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    Clinical Trial Results:
    Non-vitamin K antagonist Oral anticoagulants in patients with Atrial High rate episodes

    Summary
    EudraCT number
    		 2015-003997-33
    Trial protocol
    		 BE   DE   GB   ES   AT   NL   BG   SE   PL   CZ   HU   PT   GR   DK   IT   RO  
    Global end of trial date
    31 Dec 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2024
    First version publication date
    28 Apr 2024
    Other versions
    Summary report(s)
    		 Clinical Study Report NOAH - AFNET 6

    Trial information

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    Trial identification
    Sponsor protocol code
    NOAH-AFNET6
    Additional study identifiers
    ISRCTN number
    		 ISRCTN17309850
    US NCT number
    		 NCT02618577
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork]
    Sponsor organisation address
    Mendelstraße 11, Münster, Germany, 48149
    Public contact
    Clinical Trials Information AFNET, Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork], +49 2519801340, info@kompetenznetz-vorhofflimmern.de
    Scientific contact
    Clinical Trials Information AFNET, Kompetenznetz Vorhofflimmern e.V. (AFNET) [Atrial Fibrillation NETwork], +49 2519801340, info@kompetenznetz-vorhofflimmern.de
    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
    20 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Aug 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardio-vascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with AHRE but without overt AF and at least two stroke risk factors leading to a modified CHA2DS2VASc score of 2 or more.
    Protection of trial subjects
    A Data and Safety Monitoring Board (DSMB) was established to ensure independent monitoring of patient safety. All data obtained in the context of the clinical trial are subject to data protection. The patients will be advised in the informed consent forms that they have the right to withdraw from study participation at any time without statement of reasons.
    Background therapy
    		 -
    Evidence for comparator
    		 ASA has been used for decades as standard therapeutic agent for antithrombotic therapy according to corresponding medical guidelines. Within NOAH - AFNET 6 either tablets of 100 mg ASA will be applied or matching placebo tablets.
    Actual start date of recruitment
    15 Mar 2016
    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
    Ukraine: 354
    Country: Number of subjects enrolled
    Poland: 277
    Country: Number of subjects enrolled
    Netherlands: 49
    Country: Number of subjects enrolled
    Portugal: 25
    Country: Number of subjects enrolled
    Romania: 14
    Country: Number of subjects enrolled
    Spain: 370
    Country: Number of subjects enrolled
    Sweden: 16
    Country: Number of subjects enrolled
    United Kingdom: 167
    Country: Number of subjects enrolled
    Austria: 238
    Country: Number of subjects enrolled
    Belgium: 28
    Country: Number of subjects enrolled
    Bulgaria: 22
    Country: Number of subjects enrolled
    Czechia: 12
    Country: Number of subjects enrolled
    Denmark: 18
    Country: Number of subjects enrolled
    France: 97
    Country: Number of subjects enrolled
    Germany: 727
    Country: Number of subjects enrolled
    Greece: 8
    Country: Number of subjects enrolled
    Hungary: 70
    Country: Number of subjects enrolled
    Italy: 169
    Worldwide total number of subjects
    2661
    EEA total number of subjects
    2140
    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)
    1
    From 65 to 84 years
    2243
    85 years and over
    417

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited by contracted study sites only with adequate experience in follow-up of implanted pacemakers, defibrillators or insertable cardiac monitors in clinical routine and in treatment of patients with AF.

    Pre-assignment
    Screening details
    		 Adult patients aged ≥65 with atrial high rate episodes (duration at least 6 min and frequency at least 170 bpm), detected by implantable devices and a CHA2DS2VASc score of 2 or more.

    Pre-assignment period milestones
    Number of subjects started
    		 2661
    Number of subjects completed

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 "NOAC” group
    Arm description
    		 In the “NOAC” group one edoxaban tablet plus one placebo tablet matching in colour, weight, form and size to ASA 100 mg will be administered per day irrespective of stratum according to indication for use of antiplatelet therapy. The use of edoxaban eliminates the necessity of parallel intake of ASA 100 mg in case of an indication for use of antiplatelet therapy.
    Arm type
    		 Experimental

    Investigational medicinal product name
    edoxaban
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the “NOAC” group one edoxaban tablet plus one placebo tablet matching in colour, weight, form and size to ASA 100 mg will be administered per day irrespective of stratum according to indication for use of antiplatelet therapy. The use of edoxaban eliminates the necessity of parallel intake of ASA 100 mg in case of an indication for use of antiplatelet therapy. Edoxaban will be used in NOAH - AFNET 6 at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics: - Impaired renal function (CrCl 15-50 ml/min), or - low body weight (≤60 kg), or - patients receiving the p-glycoprotein inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole.

