal SAEs up to Month 14
    128
    144
        Any SAEs up to study end
    1447
    1521
        Related SAEs up to study end
    12
    8
        Fatal SAEs up to study end
    539
    580
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any pIMDs

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with any pIMDs
    End point description
    Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.
    End point type
    Secondary
    End point timeframe
    During the entire study period (3 to 5 year period following Day 0)
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    8758
    8773
    Units: Subjects
        Any pIMD(s)
    110
    118
        Related pIMD(s)
    8
    8
    No statistical analyses for this end point

    Secondary: Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with Medically Attended events (MAEs)

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    End point title
    		 Outcome measure for the pooled analysis of combined data from studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of subjects with Medically Attended events (MAEs)
    End point description
    Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.
    End point type
    Secondary
    End point timeframe
    From Month 0 to Month 8 post-vaccination
    End point values
    		 Zoster-022/006 Pooled GSK1437173A >=70 YOA Group Zoster-022/006 Pooled Placebo >=70 YOA Group
    Number of subjects analysed
    8758
    8773
    Units: Subjects
        Any MAE(s)
    3593
    3648
        Related MAE(s)
    180
    80
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: within 7 days after vaccination; Unsolicited adverse events: within 30 days after vaccination; Serious adverse events: during the entire study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Zoster-022 GSK1437173A Group
    Reporting group description
    		 Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Reporting group title
    Zoster-022 Placebo Group
    Reporting group description
    		 Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Reporting group title
    Zoster-022/006 Pooled GSK1437173A Group
    Reporting group description
    		 Subjects receiving herpes zoster subunit vaccine (gE/AS01B vaccine) according to a 0, 2-month schedule.

    Reporting group title
    Zoster-022/006 Pooled Placebo Group
    Reporting group description
    		 Subjects receiving saline solution (NaCl solution) as control according to a 0, 2-month schedule.

    Serious adverse events
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1153 / 6950 (16.59%)
    1214 / 6950 (17.47%)
    1447 / 8758 (16.52%)
    1521 / 8773 (17.34%)
         number of deaths (all causes)
    426
    459
    539
    580
         number of deaths resulting from adverse events
    1
    0
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Acral lentiginous melanoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute monocytic leukaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    Acute promyelocytic leukaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Adenocarcinoma gastric
         subjects affected / exposed
    3 / 6950 (0.04%)
    1 / 6950 (0.01%)
    4 / 8758 (0.05%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 1
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    Adrenal adenoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adrenal gland cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaplastic astrocytoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Anaplastic thyroid cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    B precursor type acute leukaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    5 / 6950 (0.07%)
    3 / 6950 (0.04%)
    7 / 8758 (0.08%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of orbit
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign neoplasm of thyroid gland
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign ovarian tumour
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign renal neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct adenocarcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Bladder cancer
         subjects affected / exposed
    6 / 6950 (0.09%)
    13 / 6950 (0.19%)
    7 / 8758 (0.08%)
    18 / 8773 (0.21%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 7
    0 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    Bladder cancer recurrent
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Bladder papilloma
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Bone cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Bowen’s disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain cancer metastatic
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Brain neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Brain neoplasm benign
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Breast cancer
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Breast cancer metastatic
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Carcinoid tumour of the small bowel
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carcinoid tumour pulmonary
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Central nervous system neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cervix carcinoma recurrent
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 5
    Cholesteatoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Colon adenoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    9 / 6950 (0.13%)
    6 / 6950 (0.09%)
    11 / 8758 (0.13%)
    12 / 8773 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 7
    Colon cancer metastatic
         subjects affected / exposed
    3 / 6950 (0.04%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 3
    Colon neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Diffuse large B-cell lymphoma stage IV
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Endometrial adenocarcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Fallopian tube cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Follicular thyroid cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gallbladder cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Gastric cancer
         subjects affected / exposed
    6 / 6950 (0.09%)
    3 / 6950 (0.04%)
    9 / 8758 (0.10%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 6
    0 / 4
    Gastrointestinal carcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Hepatic cancer
         subjects affected / exposed
    2 / 6950 (0.03%)
    6 / 6950 (0.09%)
    4 / 8758 (0.05%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    0 / 4
    0 / 5
    Hepatic cancer metastatic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Hepatic neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Hepatocellular carcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 2
    Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive lobular breast carcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive papillary breast carcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Large cell lung cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Laryngeal neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Leukaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    6 / 6950 (0.09%)
    3 / 8758 (0.03%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 5
    Lung adenocarcinoma metastatic
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 4
    Lung adenocarcinoma stage III
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    6 / 6950 (0.09%)
