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    Clinical Trial Results:
    Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure (DAPA-HF)

    Summary
    EudraCT number
    		 2016-003897-41
    Trial protocol
    		 SE   CZ   DE   DK   BG   SK   PL  
    Global end of trial date
    17 Jul 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2020
    First version publication date
    22 Jul 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D1699C00001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03036124
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    AstraZeneca Information Centre, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Jul 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event (hospitalisation for HF or equivalent HF event, i.e., an urgent HF visit).
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Feb 2017
    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
    China: 237
    Country: Number of subjects enrolled
    India: 237
    Country: Number of subjects enrolled
    Japan: 343
    Country: Number of subjects enrolled
    Taiwan: 141
    Country: Number of subjects enrolled
    Vietnam: 138
    Country: Number of subjects enrolled
    Bulgaria: 266
    Country: Number of subjects enrolled
    Czech Republic: 210
    Country: Number of subjects enrolled
    Denmark: 99
    Country: Number of subjects enrolled
    Germany: 186
    Country: Number of subjects enrolled
    Hungary: 250
    Country: Number of subjects enrolled
    Netherlands: 135
    Country: Number of subjects enrolled
    Poland: 290
    Country: Number of subjects enrolled
    Russian Federation: 422
    Country: Number of subjects enrolled
    Slovakia: 166
    Country: Number of subjects enrolled
    Sweden: 68
    Country: Number of subjects enrolled
    United Kingdom: 62
    Country: Number of subjects enrolled
    Canada: 223
    Country: Number of subjects enrolled
    United States: 454
    Country: Number of subjects enrolled
    Argentina: 297
    Country: Number of subjects enrolled
    Brazil: 520
    Worldwide total number of subjects
    4744
    EEA total number of subjects
    1732
    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)
    1878
    From 65 to 84 years
    2745
    85 years and over
    121

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 In DAPA-HFat the first visit, i.e. the enrollment visit 1, patients were evaluated regarding the protocol mandated inclusion and exclusion criteria.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Dapa 10mg
    Arm description
    		 Dapagliflozin 10 mg tablets administered orally once daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Dapagliflozin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Dapagliflozin 10 mg tablets administered orally once daily

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo for dapagliflozin 10 mg administered orally once daily
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Matching placebo for dapagliflozin 10 mg administered orally once daily

    Number of subjects in period 1
    		Dapa 10mg Placebo
    Started
    2373
    2371
    Completed
    2368
    2365
    Not completed
    5
    6
         Consent withdrawn by subject
    5
    4
         Lost to follow-up
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dapa 10mg
    Reporting group description
    		 Dapagliflozin 10 mg tablets administered orally once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo for dapagliflozin 10 mg administered orally once daily

    Reporting group values
    		 Dapa 10mg Placebo Total
    Number of subjects
    		 2373 2371 4744
    Age Categorical
    Units: Participants
        <=50
    		 208 188 396
        >50
    		 2165 2183 4348
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 66.2 ( 11.0 ) 66.5 ( 10.8 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 564 545 1109
        Male
    		 1809 1826 3635
    Age, Customized
    Units: Subjects
        <=65
    		 1032 998 2030
        66 - 75
    		 825 886 1711
        >75
    		 516 487 1003
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 1662 1671 3333
        Black or African American
    		 122 104 226
        Asian
    		 552 564 1116
        Native Hawaiian or other Pacific Islander
    		 0 2 2
        American Indian or Alaska Native
    		 3 1 4
        Other
    		 34 29 63
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 381 387 768
        Not Hispanic or Latino
    		 1992 1984 3976
        Unknown or Not Reported
    		 0 0 0
    Main etiology of HF
    Units: Subjects
        Ischaemic
    		 1316 1358 2674
        Non-Ischaemic
    		 857 830 1687
        Unknown
    		 200 183 383
    Prior HF hospitalization
    Units: Subjects
        Yes
    		 1124 1127 2251
        No
    		 1249 1244 2493
    NYHA class at enrolment
    Units: Subjects
        II
    		 1606 1597 3203
        III
    		 747 751 1498
        IV
    		 20 23 43
    Type 2 diabetes at baseline
    Units: Subjects
        Yes
    		 1075 1064 2139
        No
    		 1298 1307 2605
    LVEF
    Units: Percent
        arithmetic mean (standard deviation)
    		 31.2 ( 6.7 ) 30.9 ( 6.9 ) -
    Subject analysis sets

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects.

    Subject analysis sets values
    		 Full Analysis Set
    Number of subjects
    4744
    Age Categorical
    Units: Participants
        <=50
    396
        >50
    4348
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    66.3 ( 10.9 )
    Sex: Female, Male
    Units: Participants
        Female
        Male
    Age, Customized
    Units: Subjects
        <=65
        66 - 75
        >75
    Race/Ethnicity, Customized
    Units: Subjects
        White
        Black or African American
        Asian
        Native Hawaiian or other Pacific Islander
        American Indian or Alaska Native
        Other
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
        Not Hispanic or Latino
        Unknown or Not Reported
    Main etiology of HF
    Units: Subjects
        Ischaemic
        Non-Ischaemic
        Unknown
    Prior HF hospitalization
    Units: Subjects
        Yes
        No
    NYHA class at enrolment
    Units: Subjects
        II
        III
        IV
    Type 2 diabetes at baseline
    Units: Subjects
        Yes
        No
    LVEF
    Units: Percent
        arithmetic mean (standard deviation)
    31.1 ( 6.8 )

    End points

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    End points reporting groups
    Reporting group title
    Dapa 10mg
    Reporting group description
    		 Dapagliflozin 10 mg tablets administered orally once daily

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo for dapagliflozin 10 mg administered orally once daily

    Subject analysis set title
    Full Analysis Set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All randomized subjects.

    Primary: Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.

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    End point title
    		 Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure.
    End point description
    Primary efficacy
    End point type
    Primary
    End point timeframe
    Up to 27.8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2373
    2371
    2373
    Units: Participants
    386
    502
    386
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Dapa 10mg v Placebo v Full Analysis Set
    Number of subjects included in analysis
    7117
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.85

    Secondary: Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.

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    End point title
    		 Subjects Included in the Composite Endpoint of CV Death or Hospitalization Due to Heart Failure.
    End point description
    Secondary
    End point type
    Secondary
    End point timeframe
    Up to 27.8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2373
    2371
    2373
    Units: Participants
    382
    495
    382
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Placebo v Full Analysis Set
    Number of subjects included in analysis
    4744
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.85

    Secondary: Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.