    Arm title
    		 “Usual Care” group
    Arm description
    		 In the “Usual Care” group either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be adminis-tered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator.
    Arm type
    		 Active comparator or placebo

    Investigational medicinal product name
    ASA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the “Usual Care” group either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be administered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator.

    Number of subjects in period 1 [1]
    		"NOAC” group “Usual Care” group
    Started
    1306
    1302
    Completed
    1270
    1264
    Not completed
    36
    38
         Consent withdrawn by subject
    24
    32
         other reasons
    4
    1
         No adequate AHRE
    5
    3
         Documented atrial fibrillation after randomization
    3
    2
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The modified intention to treat population (mITT) consists of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug. The mITT doesn't include patients that were randomized but a) have AF onset before 1st dose of Investigational medicinal product (IMP), or b) die before 1st dose of IMP, c) withdrew their consent before 1st dose of IMP or d) are lost to follow-up before 1st dose of the IMP.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    "NOAC” group
    Reporting group description
    		 In the “NOAC” group one edoxaban tablet plus one placebo tablet matching in colour, weight, form and size to ASA 100 mg will be administered per day irrespective of stratum according to indication for use of antiplatelet therapy. The use of edoxaban eliminates the necessity of parallel intake of ASA 100 mg in case of an indication for use of antiplatelet therapy.

    Reporting group title
    “Usual Care” group
    Reporting group description
    		 In the “Usual Care” group either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be adminis-tered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator.

    Reporting group values
    		 "NOAC” group “Usual Care” group Total
    Number of subjects
    		 1306 1302 2608
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 77.47 ± 6.57 77.59 ± 6.79 -
    Gender categorical
    Units: Subjects
        Female
    		 483 495 978
        Male
    		 823 807 1630
    Subject analysis sets

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The primary analysis is in the modified intention-to-treat population, consisting of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug.

    Subject analysis sets values
    		 mITT
    Number of subjects
    2534
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    77.46 ± 6.65
    Gender categorical
    Units: Subjects
        Female
    947
        Male
    1587

    End points

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    End points reporting groups
    Reporting group title
    "NOAC” group
    Reporting group description
    		 In the “NOAC” group one edoxaban tablet plus one placebo tablet matching in colour, weight, form and size to ASA 100 mg will be administered per day irrespective of stratum according to indication for use of antiplatelet therapy. The use of edoxaban eliminates the necessity of parallel intake of ASA 100 mg in case of an indication for use of antiplatelet therapy.

    Reporting group title
    “Usual Care” group
    Reporting group description
    		 In the “Usual Care” group either one tablet of ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg or one placebo tablet matching in colour, weight, form and size to ASA 100 mg plus one placebo tablet matching in colour, form and size to edoxaban 60 mg will be adminis-tered per day depending on the indication for use of antiplatelet therapy as assessed by the responsible investigator.

    Subject analysis set title
    mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The primary analysis is in the modified intention-to-treat population, consisting of all randomised patients with a qualifying AHRE and intake of at least one dose of study drug.

    Primary: First Primary Outcome

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    End point title
    		 First Primary Outcome
    End point description
    The primary endpoint is the time from randomisation to the first occurrence of stroke, systemic embolism or cardiovascular death.
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 "NOAC” group “Usual Care” group
    Number of subjects analysed
    1270
    1264
    Units: Events
        first occurrence of stroke
    22
    27
        systemic embolism
    14
    28
        cardiovascular death
    52
    57
        Composite
    83
    101
    Statistical analysis title
    		 Time-to-event analysis
    Statistical analysis description
    A cause-specific Cox proportional hazards model is used, along with the Breslow method to handle tied time points for events, with a frailty term for the trial site, the trial-group assignment as a predictor variable, and the randomization strata indication for acetylsalicylic acid as a covariate.
    Comparison groups
    "NOAC” group v “Usual Care” group
    Number of subjects included in analysis
    2534
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1476
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.08