    4 / 6950 (0.06%)
    7 / 8758 (0.08%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    0 / 7
    0 / 4
    Lung neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
    Lung neoplasm malignant
         subjects affected / exposed
    22 / 6950 (0.32%)
    13 / 6950 (0.19%)
    27 / 8758 (0.31%)
    16 / 8773 (0.18%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 13
    0 / 27
    0 / 16
         deaths causally related to treatment / all
    0 / 18
    0 / 10
    0 / 23
    0 / 11
    Lymphoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
    Malignant fibrous histiocytoma of bone
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Malignant lymphoma unclassifiable high grade
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant mast cell neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Malignant melanoma in situ
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Malignant palate neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant pleural effusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Mesothelioma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to adrenals
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Metastases to bone
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
    Metastases to central nervous system
         subjects affected / exposed
    4 / 6950 (0.06%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    0 / 1
    Metastases to gastrointestinal tract
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Metastases to liver
         subjects affected / exposed
    5 / 6950 (0.07%)
    5 / 6950 (0.07%)
    7 / 8758 (0.08%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    0 / 5
    0 / 5
    Metastases to lung
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 2
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metastases to peritoneum
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Metastases to stomach
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
    Metastatic malignant melanoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
    Metastatic neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
    Metastatic renal cell carcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Myelodysplastic syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Nasopharyngeal cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
    Neoplasm prostate
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Neuroendocrine carcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Non-Hodgkin’s lymphoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Non-small cell lung cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Non-small cell lung cancer stage IV
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Oesophageal adenocarcinoma metastatic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    6 / 6950 (0.09%)
    1 / 6950 (0.01%)
    6 / 8758 (0.07%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 5
    0 / 1
    0 / 5
    0 / 1
    Oesophageal squamous cell carcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Ovarian cancer
         subjects affected / exposed
    4 / 6950 (0.06%)
    0 / 6950 (0.00%)
    6 / 8758 (0.07%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    0 / 6
    0 / 0
    Ovarian cancer recurrent
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Ovarian epithelial cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian fibroma
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    7 / 6950 (0.10%)
    10 / 6950 (0.14%)
    10 / 8758 (0.11%)
    16 / 8773 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
    0 / 10
    0 / 16
         deaths causally related to treatment / all
    0 / 7
    0 / 10
    0 / 10
    0 / 16
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 2
    Pancreatic neoplasm
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Pancreatic neuroendocrine tumour
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Papillary thyroid cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paraganglion neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parathyroid tumour benign
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Prostate cancer
         subjects affected / exposed
    19 / 6950 (0.27%)
    18 / 6950 (0.26%)
    22 / 8758 (0.25%)
    23 / 8773 (0.26%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 18
    0 / 22
    0 / 23
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    0 / 4
    0 / 5
    Prostate cancer metastatic
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    5 / 8758 (0.06%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    0 / 5
    0 / 1
    Prostate cancer recurrent
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Prostate cancer stage IV
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Prostatic adenoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal adenocarcinoma
         subjects affected / exposed
    4 / 6950 (0.06%)
    1 / 6950 (0.01%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 1
    Rectal adenoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Rectal cancer recurrent
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Renal cancer metastatic
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Renal cell carcinoma
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Renal cell carcinoma recurrent
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Sarcoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Small cell lung cancer metastatic
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Spinal cord neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Squamous cell carcinoma of lung
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Sweat gland tumour
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Testicular neoplasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Throat cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Thyroid cancer
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Urethral neoplasm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vulval cancer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aneurysm ruptured
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    6 / 6950 (0.09%)
    2 / 6950 (0.03%)
    6 / 8758 (0.07%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Aortic aneurysm rupture
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    4 / 8758 (0.05%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
    0 / 3
    Aortic arteriosclerosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dilatation
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Aortic occlusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Aortic rupture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Aortic stenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    8 / 6950 (0.12%)
    0 / 8758 (0.00%)
    10 / 8773 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
    0 / 0
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Arterial disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    5 / 6950 (0.07%)
    2 / 8758 (0.02%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
    Arteriovenous fistula
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bleeding varicose vein
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    5 / 6950 (0.07%)
    3 / 6950 (0.04%)
    6 / 8758 (0.07%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    0 / 5
    0 / 5
    Deep vein thrombosis
         subjects affected / exposed
    6 / 6950 (0.09%)
    9 / 6950 (0.13%)
    6 / 8758 (0.07%)