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    End point title
    		 Events Included in the Composite Endpoint of Recurrent Hospitalizations Due to Heart Failure and CV Death.
    End point description
    Secondary
    End point type
    Secondary
    End point timeframe
    Up to 27.8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2373
    2371
    2373
    Units: HF events or CVD.
    567
    742
    567
    Statistical analysis title
    		 Recurrent event analysis
    Comparison groups
    Placebo v Full Analysis Set
    Number of subjects included in analysis
    4744
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 LWYY proportional rates model
    Parameter type
    		 Rate Ratio (RR)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.88

    Secondary: Change from baseline in the KCCQ total symptom score

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    End point title
    		 Change from baseline in the KCCQ total symptom score
    End point description
    Secondary
    End point type
    Secondary
    End point timeframe
    8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2373
    2371
    2373
    Units: 1-point in the scale of 0 to 100.
    2252
    2235
    2252
    Statistical analysis title
    		 Win ratio analysis
    Comparison groups
    Placebo v Full Analysis Set
    Number of subjects included in analysis
    4744
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Win Ratio
    Parameter type
    		 Win Ratio (WR)
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.26
    Notes
    [1] - The p-value is obtained from a rank ANCOVA adjusted for baseline KCCQ score and stratified by T2DM status at randomization.

    Secondary: Subjects Included in the Composite Endpoint of ≥50% sustained decline in eGFR, ESRD or Renal death.

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    End point title
    		 Subjects Included in the Composite Endpoint of ≥50% sustained decline in eGFR, ESRD or Renal death.
    End point description
    Secondary
    End point type
    Secondary
    End point timeframe
    Up to 27.8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2371
    2371
    2373
    Units: Participants
    28
    39
    28
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Placebo v Full Analysis Set
    Number of subjects included in analysis
    4744
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1681
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 1.16

    Secondary: Subjects Included in the Endpoint of All-cause Mortality.

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    End point title
    		 Subjects Included in the Endpoint of All-cause Mortality.
    End point description
    Secondary
    End point type
    Secondary
    End point timeframe
    Up to 27.8 months.
    End point values
    		 Dapa 10mg Placebo Full Analysis Set
    Number of subjects analysed
    2373
    2371
    2373
    Units: Participants
    276
    329
    276
    Statistical analysis title
    		 Cox regression
    Comparison groups
    Placebo v Full Analysis Set
    Number of subjects included in analysis
    4744
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0217
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.97