    Secondary: Composite safety endpoint

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    End point title
    		 Composite safety endpoint
    End point description
    The safety endpoint is the time from randomisation to the first occurrence of major bleeding or all-cause death.
    End point type
    Secondary
    End point timeframe
    Overall trial
    End point values
    		 "NOAC” group “Usual Care” group
    Number of subjects analysed
    1270
    1264
    Units: Events
        major bleeding
    53
    25
        all-cause death
    111
    94
        Composite
    149
    114
    Statistical analysis title
    		 Time-to-event analysis
    Statistical analysis description
    A cause-specific Cox proportional hazards model is used, along with the Breslow method to handle tied time points for events, with a frailty term for the trial site, the trial-group assignment as a predictor variable, and the randomization strata indication for acetylsalicylic acid as a covariate.
    Comparison groups
    "NOAC” group v “Usual Care” group
    Number of subjects included in analysis
    2534
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0325
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.67

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Edoxaban
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Edoxaban Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    498 / 1306 (38.13%)
    467 / 1302 (35.87%)
         number of deaths (all causes)
    142
    125
         number of deaths resulting from adverse events
    142
    125
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
    Additional description: Abdominal neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Additional description: Acute myeloid leukaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
    Additional description: Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
    Additional description: Adenocarcinoma gastric
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
    Additional description: Benign neoplasm of bladder
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer
    Additional description: Bladder cancer
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Bladder transitional cell carcinoma recurrent
    Additional description: Bladder transitional cell carcinoma recurrent
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
    Additional description: Bowen's disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone cancer metastatic
    Additional description: Bone cancer metastatic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
    Additional description: Bronchial carcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carcinoma in situ of skin
    Additional description: Carcinoma in situ of skin
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
    Additional description: Cholangiocarcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Additional description: Chronic lymphocytic leukaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Colorectal adenoma
    Additional description: Colorectal adenoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
    Additional description: Colon neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    10 / 1306 (0.77%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Endometrial cancer
    Additional description: Endometrial cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gammopathy
    Additional description: Gammopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
    Additional description: Gastric cancer
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric neoplasm
    Additional description: Gastric neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal carcinoma
    Additional description: Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypergammaglobulinaemia benign monoclonal
    Additional description: Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
    Additional description: Laryngeal cancer
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lipoma
    Additional description: Lipoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
    Additional description: Lung cancer metastatic
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung neoplasm malignant
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    8 / 1306 (0.61%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 9
         deaths causally related to treatment / all
    1 / 5
    0 / 3
    Lymphoma
    Additional description: Lymphoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
    Additional description: Meningioma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to bone
    Additional description: Metastases to bone
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma malignant
    Additional description: Mesothelioma malignant
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
    Additional description: Metastases to central nervous system
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
    Additional description: Metastases to liver
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metastases to lung
    Additional description: Metastases to lung
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lymph nodes
    Additional description: Metastases to lymph nodes
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to pleura
    Additional description: Metastases to pleura
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to the mediastinum
    Additional description: Metastases to the mediastinum
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
    Additional description: Metastasis
         subjects affected / exposed
    7 / 1306 (0.54%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Metastases to pancreas
    Additional description: Metastases to pancreas
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
    Additional description: Myelodysplastic syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Myelofibrosis
    Additional description: Myelofibrosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neoplasm malignant
    Additional description: Neoplasm malignant
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Nasal sinus cancer
    Additional description: Nasal sinus cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
    Additional description: Neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's lymphoma
    Additional description: Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal adenocarcinoma
    Additional description: Oesophageal adenocarcinoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal carcinoma
    Additional description: Oesophageal carcinoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian adenoma
    Additional description: Ovarian adenoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
    Additional description: Ovarian cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic neoplasm
    Additional description: Pancreatic neoplasm
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
    Additional description: Pancreatic carcinoma
         subjects affected / exposed
    5 / 1306 (0.38%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Pancreatic carcinoma metastatic
    Additional description: Pancreatic carcinoma metastatic
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
    Additional description: Plasma cell myeloma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal cancer
    Additional description: Pharyngeal cancer
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma
    Additional description: Pleural mesothelioma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma malignant
    Additional description: Pleural mesothelioma malignant
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    9 / 1306 (0.69%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
    Additional description: Prostate cancer metastatic
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
    Additional description: Rectal cancer
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