    11 / 8773 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Embolism
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    1 / 6950 (0.01%)
    6 / 6950 (0.09%)
    1 / 8758 (0.01%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Haemodynamic instability
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Hypertension
         subjects affected / exposed
    22 / 6950 (0.32%)
    25 / 6950 (0.36%)
    25 / 8758 (0.29%)
    32 / 8773 (0.36%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 25
    0 / 25
    0 / 32
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    7 / 6950 (0.10%)
    6 / 6950 (0.09%)
    8 / 8758 (0.09%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    6 / 6950 (0.09%)
    5 / 6950 (0.07%)
    6 / 8758 (0.07%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Inferior vena caval occlusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Internal haemorrhage
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Labile hypertension
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microscopic polyangiitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrosis ischaemic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypertension
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    6 / 6950 (0.09%)
    6 / 6950 (0.09%)
    6 / 8758 (0.07%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Peripheral artery aneurysm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral venous disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Superior vena cava syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Temporal arteritis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thromboangiitis obliterans
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose ulceration
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Hospitalisation
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal polypectomy
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Accidental death
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Administration site erythema
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Administration site pain
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adverse drug reaction
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Chest discomfort
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    20 / 6950 (0.29%)
    19 / 6950 (0.27%)
    24 / 8758 (0.27%)
    22 / 8773 (0.25%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 19
    0 / 24
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chills
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cyst
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    17 / 6950 (0.24%)
    29 / 6950 (0.42%)
    20 / 8758 (0.23%)
    36 / 8773 (0.41%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 29
    0 / 20
    0 / 36
         deaths causally related to treatment / all
    0 / 17
    0 / 29
    0 / 20
    0 / 36
    Device battery issue
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device deposit issue
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Device leakage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Fatigue
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ill-defined disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated hernia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    9 / 6950 (0.13%)
    12 / 6950 (0.17%)
    12 / 8758 (0.14%)
    12 / 8773 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 9
    0 / 11
    0 / 12
    0 / 11
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Organ failure
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Pain
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peripheral swelling
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Strangulated hernia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 6
    Sudden death
         subjects affected / exposed
    13 / 6950 (0.19%)
    4 / 6950 (0.06%)
    16 / 8758 (0.18%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
    0 / 16
    0 / 6
         deaths causally related to treatment / all
    0 / 13
    0 / 4
    0 / 16
    0 / 6
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Thrombosis in device
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergic granulomatous angiitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyloidosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Atrophic vulvovaginitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    9 / 6950 (0.13%)
    7 / 6950 (0.10%)
    10 / 8758 (0.11%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast dysplasia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic obstruction
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal prolapse
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vaginal ulceration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
    Acute respiratory failure
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
    Aspiration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Asthma
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    21 / 6950 (0.30%)
    18 / 6950 (0.26%)
    27 / 8758 (0.31%)
    21 / 8773 (0.24%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 18
    0 / 27
    0 / 21
         deaths causally related to treatment / all
    0 / 8
    0 / 7
    0 / 9
    0 / 9
    Diaphragmatic disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    4 / 8758 (0.05%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Epistaxis
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Idiopathic pulmonary fibrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Lung disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Nasal polyps
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural calcification
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    5 / 6950 (0.07%)
    8 / 6950 (0.12%)
    8 / 8758 (0.09%)
    10 / 8773 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    10 / 6950 (0.14%)
    3 / 6950 (0.04%)
    11 / 8758 (0.13%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    0 / 8
    0 / 5
    Pneumothorax
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary cavitation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    15 / 6950 (0.22%)
    21 / 6950 (0.30%)
    19 / 8758 (0.22%)
    28 / 8773 (0.32%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 21
    0 / 19
    0 / 28
         deaths causally related to treatment / all
    0 / 3
    0 / 9
    0 / 6
    0 / 11
    Pulmonary fibrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
    Pulmonary mass
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 3
    Respiratory arrest
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 1
    Respiratory distress
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    Respiratory failure
         subjects affected / exposed
    15 / 6950 (0.22%)
    15 / 6950 (0.22%)
    20 / 8758 (0.23%)
    23 / 8773 (0.26%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 15
    0 / 20
    0 / 23
         deaths causally related to treatment / all
    0 / 11
    0 / 11
    0 / 16
    0 / 15
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute psychosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breathing-related sleep disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 4
    Confusional state
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Delirium febrile
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depressed mood
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    4 / 6950 (0.06%)
    3 / 6950 (0.04%)
    5 / 8758 (0.06%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental disorder due to a general medical condition