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug until last study visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    Dapa 10mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Dapa 10mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    895 / 2368 (37.80%)
    994 / 2368 (41.98%)
         number of deaths (all causes)
    287
    335
         number of deaths resulting from adverse events
    286
    333
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basal cell carcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign uterine neoplasm
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer female
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer recurrent
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brenner tumour
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer metastatic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal adenocarcinoma of pancreas
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric cancer
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal cancer metastatic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Leukaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Leukaemia recurrent
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    6 / 2368 (0.25%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Malignant melanoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic carcinoma of the bladder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelofibrosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal cavity cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary renal cell carcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour benign
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleomorphic adenoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    6 / 2368 (0.25%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Squamous cell carcinoma
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tonsil cancer
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic dissection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic vascular disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential hypertension
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocoele
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    7 / 2368 (0.30%)
    11 / 2368 (0.46%)
         occurrences causally related to treatment / all
    1 / 9
    4 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    11 / 2368 (0.46%)
    10 / 2368 (0.42%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    9 / 2368 (0.38%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Chest discomfort
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    4 / 2368 (0.17%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    48 / 2368 (2.03%)
    48 / 2368 (2.03%)
         occurrences causally related to treatment / all
    0 / 48
    1 / 48
         deaths causally related to treatment / all
    0 / 48
    1 / 48
    General physical health deterioration
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site inflammation
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Necrosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    6 / 2368 (0.25%)
    16 / 2368 (0.68%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sudden cardiac death
         subjects affected / exposed
    18 / 2368 (0.76%)
    27 / 2368 (1.14%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 27
         deaths causally related to treatment / all
    0 / 18
    0 / 27
    Sudden death
         subjects affected / exposed
    19 / 2368 (0.80%)
    10 / 2368 (0.42%)
         occurrences causally related to treatment / all
    2 / 19
    0 / 10
         deaths causally related to treatment / all
    2 / 19
    0 / 10
    Ulcer haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent occlusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Heart transplant rejection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenomyosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    5 / 2368 (0.21%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis noninfective
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    7 / 2368 (0.30%)
    14 / 2368 (0.59%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Aspiration
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    14 / 2368 (0.59%)
    22 / 2368 (0.93%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic respiratory failure
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 2368 (0.17%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilic pneumonia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cyst
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal lesion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pleurisy
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia aspiration
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pneumonitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax spontaneous
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    7 / 2368 (0.30%)
    14 / 2368 (0.59%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 14
         deaths causally related to treatment / all
    0 / 3
    1 / 6
    Pulmonary hypertension
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    3 / 2368 (0.13%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary toxicity
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary vasculitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    3 / 2368 (0.13%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Psychiatric disorders
    Alcohol withdrawal syndrome
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Confusional state
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device dislocation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device inappropriate shock delivery
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device lead issue
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular filtration rate decreased
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial pressure increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone contusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain herniation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    7 / 2368 (0.30%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound complication
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Skin injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    4 / 2368 (0.17%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tendon injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    5 / 2368 (0.21%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    37 / 2368 (1.56%)
    38 / 2368 (1.60%)
         occurrences causally related to treatment / all
    1 / 37
    1 / 40
         deaths causally related to treatment / all
    1 / 11
    0 / 9
    Angina pectoris
         subjects affected / exposed
    12 / 2368 (0.51%)
    12 / 2368 (0.51%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    21 / 2368 (0.89%)
    30 / 2368 (1.27%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 2368 (0.08%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    26 / 2368 (1.10%)
    39 / 2368 (1.65%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Atrial flutter
         subjects affected / exposed
    8 / 2368 (0.34%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    2 / 2368 (0.08%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    9 / 2368 (0.38%)
    10 / 2368 (0.42%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 6
    0 / 7
    Cardiac disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    262 / 2368 (11.06%)
    351 / 2368 (14.82%)
         occurrences causally related to treatment / all
    8 / 380
    8 / 523
         deaths causally related to treatment / all
    0 / 53
    1 / 76
    Cardiac failure acute
         subjects affected / exposed
    42 / 2368 (1.77%)
    59 / 2368 (2.49%)
         occurrences causally related to treatment / all
    1 / 58
    3 / 75
         deaths causally related to treatment / all
    0 / 11
    0 / 13
    Cardiac failure chronic
         subjects affected / exposed
    27 / 2368 (1.14%)
    33 / 2368 (1.39%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 46
         deaths causally related to treatment / all
    0 / 8
    0 / 9
    Cardiac failure congestive
         subjects affected / exposed
    65 / 2368 (2.74%)
    70 / 2368 (2.96%)
         occurrences causally related to treatment / all
    2 / 102
    4 / 106
         deaths causally related to treatment / all
    1 / 9
    0 / 13
    Cardiac tamponade
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiogenic shock
         subjects affected / exposed
    9 / 2368 (0.38%)
    15 / 2368 (0.63%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 16
         deaths causally related to treatment / all
    0 / 6
    0 / 11
    Cardiomyopathy
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiorenal syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    9 / 2368 (0.38%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Coronary artery stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frederick's syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Low cardiac output syndrome
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    16 / 2368 (0.68%)
    17 / 2368 (0.72%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 17
         deaths causally related to treatment / all
    0 / 7
    0 / 7
    Myocardial ischaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Palpitations
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic cardiac valve thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    6 / 2368 (0.25%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    11 / 2368 (0.46%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Ventricular tachyarrhythmia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    34 / 2368 (1.44%)
    54 / 2368 (2.28%)
         occurrences causally related to treatment / all
    1 / 41
    1 / 65
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Nervous system disorders
    Brain injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain stem infarction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar stroke
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    8 / 2368 (0.34%)
    11 / 2368 (0.46%)
         occurrences causally related to treatment / all
    2 / 9
    1 / 12
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cerebral thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    7 / 2368 (0.30%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Diabetic ketoacidotic hyperglycaemic coma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dizziness
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised tonic-clonic seizure
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Haemorrhagic transformation stroke
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Headache
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    24 / 2368 (1.01%)
    26 / 2368 (1.10%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 28
         deaths causally related to treatment / all
    0 / 4
    0 / 6
    Loss of consciousness
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    7 / 2368 (0.30%)
    13 / 2368 (0.55%)
         occurrences causally related to treatment / all
    1 / 7
    4 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    13 / 2368 (0.55%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular dementia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vascular encephalopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IIIrd nerve paresis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    11 / 2368 (0.46%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Angle closure glaucoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    4 / 2368 (0.17%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic ischaemic neuropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strabismus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic gastritis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 2368 (0.17%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiectasia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    4 / 2368 (0.17%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal obstruction
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal polyp haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal ulcer
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    9 / 2368 (0.38%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    6 / 2368 (0.25%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis mesenteric vessel
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct obstruction