    Additional description: Rectal neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid cancer
    Additional description: Rectosigmoid cancer
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer
    Additional description: Renal cancer
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer stage IV
    Additional description: Renal cancer stage IV
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal neoplasm
    Additional description: Renal neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland cancer
    Additional description: Salivary gland cancer
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland neoplasm
    Additional description: Salivary gland neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of head and neck
    Additional description: Squamous cell carcinoma of head and neck
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
    Additional description: Squamous cell carcinoma of lung
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
    Additional description: Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the oral cavity
    Additional description: Squamous cell carcinoma of the oral cavity
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
    Additional description: Tonsil cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue neoplasm malignant stage unspecified
    Additional description: Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
    Additional description: Transitional cell carcinoma
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tumour haemorrhage
    Additional description: Tumour haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal cancer
    Additional description: Vaginal cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Angiodysplasia
    Additional description: Angiodysplasia
         subjects affected / exposed
    5 / 1306 (0.38%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial haemorrhage
    Additional description: Arterial haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bleeding varicose vein
    Additional description: Bleeding varicose vein
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
    Additional description: Embolism arterial
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giant cell arteritis
    Additional description: Giant cell arteritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    18 / 1306 (1.38%)
    10 / 1302 (0.77%)
         occurrences causally related to treatment / all
    6 / 20
    3 / 10
         deaths causally related to treatment / all
    1 / 4
    0 / 2
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
    Additional description: Hypertensive emergency
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
    Additional description: Lymphoedema
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
    Additional description: Peripheral artery stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
    Additional description: Peripheral artery occlusion
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    7 / 1306 (0.54%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Peripheral embolism
    Additional description: Peripheral embolism
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
    Additional description: Peripheral ischaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Superficial vein thrombosis
    Additional description: Superficial vein thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
    Additional description: Venous thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous stenosis
    Additional description: Venous stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
    Additional description: Vasculitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominal cavity drainage
    Additional description: Abdominal cavity drainage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess drainage
    Additional description: Abscess drainage
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal wall operation
    Additional description: Abdominal wall operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amputation
    Additional description: Amputation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm repair
    Additional description: Aneurysm repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal lesion excision
    Additional description: Anal lesion excision
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm repair
    Additional description: Aortic aneurysm repair
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
    Additional description: Angioplasty
         subjects affected / exposed
    5 / 1306 (0.38%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve replacement
    Additional description: Aortic valve replacement
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic stent insertion
    Additional description: Aortic stent insertion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic bypass
    Additional description: Aortic bypass
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial aneurysm repair
    Additional description: Arterial aneurysm repair
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
    Additional description: Appendicectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stent insertion
    Additional description: Arterial stent insertion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
    Additional description: Arteriovenous fistula operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrodesis
    Additional description: Arthrodesis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial appendage closure
    Additional description: Atrial appendage closure
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stent insertion
    Additional description: Bile duct stent insertion
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stent removal
    Additional description: Bile duct stent removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary catheter insertion
    Additional description: Biliary catheter insertion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder catheter removal
    Additional description: Bladder catheter removal
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder catheter temporary
    Additional description: Bladder catheter temporary
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder catheterisation
    Additional description: Bladder catheterisation
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm surgery
    Additional description: Bladder neoplasm surgery
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder polypectomy
    Additional description: Bladder polypectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachytherapy
    Additional description: Brachytherapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast conserving surgery
    Additional description: Breast conserving surgery
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast prosthesis removal
    Additional description: Breast prosthesis removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bunion operation
    Additional description: Bunion operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursa removal
    Additional description: Bursa removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer surgery
    Additional description: Cancer surgery
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
    Additional description: Cardiac ablation
         subjects affected / exposed
    15 / 1306 (1.15%)
    15 / 1302 (1.15%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker adjustment
    Additional description: Cardiac pacemaker adjustment
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
    Additional description: Cardiac pacemaker insertion
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker removal
    Additional description: Cardiac pacemaker removal
         subjects affected / exposed
    2 / 1306 (0.15%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker replacement
    Additional description: Cardiac pacemaker replacement
         subjects affected / exposed
    38 / 1306 (2.91%)