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Panic disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychotic disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizoaffective disorder bipolar type
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Schizophrenia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Somatoform disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Accidental overdose
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aneurysm perforation
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Ankle fracture
         subjects affected / exposed
    3 / 6950 (0.04%)
    5 / 6950 (0.07%)
    4 / 8758 (0.05%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back injury
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bone fissure
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Cervical vertebral fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Chemical poisoning
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    4 / 6950 (0.06%)
    3 / 6950 (0.04%)
    4 / 8758 (0.05%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    4 / 6950 (0.06%)
    5 / 6950 (0.07%)
    4 / 8758 (0.05%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery reocclusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Deep vein thrombosis postoperative
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye penetration
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Fall
         subjects affected / exposed
    8 / 6950 (0.12%)
    5 / 6950 (0.07%)
    9 / 8758 (0.10%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
    Femoral neck fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    6 / 6950 (0.09%)
    4 / 8758 (0.05%)
    10 / 8773 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Femur fracture
         subjects affected / exposed
    10 / 6950 (0.14%)
    15 / 6950 (0.22%)
    15 / 8758 (0.17%)
    17 / 8773 (0.19%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 15
    0 / 15
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Fibula fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fractured sacrum
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Hip fracture
         subjects affected / exposed
    7 / 6950 (0.10%)
    2 / 6950 (0.03%)
    9 / 8758 (0.10%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Humerus fracture
         subjects affected / exposed
    3 / 6950 (0.04%)
    6 / 6950 (0.09%)
    3 / 8758 (0.03%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Jaw fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney contusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Ligament sprain
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Muscle rupture
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Patella fracture
         subjects affected / exposed
    3 / 6950 (0.04%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Pneumothorax traumatic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural pulmonary embolism
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural intestinal perforation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    5 / 6950 (0.07%)
    5 / 6950 (0.07%)
    7 / 8758 (0.08%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory fume inhalation disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Rib fracture
         subjects affected / exposed
    6 / 6950 (0.09%)
    7 / 6950 (0.10%)
    6 / 8758 (0.07%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Skin wound
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
    Snake bite
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    6 / 6950 (0.09%)
    1 / 6950 (0.01%)
    8 / 8758 (0.09%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    9 / 6950 (0.13%)
    6 / 6950 (0.09%)
    9 / 8758 (0.10%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    0 / 2
    Subdural haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
    Synovial rupture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    4 / 8758 (0.05%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    4 / 6950 (0.06%)
    2 / 6950 (0.03%)
    6 / 8758 (0.07%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    Ulna fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound evisceration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Wound haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital cystic kidney disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertrophic cardiomyopathy
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pyloric stenosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal dysplasia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Acute left ventricular failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    21 / 6950 (0.30%)
    28 / 6950 (0.40%)
    25 / 8758 (0.29%)
    40 / 8773 (0.46%)
         occurrences causally related to treatment / all
    1 / 21
    0 / 28
    1 / 25
    0 / 40
         deaths causally related to treatment / all
    0 / 10
    0 / 14
    0 / 10
    0 / 21
    Angina pectoris
         subjects affected / exposed
    13 / 6950 (0.19%)
    6 / 6950 (0.09%)
    13 / 8758 (0.15%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    7 / 6950 (0.10%)
    7 / 6950 (0.10%)
    8 / 8758 (0.09%)
    10 / 8773 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Arrhythmia
         subjects affected / exposed
    5 / 6950 (0.07%)
    9 / 6950 (0.13%)
    9 / 8758 (0.10%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 2
    Arrhythmia supraventricular
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
    Atrial fibrillation
         subjects affected / exposed
    40 / 6950 (0.58%)
    54 / 6950 (0.78%)
    49 / 8758 (0.56%)
    58 / 8773 (0.66%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 54
    0 / 49
    0 / 58
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    0 / 7
    0 / 0
    Atrial flutter
         subjects affected / exposed
    6 / 6950 (0.09%)
    5 / 6950 (0.07%)
    9 / 8758 (0.10%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Atrial tachycardia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Atrioventricular block complete
         subjects affected / exposed
    4 / 6950 (0.06%)
    2 / 6950 (0.03%)
    5 / 8758 (0.06%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    4 / 6950 (0.06%)
    8 / 6950 (0.12%)
    5 / 8758 (0.06%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    23 / 6950 (0.33%)
    17 / 6950 (0.24%)
    28 / 8758 (0.32%)
    20 / 8773 (0.23%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 17
    0 / 28
    0 / 20
         deaths causally related to treatment / all
    0 / 22
    0 / 17
    0 / 27
    0 / 20
    Cardiac disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    51 / 6950 (0.73%)
    57 / 6950 (0.82%)
    64 / 8758 (0.73%)
    72 / 8773 (0.82%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 57
    0 / 64
    0 / 72
         deaths causally related to treatment / all
    0 / 31
    0 / 38
    0 / 37
    0 / 48
    Cardiac failure acute
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    3 / 6950 (0.04%)
    6 / 6950 (0.09%)
    5 / 8758 (0.06%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 4
    Cardiac failure congestive
         subjects affected / exposed
    23 / 6950 (0.33%)
    33 / 6950 (0.47%)
    31 / 8758 (0.35%)
    40 / 8773 (0.46%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 33
    0 / 31
    0 / 40
         deaths causally related to treatment / all
    0 / 9
    0 / 12