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    3 / 2368 (0.13%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    6 / 2368 (0.25%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cholecystitis chronic
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cryptogenic cirrhosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder enlargement
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug eruption
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin necrosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    23 / 2368 (0.97%)
    46 / 2368 (1.94%)
         occurrences causally related to treatment / all
    2 / 25
    5 / 49
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Anuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neck obstruction
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    4 / 2368 (0.17%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis noninfective
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    8 / 2368 (0.34%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    1 / 8
    1 / 9
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Renal impairment
         subjects affected / exposed
    7 / 2368 (0.30%)
    13 / 2368 (0.55%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis reactive
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    5 / 2368 (0.21%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis of jaw
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mass
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Biliary sepsis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    12 / 2368 (0.51%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis infective
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    9 / 2368 (0.38%)
    10 / 2368 (0.42%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis gangrenous
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridial infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated tuberculosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Diverticulitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis bacterial
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endotoxic shock
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Furuncle
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastroenteritis
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster oticus
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Infectious pleural effusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal sepsis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    4 / 2368 (0.17%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lyme disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device site infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal candidiasis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    7 / 2368 (0.30%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perichondritis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Peritonsillar abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    76 / 2368 (3.21%)
    82 / 2368 (3.46%)
         occurrences causally related to treatment / all
    0 / 83
    1 / 87
         deaths causally related to treatment / all
    0 / 9
    0 / 8
    Pneumonia bacterial
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelocystitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 2368 (0.13%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rickettsiosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    13 / 2368 (0.55%)
    14 / 2368 (0.59%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 14
         deaths causally related to treatment / all
    1 / 5
    0 / 6
    Septic shock
         subjects affected / exposed
    8 / 2368 (0.34%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Sinusitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic candida
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    11 / 2368 (0.46%)
    17 / 2368 (0.72%)
         occurrences causally related to treatment / all
    7 / 13
    4 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urinary tract infection staphylococcal
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    4 / 2368 (0.17%)
    7 / 2368 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    5 / 2368 (0.21%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIV infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Cachexia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    10 / 2368 (0.42%)
    8 / 2368 (0.34%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    5 / 2368 (0.21%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    6 / 2368 (0.25%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid retention
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Steroid diabetes
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Dapa 10mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    928 / 2368 (39.19%)
    955 / 2368 (40.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Anogenital warts
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Benign lung neoplasm
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Bladder cancer
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Bowen's disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Colon adenoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cutaneous T-cell lymphoma recurrent
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    2
    Colon cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Lipoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Eyelid tumour
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Lung neoplasm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Prostate cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Renal cancer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic keratosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Thyroid adenoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Uterine leiomyoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypotension
         subjects affected / exposed
    88 / 2368 (3.72%)
    73 / 2368 (3.08%)
         occurrences all number
    98
    81
    Accelerated hypertension
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Aortic dilatation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Aortic aneurysm
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Aortic stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Aortic thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Arterial stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Deep vein thrombosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Circulatory collapse
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Dry gangrene
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    1
    4
    Flushing
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    17 / 2368 (0.72%)
    19 / 2368 (0.80%)
         occurrences all number
    19
    21
    Hypertensive crisis
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Hypertensive urgency
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hypovolaemic shock
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Intermittent claudication
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Lymphatic fistula
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Orthostatic hypotension
         subjects affected / exposed
    10 / 2368 (0.42%)
    5 / 2368 (0.21%)
         occurrences all number
    10
    5
    Peripheral arterial occlusive disease
         subjects affected / exposed
    7 / 2368 (0.30%)
    3 / 2368 (0.13%)
         occurrences all number
    7
    3
    Peripheral artery occlusion
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Peripheral artery stenosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Peripheral coldness
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Peripheral embolism
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Peripheral ischaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Peripheral venous disease
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Phlebitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Poor peripheral circulation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Raynaud's phenomenon
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Subclavian artery stenosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Subclavian vein thrombosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Varicose ulceration
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Varicose vein
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Vasculitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Administration site phlebitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Asthenia
         subjects affected / exposed
    7 / 2368 (0.30%)
    4 / 2368 (0.17%)
         occurrences all number
    7
    4
    Catheter site pain
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Chest discomfort
         subjects affected / exposed
    5 / 2368 (0.21%)
    5 / 2368 (0.21%)
         occurrences all number
    5
    5
    Chest pain
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences all number
    4
    4
    Chills
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Complication associated with device
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Disuse syndrome
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Drug intolerance
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Fatigue
         subjects affected / exposed
    15 / 2368 (0.63%)
    11 / 2368 (0.46%)
         occurrences all number
    15
    12
    Feeling abnormal
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Gait disturbance
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Hernia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Impaired healing
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Implant site extravasation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Infusion site extravasation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    6 / 2368 (0.25%)
    4 / 2368 (0.17%)
         occurrences all number
    6
    4
    Medical device site haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Medical device site pain
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Non-cardiac chest pain
         subjects affected / exposed
    5 / 2368 (0.21%)
    4 / 2368 (0.17%)
         occurrences all number
    5
    4
    Oedema
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Oedema peripheral
         subjects affected / exposed
    13 / 2368 (0.55%)
    29 / 2368 (1.22%)
         occurrences all number
    14
    31
    Pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Peripheral swelling
         subjects affected / exposed
    5 / 2368 (0.21%)
    8 / 2368 (0.34%)
         occurrences all number
    5
    8
    Pyrexia
         subjects affected / exposed
    1 / 2368 (0.04%)
    11 / 2368 (0.46%)
         occurrences all number
    1
    12
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Thirst
         subjects affected / exposed
    5 / 2368 (0.21%)
    0 / 2368 (0.00%)
         occurrences all number
    5
    0
    Immune system disorders
    Contrast media allergy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Drug hypersensitivity
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Hypersensitivity
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Reproductive system and breast disorders
    Acquired hydrocele
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Acquired phimosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Balanoposthitis
         subjects affected / exposed
    8 / 2368 (0.34%)
    1 / 2368 (0.04%)
         occurrences all number
    10
    1
    Benign prostatic hyperplasia
         subjects affected / exposed
    7 / 2368 (0.30%)
    9 / 2368 (0.38%)
         occurrences all number
    7
    9
    Erectile dysfunction
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Genital haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gynaecomastia
         subjects affected / exposed
    4 / 2368 (0.17%)
    8 / 2368 (0.34%)
         occurrences all number
    4
    8
    Pelvic pain
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Penile oedema
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Pruritus genital
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Scrotal haematocoele
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Vulvar erosion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Asthma
         subjects affected / exposed
    4 / 2368 (0.17%)
    2 / 2368 (0.08%)
         occurrences all number
    4
    3
    Bronchial disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Bronchitis chronic