    57 / 1302 (4.38%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 58
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac resynchronisation therapy
    Additional description: Cardiac resynchronisation therapy
         subjects affected / exposed
    19 / 1306 (1.45%)
    13 / 1302 (1.00%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
    Additional description: Cardioversion
         subjects affected / exposed
    21 / 1306 (1.61%)
    21 / 1302 (1.61%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
    Additional description: Carotid endarterectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central venous catheter removal
    Additional description: Central venous catheter removal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central venous catheterisation
    Additional description: Central venous catheterisation
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemotherapy
    Additional description: Chemotherapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    11 / 1306 (0.84%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithotomy
    Additional description: Cholelithotomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circumcision
    Additional description: Circumcision
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colectomy
    Additional description: Colectomy
         subjects affected / exposed
    8 / 1306 (0.61%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Colostomy
    Additional description: Colostomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery bypass
    Additional description: Coronary artery bypass
         subjects affected / exposed
    5 / 1306 (0.38%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coronary arterial stent insertion
    Additional description: Coronary arterial stent insertion
         subjects affected / exposed
    29 / 1306 (2.22%)
    27 / 1302 (2.07%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
    Additional description: Coronary angioplasty
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst drainage
    Additional description: Cyst drainage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corpora cavernosa surgery
    Additional description: Corpora cavernosa surgery
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniectomy
    Additional description: Craniectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Debridement
    Additional description: Debridement
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytoreductive surgery
    Additional description: Cytoreductive surgery
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal sphincterotomy
    Additional description: Duodenal sphincterotomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenectomy
    Additional description: Duodenectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear tube insertion
    Additional description: Ear tube insertion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocoagulation
    Additional description: Electrocoagulation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endarterectomy
    Additional description: Endarterectomy
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eventration repair
    Additional description: Eventration repair
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid operation
    Additional description: Eyelid operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot amputation
    Additional description: Foot amputation
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrectomy
    Additional description: Gastrectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal endoscopic therapy
    Additional description: Gastrointestinal endoscopic therapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glossectomy
    Additional description: Glossectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrostomy
    Additional description: Gastrostomy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma evacuation
    Additional description: Haematoma evacuation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodialysis
    Additional description: Haemodialysis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoid operation
    Additional description: Haemorrhoid operation
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
    Additional description: Hip arthroplasty
         subjects affected / exposed
    16 / 1306 (1.23%)
    11 / 1302 (0.84%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip surgery
    Additional description: Hip surgery
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hospitalisation
    Additional description: Hospitalisation
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    High frequency ablation
    Additional description: High frequency ablation
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileostomy
    Additional description: Ileostomy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immunochemotherapy
    Additional description: Immunochemotherapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia repair
    Additional description: Inguinal hernia repair
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infiltration anaesthesia
    Additional description: Infiltration anaesthesia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Internal fixation of fracture
    Additional description: Internal fixation of fracture
         subjects affected / exposed
    9 / 1306 (0.69%)
    9 / 1302 (0.69%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal operation
    Additional description: Intestinal operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular lens implant
    Additional description: Intraocular lens implant
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-aortic balloon placement
    Additional description: Intra-aortic balloon placement
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Knee arthroplasty
    Additional description: Knee arthroplasty
         subjects affected / exposed
    6 / 1306 (0.46%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint fluid drainage
    Additional description: Joint fluid drainage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jejunectomy
    Additional description: Jejunectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laparotomy
    Additional description: Laparotomy
         subjects affected / exposed
    5 / 1306 (0.38%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Laparoscopic surgery
    Additional description: Laparoscopic surgery
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
    Additional description: Knee operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal polypectomy
    Additional description: Large intestinal polypectomy
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal prosthesis placement
    Additional description: Laryngeal prosthesis placement
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal operation
    Additional description: Laryngeal operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngectomy
    Additional description: Laryngectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lesion excision
    Additional description: Lesion excision
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lithotripsy
    Additional description: Lithotripsy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver ablation
    Additional description: Liver ablation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb amputation
    Additional description: Limb amputation
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Liver operation
    Additional description: Liver operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung lobectomy
    Additional description: Lung lobectomy
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mammoplasty
    Additional description: Mammoplasty
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device implantation
    Additional description: Medical device implantation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenectomy
    Additional description: Lymphadenectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma surgery