    0 / 11
    0 / 14
    Cardiac tamponade
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    3 / 6950 (0.04%)
    5 / 6950 (0.07%)
    3 / 8758 (0.03%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 4
    Cardiogenic shock
         subjects affected / exposed
    6 / 6950 (0.09%)
    2 / 6950 (0.03%)
    6 / 8758 (0.07%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiomyopathy alcoholic
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular deconditioning
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiovascular insufficiency
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Chronotropic incompetence
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cor pulmonale
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    28 / 6950 (0.40%)
    25 / 6950 (0.36%)
    32 / 8758 (0.37%)
    31 / 8773 (0.35%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 25
    0 / 32
    0 / 31
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 3
    Coronary artery insufficiency
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    3 / 6950 (0.04%)
    6 / 6950 (0.09%)
    4 / 8758 (0.05%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diastolic dysfunction
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heart valve incompetence
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Left ventricular failure
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mitral valve stenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    41 / 6950 (0.59%)
    45 / 6950 (0.65%)
    59 / 8758 (0.67%)
    55 / 8773 (0.63%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 45
    0 / 59
    0 / 55
         deaths causally related to treatment / all
    0 / 24
    0 / 26
    0 / 32
    0 / 31
    Myocardial ischaemia
         subjects affected / exposed
    5 / 6950 (0.07%)
    16 / 6950 (0.23%)
    8 / 8758 (0.09%)
    22 / 8773 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 16
    0 / 8
    0 / 22
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 9
    Palpitations
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Sinus arrest
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    5 / 6950 (0.07%)
    6 / 6950 (0.09%)
    6 / 8758 (0.07%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
    Ventricular tachycardia
         subjects affected / exposed
    2 / 6950 (0.03%)
    6 / 6950 (0.09%)
    3 / 8758 (0.03%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amyotrophic lateral sclerosis
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
    Aphasia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Balance disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Basal ganglia infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basilar artery thrombosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Brain stem infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brain stem syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Central nervous system lesion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cerebellar ischaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral artery thrombosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cerebral atrophy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    6 / 6950 (0.09%)
    7 / 6950 (0.10%)
    8 / 8758 (0.09%)
    11 / 8773 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    0 / 6
    0 / 10
    Cerebral infarction
         subjects affected / exposed
    16 / 6950 (0.23%)
    17 / 6950 (0.24%)
    21 / 8758 (0.24%)
    20 / 8773 (0.23%)
         occurrences causally related to treatment / all
    0 / 16
    1 / 17
    0 / 21
    1 / 20
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    0 / 9
    0 / 7
    Cerebral ischaemia
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
    Cerebrospinal fluid leakage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    34 / 6950 (0.49%)
    31 / 6950 (0.45%)
    45 / 8758 (0.51%)
    38 / 8773 (0.43%)
         occurrences causally related to treatment / all
    0 / 34
    1 / 31
    0 / 45
    1 / 38
         deaths causally related to treatment / all
    0 / 11
    0 / 17
    0 / 17
    0 / 19
    Cerebrovascular disorder
         subjects affected / exposed
    3 / 6950 (0.04%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Dementia
         subjects affected / exposed
    4 / 6950 (0.06%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Dementia Alzheimer’s type
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Dementia with Lewy bodies
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic coma
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Dizziness
         subjects affected / exposed
    1 / 6950 (0.01%)
    5 / 6950 (0.07%)
    3 / 8758 (0.03%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Drop attacks
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dural arteriovenous fistula
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dyspraxia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Generalised tonic-clonic seizure
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Guillain-Barre syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 2
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
    Haemorrhagic stroke
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    4 / 8758 (0.05%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Intracranial aneurysm
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    7 / 6950 (0.10%)
    6 / 6950 (0.09%)
    7 / 8758 (0.08%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    0 / 4
    0 / 1
    Lacunar infarction
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Memory impairment
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Miller Fisher syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed dementia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Myasthenia gravis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nerve compression
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuritis cranial
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parkinson’s disease
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Progressive supranuclear palsy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Radiculopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Restless legs syndrome
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ruptured cerebral aneurysm
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Sciatica
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    4 / 8758 (0.05%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Senile dementia
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Somnolence
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal claudication
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Subarachnoid haemorrhage
         subjects affected / exposed
    5 / 6950 (0.07%)
    7 / 6950 (0.10%)
    5 / 8758 (0.06%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    0 / 5
    0 / 2
    Syncope
         subjects affected / exposed
    11 / 6950 (0.16%)
    20 / 6950 (0.29%)
    15 / 8758 (0.17%)
    24 / 8773 (0.27%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 20
    0 / 15
    1 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Thalamic infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thalamus haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Thrombotic cerebral infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Transient global amnesia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    20 / 6950 (0.29%)
    14 / 6950 (0.20%)
    22 / 8758 (0.25%)