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    6 / 2368 (0.25%)
    10 / 2368 (0.42%)
         occurrences all number
    7
    12
    Cough
         subjects affected / exposed
    14 / 2368 (0.59%)
    18 / 2368 (0.76%)
         occurrences all number
    16
    19
    Dysphonia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    20 / 2368 (0.84%)
    33 / 2368 (1.39%)
         occurrences all number
    22
    35
    Dyspnoea exertional
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 2368 (0.00%)
    4 / 2368 (0.17%)
         occurrences all number
    0
    4
    Emphysema
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Epistaxis
         subjects affected / exposed
    8 / 2368 (0.34%)
    8 / 2368 (0.34%)
         occurrences all number
    9
    8
    Haemoptysis
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    1
    4
    Hiccups
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Nasal polyps
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Obstructive airways disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Pleural effusion
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences all number
    2
    6
    Pleural fibrosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pleural thickening
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pleurisy
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Pneumonia aspiration
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Pneumothorax
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Productive cough
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Pulmonary calcification
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Pulmonary congestion
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    1
    4
    Pulmonary embolism
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Pulmonary hypertension
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Pulmonary mass
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Pulmonary oedema
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Respiratory disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Respiratory failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Rhinitis allergic
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Rhinorrhoea
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences all number
    3
    3
    Tachypnoea
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Throat irritation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Upper respiratory tract inflammation
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences all number
    2
    7
    Wheezing
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Adjustment disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Adjustment disorder with depressed mood
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Affective disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Anxiety
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences all number
    4
    6
    Confusional state
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Delirium
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences all number
    3
    7
    Depressed mood
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Depression
         subjects affected / exposed
    5 / 2368 (0.21%)
    6 / 2368 (0.25%)
         occurrences all number
    5
    6
    Disorientation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Emotional disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Insomnia
         subjects affected / exposed
    9 / 2368 (0.38%)
    12 / 2368 (0.51%)
         occurrences all number
    10
    12
    Intensive care unit delirium
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Mental status changes
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    2
    Organic brain syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Panic reaction
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Sleep disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Product issues
    Device battery issue
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Device malfunction
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Investigations
    Acinetobacter test positive
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Bleeding time prolonged
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Blood creatine increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Blood creatinine increased
         subjects affected / exposed
    24 / 2368 (1.01%)
    25 / 2368 (1.06%)
         occurrences all number
    27
    26
    Blood glucose increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Blood potassium decreased
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Blood potassium increased
         subjects affected / exposed
    11 / 2368 (0.46%)
    1 / 2368 (0.04%)
         occurrences all number
    12
    1
    Blood pressure decreased
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Blood pressure increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Blood urea increased
         subjects affected / exposed
    9 / 2368 (0.38%)
    5 / 2368 (0.21%)
         occurrences all number
    9
    5
    Blood uric acid increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Brain natriuretic peptide increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    C-reactive protein increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    5 / 2368 (0.21%)
         occurrences all number
    3
    5
    Candida test positive
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cardiac murmur
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cardioactive drug level increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cardiovascular evaluation
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Coagulation time shortened
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ejection fraction decreased
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Eosinophil count increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate abnormal
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate decreased
         subjects affected / exposed
    15 / 2368 (0.63%)
    21 / 2368 (0.89%)
         occurrences all number
    16
    22
    Glycosylated haemoglobin increased
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    3
    2
    Haematocrit increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Heart rate increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Helicobacter test positive
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Hepatic enzyme increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    International normalised ratio increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    1
    4
    Intraocular pressure increased
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Liver function test increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Low density lipoprotein increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    N-terminal prohormone brain natriuretic peptide increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences all number
    2
    4
    Occult blood positive
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Oxygen saturation decreased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Platelet count decreased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Renal function test abnormal
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Transaminases increased
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Urine analysis abnormal
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Vitamin B12 decreased
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Weight decreased
         subjects affected / exposed
    4 / 2368 (0.17%)
    6 / 2368 (0.25%)
         occurrences all number
    4
    6
    Weight increased
         subjects affected / exposed
    2 / 2368 (0.08%)
    10 / 2368 (0.42%)
         occurrences all number
    2
    10
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Ankle fracture
         subjects affected / exposed
    5 / 2368 (0.21%)
    2 / 2368 (0.08%)
         occurrences all number
    5
    2
    Arthropod bite
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Arthropod sting
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Bone contusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Bone fissure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Chest injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Chillblains
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Clavicle fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Compression fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    10 / 2368 (0.42%)
    9 / 2368 (0.38%)
         occurrences all number
    10
    10
    Craniocerebral injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Face injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Facial bones fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Fall
         subjects affected / exposed
    5 / 2368 (0.21%)
    2 / 2368 (0.08%)
         occurrences all number
    5
    3
    Fibula fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    4 / 2368 (0.17%)
         occurrences all number
    0
    4
    Foot fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Forearm fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Frostbite
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hand fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Head injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Heat illness
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Joint dislocation
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Joint injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Ligament injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    4
    2
    Lower limb fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Limb injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Lumbar vertebral fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Mouth injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Meniscus injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Muscle rupture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Muscle strain
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Osteochondral fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Patella fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Post procedural haematoma
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Post-traumatic neck syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Postoperative delirium
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Pseudophakic bullous keratopathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Radius fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Reactive gastropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Rib fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    8 / 2368 (0.34%)
         occurrences all number
    2
    8
    Road traffic accident
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Scratch
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Skin abrasion
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    4
    3
    Skin injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    5 / 2368 (0.21%)
    2 / 2368 (0.08%)
         occurrences all number
    6
    2
    Skull fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Spinal column injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Spinal compression fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Spinal cord injury cervical
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Subcutaneous haematoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Tendon injury
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Tooth fracture
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Tooth injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Toxicity to various agents
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Upper limb fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Wound
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    1
    5
    Wound complication
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Wound haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Wrist fracture
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    58 / 2368 (2.45%)
    52 / 2368 (2.20%)
         occurrences all number
    63
    55
    Cardiac failure
         subjects affected / exposed
    76 / 2368 (3.21%)
    130 / 2368 (5.49%)
         occurrences all number
    90
    154
    Acute coronary syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Angina pectoris
         subjects affected / exposed
    8 / 2368 (0.34%)
    17 / 2368 (0.72%)