    Additional description: Meningioma surgery
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve repair
    Additional description: Mitral valve repair
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck dissection
    Additional description: Neck dissection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy
    Additional description: Nephrectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrostomy
    Additional description: Nephrostomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal prosthesis insertion
    Additional description: Oesophageal prosthesis insertion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal dilation procedure
    Additional description: Oesophageal dilation procedure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopaedic procedure
    Additional description: Orthopaedic procedure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreaticoduodenectomy
    Additional description: Pancreaticoduodenectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
    Additional description: Parathyroidectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paracentesis
    Additional description: Paracentesis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotidectomy
    Additional description: Parotidectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial drainage
    Additional description: Pericardial drainage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic operation
    Additional description: Pelvic operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
    Additional description: Percutaneous coronary intervention
         subjects affected / exposed
    28 / 1306 (2.14%)
    36 / 1302 (2.76%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 39
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral artery angioplasty
    Additional description: Peripheral artery angioplasty
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
    Additional description: Peripheral artery bypass
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stent insertion
    Additional description: Peripheral artery stent insertion
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve destruction
    Additional description: Peripheral nerve destruction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal fistula repair
    Additional description: Pharyngeal fistula repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal operation
    Additional description: Pharyngeal operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurectomy
    Additional description: Pleurectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polypectomy
    Additional description: Polypectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Positive airway pressure therapy
    Additional description: Positive airway pressure therapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctectomy
    Additional description: Proctectomy
         subjects affected / exposed
    5 / 1306 (0.38%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatectomy
    Additional description: Prostatectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ptosis repair
    Additional description: Ptosis repair
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiotherapy
    Additional description: Radiotherapy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiotherapy to lung
    Additional description: Radiotherapy to lung
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiotherapy to rectum
    Additional description: Radiotherapy to rectum
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse repair
    Additional description: Rectal prolapse repair
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of internal fixation
    Additional description: Removal of internal fixation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal stone removal
    Additional description: Renal stone removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Resuscitation
    Additional description: Resuscitation
         subjects affected / exposed
    1 / 1306 (0.08%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Shoulder operation
    Additional description: Shoulder operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin neoplasm excision
    Additional description: Skin neoplasm excision
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal resection
    Additional description: Small intestinal resection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal laminectomy
    Additional description: Spinal laminectomy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal operation
    Additional description: Spinal operation
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal decompression
    Additional description: Spinal decompression
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery
    Additional description: Surgery
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Therapeutic procedure
    Additional description: Therapeutic procedure
         subjects affected / exposed
    16 / 1306 (1.23%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    10 / 22
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Thoracic cavity drainage
    Additional description: Thoracic cavity drainage
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombectomy
    Additional description: Thrombectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombolysis
    Additional description: Thrombolysis
         subjects affected / exposed
    0 / 1306 (0.00%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thyroidectomy
    Additional description: Thyroidectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation
    Additional description: Toe amputation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transcatheter aortic valve implantation
    Additional description: Transcatheter aortic valve implantation
         subjects affected / exposed
    6 / 1306 (0.46%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
    Additional description: Tracheostomy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transfusion
    Additional description: Transfusion
         subjects affected / exposed
    58 / 1306 (4.44%)
    28 / 1302 (2.15%)
         occurrences causally related to treatment / all
    23 / 78
    3 / 37
         deaths causally related to treatment / all
    1 / 8
    0 / 4
    Transurethral prostatectomy
    Additional description: Transurethral prostatectomy
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour excision
    Additional description: Tumour excision
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral bladder resection
    Additional description: Transurethral bladder resection
         subjects affected / exposed
    9 / 1306 (0.69%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    1 / 11
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia repair
    Additional description: Umbilical hernia repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral stent insertion
    Additional description: Ureteral stent insertion
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral stent removal
    Additional description: Ureteral stent removal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethrotomy
    Additional description: Urethrotomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary cystectomy
    Additional description: Urinary cystectomy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence surgery
    Additional description: Urinary incontinence surgery
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse repair
    Additional description: Uterine prolapse repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular operation
    Additional description: Vascular operation
         subjects affected / exposed
    2 / 1306 (0.15%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vaginal prolapse repair
    Additional description: Vaginal prolapse repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein operation
    Additional description: Varicose vein operation
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitrectomy
    Additional description: Vitrectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord operation
    Additional description: Vocal cord operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Adverse drug reaction
    Additional description: Adverse drug reaction
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Cardiac death
    Additional description: Cardiac death
         subjects affected / exposed
    21 / 1306 (1.61%)
    22 / 1302 (1.69%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 22
         deaths causally related to treatment / all
    0 / 21
    0 / 21
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    5 / 1306 (0.38%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    Additional description: Death
         subjects affected / exposed
    103 / 1306 (7.89%)
    87 / 1302 (6.68%)
         occurrences causally related to treatment / all
    4 / 103
    0 / 88
         deaths causally related to treatment / all
    4 / 102
    0 / 87
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multimorbidity
    Additional description: Multimorbidity
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Multiple organ dysfunction syndrome
    Additional description: Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    6 / 1306 (0.46%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker generated arrhythmia
    Additional description: Pacemaker generated arrhythmia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site haemorrhage
    Additional description: Puncture site haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    5 / 1306 (0.38%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
    Additional description: Sudden cardiac death
         subjects affected / exposed
    18 / 1306 (1.38%)
    15 / 1302 (1.15%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 15
         deaths causally related to treatment / all
    0 / 18
    0 / 15
    Systemic inflammatory response syndrome
    Additional description: Systemic inflammatory response syndrome
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Ulcer
    Additional description: Ulcer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital lesion
    Additional description: Genital lesion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
    Additional description: Uterine prolapse
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal prolapse
    Additional description: Vaginal prolapse
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory distress syndrome
    Additional description: Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
    Additional description: Aspiration
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    8 / 1306 (0.61%)
    8 / 1302 (0.61%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cystic lung disease
    Additional description: Cystic lung disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
    Additional description: Cough
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    8 / 1306 (0.61%)
    8 / 1302 (0.61%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
    Additional description: Emphysema
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    1 / 5
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
    Additional description: Haemothorax
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
    Additional description: Interstitial lung disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nasal septum deviation
    Additional description: Nasal septum deviation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive sleep apnoea syndrome
    Additional description: Obstructive sleep apnoea syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    8 / 1306 (0.61%)
    8 / 1302 (0.61%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pneumonitis
    Additional description: Pneumonitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    3 / 1306 (0.23%)
    10 / 1302 (0.77%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary fibrosis
    Additional description: Pulmonary fibrosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary hypertension
    Additional description: Pulmonary hypertension
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
    Additional description: Pulmonary mass
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory acidosis
    Additional description: Respiratory acidosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    11 / 1306 (0.84%)
    7 / 1302 (0.54%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
         deaths causally related to treatment / all
    1 / 6
    0 / 2
    Restrictive pulmonary disease
    Additional description: Restrictive pulmonary disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic haemorrhage
    Additional description: Thoracic haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Aggression
    Additional description: Aggression
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agitation
    Additional description: Agitation
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic idiopathic pain syndrome
    Additional description: Chronic idiopathic pain syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
    Additional description: Completed suicide
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    Additional description: Depression
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in social behaviour
    Additional description: Disturbance in social behaviour
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
    Additional description: Disorientation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
    Additional description: Drug abuse
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Drug dependence
    Additional description: Drug dependence
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder
    Additional description: Mental disorder
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
    Additional description: Suicide attempt
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device lead issue
    Additional description: Device lead issue
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device inappropriate shock delivery
    Additional description: Device inappropriate shock delivery
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
    Additional description: Device dislocation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
    Additional description: Device malfunction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
    Additional description: Device occlusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
    Additional description: Lead dislodgement
         subjects affected / exposed
    1 / 1306 (0.08%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Undersensing
    Additional description: Undersensing
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile duct stone
    Additional description: Bile duct stone
         subjects affected / exposed
    6 / 1306 (0.46%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary tract disorder
    Additional description: Biliary tract disorder
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    5 / 1306 (0.38%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    8 / 1306 (0.61%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholangitis
    Additional description: Cholangitis
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholestasis
    Additional description: Cholestasis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic lesion
    Additional description: Hepatic lesion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
    Additional description: Hepatic cyst
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
    Additional description: Jaundice cholestatic
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
    Additional description: Jaundice
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liver disorder
    Additional description: Liver disorder
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post cholecystectomy syndrome