    19 / 8773 (0.22%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 14
    0 / 22
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIIIth nerve lesion
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 6950 (0.09%)
    13 / 6950 (0.19%)
    9 / 8758 (0.10%)
    15 / 8773 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
    0 / 9
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Disseminated intravascular coagulation
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersplenism
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune thrombocytopenic purpura
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    7 / 8758 (0.08%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pernicious anaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Ear and labyrinth disorders
    Sudden hearing loss
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    7 / 8758 (0.08%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    7 / 6950 (0.10%)
    7 / 6950 (0.10%)
    7 / 8758 (0.08%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Choroidal effusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iridocele
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Iritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular hypertension
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ocular vascular disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal degeneration
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    0 / 8758 (0.00%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Abdominal discomfort
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    1 / 6950 (0.01%)
    7 / 6950 (0.10%)
    1 / 8758 (0.01%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal prolapse
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Autoimmune pancreatitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Barrett’s oesophagus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic gastritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    3 / 6950 (0.04%)
    1 / 6950 (0.01%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Crohn’s disease
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diaphragmatic hernia, obstructive
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Diverticulum
         subjects affected / exposed
    3 / 6950 (0.04%)
    3 / 6950 (0.04%)
    5 / 8758 (0.06%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Duodenal ulcer
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Faecal incontinence
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    4 / 6950 (0.06%)
    6 / 6950 (0.09%)
    5 / 8758 (0.06%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastric ulcer perforation
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 6950 (0.04%)
    6 / 6950 (0.09%)
    4 / 8758 (0.05%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis alcoholic
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    6 / 6950 (0.09%)
    7 / 6950 (0.10%)
    6 / 8758 (0.07%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    5 / 6950 (0.07%)
    10 / 6950 (0.14%)
    6 / 8758 (0.07%)
    13 / 8773 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 6
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia strangulated
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal congestion
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Intestinal ischaemia
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    6 / 6950 (0.09%)
    6 / 6950 (0.09%)
    7 / 8758 (0.08%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
    Intestinal perforation
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Large intestinal obstruction
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Large intestine polyp
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mesenteric artery embolism
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Mesenteritis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Oesophageal haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal spasm
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Oesophageal ulcer haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 6950 (0.04%)
    8 / 6950 (0.12%)
    5 / 8758 (0.06%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    7 / 8758 (0.08%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 4
    1 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritoneal haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngo-oesophageal diverticulum
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Proctitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal perforation
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal prolapse
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Salivary gland calculus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 6950 (0.03%)
    4 / 6950 (0.06%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Bile duct obstruction
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    3 / 6950 (0.04%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    5 / 6950 (0.07%)
    5 / 6950 (0.07%)
    5 / 8758 (0.06%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis
         subjects affected / exposed
    7 / 6950 (0.10%)
    15 / 6950 (0.22%)
    7 / 8758 (0.08%)
    18 / 8773 (0.21%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 15
    0 / 7
    0 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    7 / 6950 (0.10%)
    4 / 6950 (0.06%)
    8 / 8758 (0.09%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    14 / 6950 (0.20%)
    14 / 6950 (0.20%)
    14 / 8758 (0.16%)
    17 / 8773 (0.19%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
    0 / 14
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Chronic hepatic failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Cirrhosis alcoholic
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gallbladder perforation
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Hepatic cirrhosis
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Hepatic failure
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 2
    Hepatic function abnormal
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Jaundice cholestatic
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Dermal cyst
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatitis contact
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dermatomyositis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    0 / 6950 (0.00%)
    5 / 6950 (0.07%)
    0 / 8758 (0.00%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Drug eruption
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukoplakia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lichen planus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    18 / 6950 (0.26%)
    19 / 6950 (0.27%)
    23 / 8758 (0.26%)
    22 / 8773 (0.25%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 19
    0 / 23
    0 / 22
         deaths causally related to treatment / all
    0 / 8
    0 / 7
    0 / 12
    0 / 7
    Acute prerenal failure
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder perforation
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bladder prolapse
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    4 / 6950 (0.06%)
    11 / 6950 (0.16%)
    4 / 8758 (0.05%)
    13 / 8773 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
    0 / 4
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 4
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cystitis interstitial