         occurrences all number
    10
    22
    Angina unstable
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Arrhythmia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Atrial flutter
         subjects affected / exposed
    10 / 2368 (0.42%)
    9 / 2368 (0.38%)
         occurrences all number
    10
    9
    Atrial tachycardia
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences all number
    6
    6
    Atrial thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Atrioventricular block
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Atrioventricular block complete
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Bradyarrhythmia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Bradycardia
         subjects affected / exposed
    3 / 2368 (0.13%)
    7 / 2368 (0.30%)
         occurrences all number
    3
    7
    Bundle branch block left
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Bundle branch block right
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cardiac aneurysm
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cardiac asthma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cardiac failure acute
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences all number
    2
    5
    Cardiac failure chronic
         subjects affected / exposed
    4 / 2368 (0.17%)
    10 / 2368 (0.42%)
         occurrences all number
    5
    12
    Cardiac failure congestive
         subjects affected / exposed
    15 / 2368 (0.63%)
    12 / 2368 (0.51%)
         occurrences all number
    16
    14
    Cardiac ventricular thrombosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cardiomegaly
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cardiomyopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Chronotropic incompetence
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Coronary artery disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    5 / 2368 (0.21%)
         occurrences all number
    0
    5
    Coronary artery stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Extrasystoles
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Intracardiac thrombus
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Left ventricular failure
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Left ventricular hypertrophy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Mitral valve disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Mitral valve incompetence
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Myocardial infarction
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Myocardial ischaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Palpitations
         subjects affected / exposed
    4 / 2368 (0.17%)
    8 / 2368 (0.34%)
         occurrences all number
    4
    10
    Pericardial effusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Sinus arrest
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Sinus bradycardia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Sinus node dysfunction
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Sinus tachycardia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Tachycardia
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences all number
    3
    3
    Tachycardia paroxysmal
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Tricuspid valve incompetence
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Ventricular arrhythmia
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Ventricular extrasystoles
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences all number
    3
    4
    Ventricular fibrillation
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Ventricular tachyarrhythmia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ventricular tachycardia
         subjects affected / exposed
    12 / 2368 (0.51%)
    18 / 2368 (0.76%)
         occurrences all number
    19
    22
    Nervous system disorders
    Ageusia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Aphasia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ataxia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Autonomic neuropathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Balance disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Brain oedema
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Carotid artery disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Carotid artery stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Cerebral atrophy
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Cerebrovascular accident
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cerebrovascular disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cognitive disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dementia
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    3
    2
    Dementia Alzheimer's type
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Diabetic neuropathy
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Diplegia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Disturbance in attention
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dizziness
         subjects affected / exposed
    44 / 2368 (1.86%)
    26 / 2368 (1.10%)
         occurrences all number
    49
    28
    Dizziness postural
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Dysdiadochokinesis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dysgeusia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Facial paralysis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Headache
         subjects affected / exposed
    10 / 2368 (0.42%)
    8 / 2368 (0.34%)
         occurrences all number
    10
    8
    Hypoaesthesia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Hypotonia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ischaemic stroke
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Lacunar infarction
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Leukoencephalopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Memory impairment
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Migraine
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Myoclonus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Nystagmus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Paraesthesia
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Peripheral nerve paresis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Peroneal nerve palsy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Post herpetic neuralgia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Presyncope
         subjects affected / exposed
    5 / 2368 (0.21%)
    1 / 2368 (0.04%)
         occurrences all number
    6
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Radiculopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Reduced facial expression
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Retrograde amnesia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences all number
    2
    6
    Somnolence
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Syncope
         subjects affected / exposed
    6 / 2368 (0.25%)
    9 / 2368 (0.38%)
         occurrences all number
    6
    10
    Taste disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Transient ischaemic attack
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Tremor
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Uraemic encephalopathy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Visual field defect
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Abdominal lymphadenopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    10 / 2368 (0.42%)
    13 / 2368 (0.55%)
         occurrences all number
    10
    13
    Blood loss anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Hypochromic anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 2368 (0.17%)
    10 / 2368 (0.42%)
         occurrences all number
    4
    10
    Leukocytosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Microcytic anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Nephrogenic anaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    3 / 2368 (0.13%)
         occurrences all number
    3
    3
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Normocytic anaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Polycythaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Splenomegaly
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Deafness neurosensory
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ear canal stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ear discomfort
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ear haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Eustachian tube dysfunction
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Hypoacusis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Tinnitus
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Vertigo
         subjects affected / exposed
    3 / 2368 (0.13%)
    7 / 2368 (0.30%)
         occurrences all number
    3
    7
    Vertigo positional
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Blepharitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cataract
         subjects affected / exposed
    6 / 2368 (0.25%)
    14 / 2368 (0.59%)
         occurrences all number
    7
    15
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    3
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Cornea verticillata
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Dry eye
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Eye haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Eyelid bleeding
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Glaucoma
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Hypermetropia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Macular fibrosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Photopsia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Retinal artery occlusion
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Retinal detachment
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Retinal vascular thrombosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Retinal vein occlusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Retinopathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Scintillating scotoma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Ulcerative keratitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Vision blurred
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Visual impairment
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Vitreous adhesions
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Vitreous degeneration
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    7 / 2368 (0.30%)
    3 / 2368 (0.13%)
         occurrences all number
    7
    3
    Abdominal distension
         subjects affected / exposed
    1 / 2368 (0.04%)
    5 / 2368 (0.21%)
         occurrences all number
    1
    5
    Abdominal hernia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Abdominal pain
         subjects affected / exposed
    6 / 2368 (0.25%)
    9 / 2368 (0.38%)
         occurrences all number
    6
    9
    Abdominal pain lower
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Abdominal pain upper
         subjects affected / exposed
    7 / 2368 (0.30%)
    4 / 2368 (0.17%)
         occurrences all number
    7
    4
    Anal fissure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Anal fistula
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Anal pruritus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Aptyalism
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ascites
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Chronic gastritis
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    2
    3
    Coeliac artery stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Colitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Colitis ulcerative
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Constipation
         subjects affected / exposed
    8 / 2368 (0.34%)
    27 / 2368 (1.14%)
         occurrences all number
    8
    28
    Defaecation urgency
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Dental caries
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    3
    2
    Diarrhoea
         subjects affected / exposed
    25 / 2368 (1.06%)
    32 / 2368 (1.35%)
         occurrences all number
    27
    32
    Diverticulum
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Diverticulum intestinal
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Dry mouth
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Duodenal ulcer
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Dysphagia