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    4 / 8758 (0.05%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephroangiosclerosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    6 / 6950 (0.09%)
    2 / 6950 (0.03%)
    6 / 8758 (0.07%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neurogenic bladder
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal artery occlusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    11 / 6950 (0.16%)
    11 / 6950 (0.16%)
    11 / 8758 (0.13%)
    14 / 8773 (0.16%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    0 / 7
    0 / 5
    Renal hypertension
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal mass
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    4 / 6950 (0.06%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Urethral meatus stenosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Urinary retention
         subjects affected / exposed
    3 / 6950 (0.04%)
    3 / 6950 (0.04%)
    4 / 8758 (0.05%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Basedow’s disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cushingoid
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperparathyroidism primary
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypopituitarism
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Acquired claw toe
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthrofibrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 6950 (0.03%)
    5 / 6950 (0.07%)
    2 / 8758 (0.02%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meniscal degeneration
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Mixed connective tissue disease
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    26 / 6950 (0.37%)
    17 / 6950 (0.24%)
    30 / 8758 (0.34%)
    20 / 8773 (0.23%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 17
    0 / 30
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondritis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    5 / 6950 (0.07%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 4
    0 / 6
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Pseudarthrosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Rheumatoid arthritis
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sjogren’s syndrome
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    6 / 6950 (0.09%)
    6 / 6950 (0.09%)
    7 / 8758 (0.08%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal disorder
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    3 / 6950 (0.04%)
    5 / 6950 (0.07%)
    3 / 8758 (0.03%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Still’s disease adult onset
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Systemic lupus erythematosus
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tenosynovitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Trigger finger
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcaligenes infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal fistula infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anorectal cellulitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    5 / 6950 (0.07%)
    5 / 6950 (0.07%)
    6 / 8758 (0.07%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arteriosclerotic gangrene
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
    Bacteriuria
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Biliary tract infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 6950 (0.12%)
    7 / 6950 (0.10%)
    10 / 8758 (0.11%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
    Bronchitis bacterial
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 6950 (0.01%)
    4 / 6950 (0.06%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
    Candida infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Candiduria
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cavernous sinus thrombosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    8 / 6950 (0.12%)
    14 / 6950 (0.20%)
    11 / 8758 (0.13%)
    16 / 8773 (0.18%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 14
    0 / 11
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Cholecystitis infective
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium bacteraemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    5 / 6950 (0.07%)
    1 / 8758 (0.01%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
    Colonic abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Cystitis
         subjects affected / exposed
    4 / 6950 (0.06%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cystitis klebsiella
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    5 / 6950 (0.07%)
    11 / 6950 (0.16%)
    5 / 8758 (0.06%)
    13 / 8773 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 11
    0 / 5
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    Empyema
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalitis viral
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Endocarditis
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    4 / 8758 (0.05%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Enterocolitis viral
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    3 / 6950 (0.04%)
    7 / 6950 (0.10%)
    4 / 8758 (0.05%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 7
    1 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Escherichia infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fungaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    8 / 6950 (0.12%)
    8 / 6950 (0.12%)
    9 / 8758 (0.10%)
    8 / 8773 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Helicobacter gastritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    1 / 8758 (0.01%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster disseminated
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster meningitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incision site infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Infectious colitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Intestinal gangrene
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kidney infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Labyrinthitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    2 / 6950 (0.03%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    4 / 6950 (0.06%)
    8 / 6950 (0.12%)
    4 / 8758 (0.05%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
    Localised infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    2 / 8758 (0.02%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
    0 / 1
    Medical device site infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Necrotising fasciitis streptococcal
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Neuroborreliosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Oropharyngeal candidiasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatic abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    4 / 6950 (0.06%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    5 / 8773 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    0 / 5
    0 / 2
    Peritonitis bacterial
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    70 / 6950 (1.01%)
    81 / 6950 (1.17%)
    96 / 8758 (1.10%)
    93 / 8773 (1.06%)
         occurrences causally related to treatment / all
    0 / 70
    0 / 81
    0 / 96
    0 / 93
         deaths causally related to treatment / all
    0 / 24
    0 / 38
    0 / 34
    0 / 42
    Pneumonia bacterial
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Postoperative abscess
         subjects affected / exposed
    3 / 6950 (0.04%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    Pseudomonas infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psittacosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    Psoas abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Purulence
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    3 / 6950 (0.04%)
    4 / 6950 (0.06%)
    5 / 8758 (0.06%)
    6 / 8773 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 6950 (0.06%)
    0 / 6950 (0.00%)
    5 / 8758 (0.06%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory moniliasis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    3 / 6950 (0.04%)
    3 / 8758 (0.03%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    26 / 6950 (0.37%)
    17 / 6950 (0.24%)
    32 / 8758 (0.37%)
    26 / 8773 (0.30%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 17
    0 / 32
    0 / 26
         deaths causally related to treatment / all
    0 / 16
    0 / 11
    0 / 21
    0 / 16
    Septic shock
         subjects affected / exposed
    11 / 6950 (0.16%)
    14 / 6950 (0.20%)
    11 / 8758 (0.13%)
    16 / 8773 (0.18%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 14
    0 / 11
    0 / 16
         deaths causally related to treatment / all
    0 / 10
    0 / 12
    0 / 10
    0 / 13
    Sinusitis
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Soft tissue infection
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    4 / 6950 (0.06%)
    1 / 6950 (0.01%)
    5 / 8758 (0.06%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Staphylococcal osteomyelitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal sepsis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Testicular abscess
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    28 / 6950 (0.40%)
    24 / 6950 (0.35%)
    33 / 8758 (0.38%)
    30 / 8773 (0.34%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 24
    0 / 33
    0 / 30
         deaths causally related to treatment / all
    0 / 2
    0 / 6
    0 / 4
    0 / 6
    Urinary tract infection bacterial
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    2 / 8758 (0.02%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    7 / 6950 (0.10%)
    9 / 6950 (0.13%)
    8 / 8758 (0.09%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    0 / 1
    0 / 3
    Vestibular neuronitis
         subjects affected / exposed
    0 / 6950 (0.00%)
    3 / 6950 (0.04%)
    0 / 8758 (0.00%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Viral sepsis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vulvitis
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    3 / 6950 (0.04%)
    2 / 6950 (0.03%)
    3 / 8758 (0.03%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    2 / 6950 (0.03%)
    2 / 6950 (0.03%)
    2 / 8758 (0.02%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    0 / 2
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    8 / 6950 (0.12%)
    8 / 6950 (0.12%)
    12 / 8758 (0.14%)
    10 / 8773 (0.11%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    2 / 6950 (0.03%)
    3 / 6950 (0.04%)
    2 / 8758 (0.02%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    1 / 8758 (0.01%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    0 / 8758 (0.00%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 2
    Gout
         subjects affected / exposed
    2 / 6950 (0.03%)
    0 / 6950 (0.00%)
    3 / 8758 (0.03%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    2 / 8773 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 6950 (0.01%)
    1 / 6950 (0.01%)
    3 / 8758 (0.03%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    6 / 6950 (0.09%)
    4 / 6950 (0.06%)
    6 / 8758 (0.07%)
    4 / 8773 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    7 / 6950 (0.10%)
    2 / 6950 (0.03%)
    9 / 8758 (0.10%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    2 / 6950 (0.03%)
    5 / 6950 (0.07%)
    3 / 8758 (0.03%)
    7 / 8773 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    1 / 6950 (0.01%)
    0 / 6950 (0.00%)
    1 / 8758 (0.01%)
    0 / 8773 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Ketoacidosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 6950 (0.01%)
    2 / 6950 (0.03%)
    1 / 8758 (0.01%)
    3 / 8773 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 1
    Marasmus
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Metabolic acidosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Type 2 diabetes mellitus
         subjects affected / exposed
    5 / 6950 (0.07%)
    6 / 6950 (0.09%)
    6 / 8758 (0.07%)
    9 / 8773 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Uraemic acidosis
         subjects affected / exposed
    0 / 6950 (0.00%)
    1 / 6950 (0.01%)
    0 / 8758 (0.00%)
    1 / 8773 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Zoster-022 GSK1437173A Group Zoster-022 Placebo Group Zoster-022/006 Pooled GSK1437173A Group Zoster-022/006 Pooled Placebo Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4080 / 6950 (58.71%)
    853 / 6950 (12.27%)
    5543 / 8758 (63.29%)
    3027 / 8773 (34.50%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    586 / 6950 (8.43%)
    243 / 6950 (3.50%)
    1118 / 8758 (12.77%)
    464 / 8773 (5.29%)
         occurrences all number
    717
    307
    1413
    573
    General disorders and administration site conditions
    Chills
         subjects affected / exposed
    353 / 6950 (5.08%)
    39 / 6950 (0.56%)
    718 / 8758 (8.20%)
    128 / 8773 (1.46%)
         occurrences all number
    415
    46
    862
    147
    Fatigue
         subjects affected / exposed
    474 / 6950 (6.82%)
    169 / 6950 (2.43%)
    1135 / 8758 (12.96%)
    420 / 8773 (4.79%)
         occurrences all number
    592
    192
    1494
    501
    Injection site erythema
         subjects affected / exposed
    864 / 6950 (12.43%)
    27 / 6950 (0.39%)
    872 / 8758 (9.96%)
    27 / 8773 (0.31%)
         occurrences all number
    1150
    29
    1162
    29
    Injection site pain
         subjects affected / exposed
    1975 / 6950 (28.42%)
    148 / 6950 (2.13%)
    1990 / 8758 (22.72%)
    153 / 8773 (1.74%)
         occurrences all number
    2762
    165
    2783
    170
    Injection site swelling
         subjects affected / exposed
    613 / 6950 (8.82%)
    16 / 6950 (0.23%)
    616 / 8758 (7.03%)
    16 / 8773 (0.18%)
         occurrences all number
    773
    18
    776
    18
    Pain
         subjects affected / exposed
    428 / 6950 (6.16%)
    60 / 6950 (0.86%)
    1644 / 8758 (18.77%)
    217 / 8773 (2.47%)
         occurrences all number
    669
    67
    2670
    254
    Pyrexia
         subjects affected / exposed
    535 / 6950 (7.70%)
    52 / 6950 (0.75%)
    800 / 8758 (9.13%)
    102 / 8773 (1.16%)
         occurrences all number
    633
    56
    926
    107
    Swelling
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    521 / 8758 (5.95%)
    25 / 8773 (0.28%)
         occurrences all number
    0
    0
    701
    27
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 6950 (0.00%)
    0 / 6950 (0.00%)
    871 / 8758 (9.95%)
    44 / 8773 (0.50%)
         occurrences all number
    0
    0
    1208
    49
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    378 / 6950 (5.44%)
    99 / 6950 (1.42%)
    1017 / 8758 (11.61%)
    286 / 8773 (3.26%)
         occurrences all number
    472
    113
    1413
    343

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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