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Enteritis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Enterocolitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Erosive oesophagitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Faeces discoloured
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Faeces hard
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Flatulence
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Food poisoning
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastric disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Gastric polyps
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastric ulcer
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Gastritis
         subjects affected / exposed
    6 / 2368 (0.25%)
    5 / 2368 (0.21%)
         occurrences all number
    7
    5
    Gastritis erosive
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Gingival pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Gingival swelling
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Glossitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Haemorrhoids
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Hiatus hernia
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Ileus paralytic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    4 / 2368 (0.17%)
    2 / 2368 (0.08%)
         occurrences all number
    4
    2
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Large intestinal stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Lip swelling
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Nausea
         subjects affected / exposed
    9 / 2368 (0.38%)
    8 / 2368 (0.34%)
         occurrences all number
    9
    9
    Oesophagitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Pancreatic disorder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Periodontal disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Peritoneal haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Rectal haemorrhage
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Toothache
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences all number
    4
    4
    Umbilical hernia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Varices oesophageal
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    6 / 2368 (0.25%)
    5 / 2368 (0.21%)
         occurrences all number
    6
    5
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Cholelithiasis
         subjects affected / exposed
    5 / 2368 (0.21%)
    3 / 2368 (0.13%)
         occurrences all number
    5
    3
    Cryptogenic cirrhosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Hepatic congestion
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Hepatic cyst
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Hepatic failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    2
    Hepatic function abnormal
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    2
    3
    Hepatic steatosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Hepatitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hepatorenal failure
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Liver disorder
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    2
    Liver injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Portal hypertension
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Alopecia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Asteatosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Blister
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Decubitus ulcer
         subjects affected / exposed
    0 / 2368 (0.00%)
    4 / 2368 (0.17%)
         occurrences all number
    0
    4
    Dermatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dermatitis allergic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dermatitis contact
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    3
    2
    Dermatitis exfoliative generalised
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Diabetic foot
         subjects affected / exposed
    6 / 2368 (0.25%)
    1 / 2368 (0.04%)
         occurrences all number
    6
    1
    Drug eruption
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dry skin
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ecchymosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Eczema
         subjects affected / exposed
    9 / 2368 (0.38%)
    4 / 2368 (0.17%)
         occurrences all number
    10
    4
    Eczema asteatotic
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    3
    Erythema
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Erythema multiforme
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Haemorrhage subcutaneous
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    2
    3
    Henoch-Schonlein purpura
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Lichen sclerosus
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Lichenoid keratosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Onychomadesis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Peau d'orange
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Petechiae
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Photosensitivity reaction
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Pruritus
         subjects affected / exposed
    9 / 2368 (0.38%)
    9 / 2368 (0.38%)
         occurrences all number
    10
    10
    Pruritus generalised
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Rash
         subjects affected / exposed
    14 / 2368 (0.59%)
    11 / 2368 (0.46%)
         occurrences all number
    14
    12
    Rash erythematous
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Rash generalised
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Rash pruritic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Sebaceous hyperplasia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Skin erosion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Skin irritation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Skin mass
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Skin ulcer
         subjects affected / exposed
    5 / 2368 (0.21%)
    8 / 2368 (0.34%)
         occurrences all number
    6
    8
    Urticaria
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    2
    3
    Swelling face
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    63 / 2368 (2.66%)
    56 / 2368 (2.36%)
         occurrences all number
    67
    60
    Acute kidney injury
         subjects affected / exposed
    26 / 2368 (1.10%)
    26 / 2368 (1.10%)
         occurrences all number
    28
    29
    Azotaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Calculus urinary
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Chronic kidney disease
         subjects affected / exposed
    15 / 2368 (0.63%)
    18 / 2368 (0.76%)
         occurrences all number
    15
    23
    Cystitis haemorrhagic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Diabetic nephropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Dysuria
         subjects affected / exposed
    6 / 2368 (0.25%)
    4 / 2368 (0.17%)
         occurrences all number
    6
    4
    Glycosuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    5 / 2368 (0.21%)
    10 / 2368 (0.42%)
         occurrences all number
    5
    11
    Hypertonic bladder
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Incontinence
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Microalbuminuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Micturition disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Micturition urgency
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    4 / 2368 (0.17%)
    2 / 2368 (0.08%)
         occurrences all number
    4
    2
    Nephropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Nephropathy toxic
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Nocturia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Pollakiuria
         subjects affected / exposed
    6 / 2368 (0.25%)
    3 / 2368 (0.13%)
         occurrences all number
    6
    3
    Polyuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Prerenal failure
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Renal atrophy
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Renal cyst
         subjects affected / exposed
    3 / 2368 (0.13%)
    2 / 2368 (0.08%)
         occurrences all number
    3
    2
    Renal disorder
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Renal failure
         subjects affected / exposed
    37 / 2368 (1.56%)
    32 / 2368 (1.35%)
         occurrences all number
    39
    37
    Renal injury
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Renal mass
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Tubulointerstitial nephritis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Urethral atrophy
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Urethral caruncle
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Urethral obstruction
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Urethritis noninfective
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Urinary incontinence
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Urinary retention
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences all number
    3
    4
    Urinary tract inflammation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Diabetes insipidus
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hyperthyroidism
         subjects affected / exposed
    5 / 2368 (0.21%)
    5 / 2368 (0.21%)
         occurrences all number
    5
    5
    Hypoparathyroidism
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hypothyroidism
         subjects affected / exposed
    9 / 2368 (0.38%)
    7 / 2368 (0.30%)
         occurrences all number
    9
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    8 / 2368 (0.34%)
    12 / 2368 (0.51%)
         occurrences all number
    8
    16
    Arthritis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Arthropathy
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Back pain
         subjects affected / exposed
    19 / 2368 (0.80%)
    27 / 2368 (1.14%)
         occurrences all number
    19
    29
    Bursitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Bone pain
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Chondrocalcinosis pyrophosphate
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Dupuytren's contracture
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Costochondritis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Exostosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Foot deformity
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Flank pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Gouty arthritis
         subjects affected / exposed
    3 / 2368 (0.13%)
    4 / 2368 (0.17%)
         occurrences all number
    3
    4
    Groin pain
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Joint swelling
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Lumbar spinal stenosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Muscle spasms
         subjects affected / exposed
    6 / 2368 (0.25%)
    4 / 2368 (0.17%)
         occurrences all number
    6
    4
    Muscle tightness
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Muscular weakness
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Musculoskeletal chest pain
         subjects affected / exposed
    7 / 2368 (0.30%)
    3 / 2368 (0.13%)
         occurrences all number
    8
    5
    Musculoskeletal pain
         subjects affected / exposed
    6 / 2368 (0.25%)
    3 / 2368 (0.13%)
         occurrences all number
    6
    3
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Myalgia
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences all number
    2
    4
    Neck pain
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences all number
    5
    3
    Osteitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Osteoarthritis
         subjects affected / exposed
    10 / 2368 (0.42%)
    2 / 2368 (0.08%)
         occurrences all number
    10
    2
    Osteochondrosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Osteopenia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Osteoporosis
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    3
    0
    Osteosclerosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    12 / 2368 (0.51%)
    15 / 2368 (0.63%)
         occurrences all number
    12
    16
    Pain in jaw
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Periarthritis
         subjects affected / exposed
    2 / 2368 (0.08%)
    3 / 2368 (0.13%)
         occurrences all number
    2
    3
    Periostitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pseudarthrosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Scleroderma
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Scoliosis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Spinal deformity
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Spinal osteoarthritis
         subjects affected / exposed
    4 / 2368 (0.17%)
    1 / 2368 (0.04%)
         occurrences all number
    4
    1
    Spinal pain
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Spinal stenosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Trigger finger
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Vertebral osteophyte
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    63 / 2368 (2.66%)
    76 / 2368 (3.21%)
         occurrences all number
    84
    100
    Abdominal sepsis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Acarodermatitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Acute sinusitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Appendicitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Arthritis infective
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Atypical pneumonia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Bacteraemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Bacterial infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    3 / 2368 (0.13%)
         occurrences all number
    0
    3
    Balanitis candida
         subjects affected / exposed
    3 / 2368 (0.13%)
    0 / 2368 (0.00%)
         occurrences all number
    7
    0
    Body tinea
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    22 / 2368 (0.93%)
    23 / 2368 (0.97%)
         occurrences all number
    23
    24
    Bronchitis bacterial
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Bronchitis viral
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Candida infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Cellulitis
         subjects affected / exposed
    9 / 2368 (0.38%)
    14 / 2368 (0.59%)
         occurrences all number
    11
    14
    Chronic sinusitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Clostridium difficile infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Cystitis
         subjects affected / exposed
    6 / 2368 (0.25%)
    12 / 2368 (0.51%)
         occurrences all number
    7
    13
    Dacryocystitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dengue fever
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Dermatitis infected
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Empyema
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Epiglottitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Erysipelas
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences all number
    3
    6
    Eye infection bacterial
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Fungal balanitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Fungal infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Furuncle
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastroenteritis
         subjects affected / exposed
    5 / 2368 (0.21%)
    12 / 2368 (0.51%)
         occurrences all number
    5
    12
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Genital infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Genital infection fungal
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Gingivitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Groin infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Helicobacter infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Hepatitis B
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hepatitis C
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Herpes zoster
         subjects affected / exposed
    2 / 2368 (0.08%)
    6 / 2368 (0.25%)
         occurrences all number
    2
    7
    Hordeolum
         subjects affected / exposed
    1 / 2368 (0.04%)
    3 / 2368 (0.13%)
         occurrences all number
    1
    3
    Infected bite
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Infected dermal cyst
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Infected skin ulcer
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    22 / 2368 (0.93%)
    18 / 2368 (0.76%)
         occurrences all number
    23
    20
    Klebsiella infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Labyrinthitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Localised infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    4 / 2368 (0.17%)
         occurrences all number
    2
    4
    Lung abscess
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Lung infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Lyme disease
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Nail bed infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Omphalitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Onychomycosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Ophthalmic herpes zoster
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Orchitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Oral candidiasis
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Osteomyelitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Otitis externa
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Otitis media
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Otitis media chronic
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Paronychia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    2
    Pathogen resistance
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Penile infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Periodontitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    4 / 2368 (0.17%)
         occurrences all number
    2
    4
    Peritonitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Pharyngitis
         subjects affected / exposed
    3 / 2368 (0.13%)
    6 / 2368 (0.25%)
         occurrences all number
    3
    6
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Pneumonia
         subjects affected / exposed
    28 / 2368 (1.18%)
    30 / 2368 (1.27%)
         occurrences all number
    28
    32
    Post procedural infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Pulpitis dental
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Pyelonephritis chronic
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Pyelonephritis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Respiratory tract infection
         subjects affected / exposed
    7 / 2368 (0.30%)
    3 / 2368 (0.13%)
         occurrences all number
    7
    3
    Respiratory tract infection viral
         subjects affected / exposed
    7 / 2368 (0.30%)
    6 / 2368 (0.25%)
         occurrences all number
    10
    10
    Rhinitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Septic embolus
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Septic shock
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Sialoadenitis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Skin infection
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    2
    0
    Tinea pedis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Tonsillitis
         subjects affected / exposed
    2 / 2368 (0.08%)
    1 / 2368 (0.04%)
         occurrences all number
    2
    1
    Tooth infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Tracheitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Tracheobronchitis
         subjects affected / exposed
    4 / 2368 (0.17%)
    2 / 2368 (0.08%)
         occurrences all number
    4
    2
    Upper respiratory tract infection
         subjects affected / exposed
    15 / 2368 (0.63%)
    15 / 2368 (0.63%)
         occurrences all number
    15
    16
    Urinary tract infection
         subjects affected / exposed
    34 / 2368 (1.44%)
    31 / 2368 (1.31%)
         occurrences all number
    40
    40
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Urosepsis
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Viral infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Viral pharyngitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Viral sinusitis
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Vulvovaginal mycotic infection
         subjects affected / exposed
    2 / 2368 (0.08%)
    0 / 2368 (0.00%)
         occurrences all number
    6
    0
    Wound infection
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    5 / 2368 (0.21%)
    7 / 2368 (0.30%)
         occurrences all number
    6
    7
    Dehydration
         subjects affected / exposed
    25 / 2368 (1.06%)
    21 / 2368 (0.89%)
         occurrences all number
    25
    23
    Diabetes mellitus
         subjects affected / exposed
    23 / 2368 (0.97%)
    40 / 2368 (1.69%)
         occurrences all number
    23
    40
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Diabetic metabolic decompensation
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Dyslipidaemia
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Electrolyte imbalance
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Fluid overload
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Fluid retention
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Folate deficiency
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Glucose tolerance impaired
         subjects affected / exposed
    3 / 2368 (0.13%)
    1 / 2368 (0.04%)
         occurrences all number
    3
    1
    Gout
         subjects affected / exposed
    15 / 2368 (0.63%)
    18 / 2368 (0.76%)
         occurrences all number
    16
    21
    Hypercalcaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    2 / 2368 (0.08%)
         occurrences all number
    1
    2
    Hypercholesterolaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
         subjects affected / exposed
    8 / 2368 (0.34%)
    5 / 2368 (0.21%)
         occurrences all number
    8
    5
    Hyperkalaemia
         subjects affected / exposed
    30 / 2368 (1.27%)
    35 / 2368 (1.48%)
         occurrences all number
    34
    39
    Hypernatraemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    5 / 2368 (0.21%)
         occurrences all number
    1
    5
    Hyperphosphataemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Hyperuricaemia
         subjects affected / exposed
    8 / 2368 (0.34%)
    18 / 2368 (0.76%)
         occurrences all number
    8
    19
    Hypervolaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hypocalcaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    13 / 2368 (0.55%)
    24 / 2368 (1.01%)
         occurrences all number
    17
    27
    Hypokalaemia
         subjects affected / exposed
    16 / 2368 (0.68%)
    19 / 2368 (0.80%)
         occurrences all number
    18
    23
    Hypomagnesaemia
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Hyponatraemia
         subjects affected / exposed
    4 / 2368 (0.17%)
    3 / 2368 (0.13%)
         occurrences all number
    4
    3
    Hypophosphataemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Hypovolaemia
         subjects affected / exposed
    32 / 2368 (1.35%)
    21 / 2368 (0.89%)
         occurrences all number
    34
    22
    Iron deficiency
         subjects affected / exposed
    0 / 2368 (0.00%)
    2 / 2368 (0.08%)
         occurrences all number
    0
    2
    Magnesium deficiency
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Metabolic acidosis
         subjects affected / exposed
    1 / 2368 (0.04%)
    1 / 2368 (0.04%)
         occurrences all number
    1
    1
    Polydipsia
         subjects affected / exposed
    0 / 2368 (0.00%)
    1 / 2368 (0.04%)
         occurrences all number
    0
    1
    Postprandial hypoglycaemia
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0
    Type 2 diabetes mellitus
         subjects affected / exposed
    36 / 2368 (1.52%)
    48 / 2368 (2.03%)
         occurrences all number
    36
    48
    Vitamin D deficiency
         subjects affected / exposed
    2 / 2368 (0.08%)
    2 / 2368 (0.08%)
         occurrences all number
    2
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    1 / 2368 (0.04%)
    0 / 2368 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Oct 2017
    Amendment #2 included expanding the adverse event of interest category of amputations to also include: AEs leading to a risk for lower limb amputations (“preceding events”). This AE of interest was added based on discussion with regulatory authorities.

    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
    For support, Contact us.
    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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