    Additional description: Post cholecystectomy syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiocardiogram
    Additional description: Angiocardiogram
         subjects affected / exposed
    20 / 1306 (1.53%)
    26 / 1302 (2.00%)
         occurrences causally related to treatment / all
    1 / 22
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram
    Additional description: Angiogram
         subjects affected / exposed
    1 / 1306 (0.08%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriogram carotid
    Additional description: Arteriogram carotid
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration joint
    Additional description: Aspiration joint
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration pleural cavity
    Additional description: Aspiration pleural cavity
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy
    Additional description: Biopsy
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy adrenal gland
    Additional description: Biopsy adrenal gland
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy bladder
    Additional description: Biopsy bladder
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy heart
    Additional description: Biopsy heart
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy lymph gland
    Additional description: Biopsy lymph gland
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy lung
    Additional description: Biopsy lung
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy kidney
    Additional description: Biopsy kidney
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy pericardium
    Additional description: Biopsy pericardium
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy skin
    Additional description: Biopsy skin
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
    Additional description: Biopsy prostate
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Capsule endoscopy
    Additional description: Capsule endoscopy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac electrophysiologic study
    Additional description: Cardiac electrophysiologic study
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker evaluation
    Additional description: Cardiac pacemaker evaluation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation cardiac
    Additional description: Catheterisation cardiac
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    37 / 1306 (2.83%)
    20 / 1302 (1.54%)
         occurrences causally related to treatment / all
    19 / 45
    6 / 21
         deaths causally related to treatment / all
    1 / 1
    0 / 1
    Coronavirus test positive
    Additional description: Coronavirus test positive
         subjects affected / exposed
    34 / 1306 (2.60%)
    36 / 1302 (2.76%)
         occurrences causally related to treatment / all
    1 / 41
    0 / 37
         deaths causally related to treatment / all
    1 / 16
    0 / 17
    Cystoscopy
    Additional description: Cystoscopy
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diagnostic procedure
    Additional description: Diagnostic procedure
         subjects affected / exposed
    40 / 1306 (3.06%)
    16 / 1302 (1.23%)
         occurrences causally related to treatment / all
    16 / 48
    4 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Electrocardiogram ambulatory
    Additional description: Electrocardiogram ambulatory
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopic retrograde cholangiopancreatography
    Additional description: Endoscopic retrograde cholangiopancreatography
         subjects affected / exposed
    14 / 1306 (1.07%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Endoscopy small intestine
    Additional description: Endoscopy small intestine
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endoscopy upper gastrointestinal tract
    Additional description: Endoscopy upper gastrointestinal tract
         subjects affected / exposed
    54 / 1306 (4.13%)
    23 / 1302 (1.77%)
         occurrences causally related to treatment / all
    24 / 64
    4 / 27
         deaths causally related to treatment / all
    1 / 3
    0 / 1
    Human rhinovirus test positive
    Additional description: Human rhinovirus test positive
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinoscopy
    Additional description: Mediastinoscopy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal manometry
    Additional description: Oesophageal manometry
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagogastroduodenoscopy
    Additional description: Oesophagogastroduodenoscopy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal biopsy
    Additional description: Paranasal biopsy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumovirus test positive
    Additional description: Pneumovirus test positive
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep study
    Additional description: Sleep study
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteroscopy abnormal
    Additional description: Ureteroscopy abnormal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venogram
    Additional description: Venogram
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral test negative
    Additional description: Viral test negative
         subjects affected / exposed
    95 / 1306 (7.27%)
    93 / 1302 (7.14%)
         occurrences causally related to treatment / all
    7 / 130
    2 / 122
         deaths causally related to treatment / all
    0 / 3
    0 / 8
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accident at home
    Additional description: Accident at home
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acetabulum fracture
    Additional description: Acetabulum fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula aneurysm
    Additional description: Arteriovenous fistula aneurysm
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
    Additional description: Arterial injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
    Additional description: Cardiac procedure complication
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervical vertebral fracture
    Additional description: Cervical vertebral fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
    Additional description: Concussion
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
    Additional description: Compression fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
    Additional description: Complications of transplanted kidney
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial fracture
    Additional description: Craniofacial fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
    Additional description: Craniocerebral injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fall
    Additional description: Fall
         subjects affected / exposed
    16 / 1306 (1.23%)
    20 / 1302 (1.54%)
         occurrences causally related to treatment / all
    2 / 17
    2 / 23
         deaths causally related to treatment / all
    1 / 2
    0 / 1
    Femoral neck fracture
    Additional description: Femoral neck fracture
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    Additional description: Femur fracture
         subjects affected / exposed
    9 / 1306 (0.69%)
    10 / 1302 (0.77%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Fibula fracture
    Additional description: Fibula fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
    Additional description: Forearm fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured sacrum
    Additional description: Fractured sacrum
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
    Additional description: Head injury
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
    Additional description: Hip fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
    Additional description: Humerus fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immunisation reaction
    Additional description: Immunisation reaction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
    Additional description: Injury
         subjects affected / exposed
    3 / 1306 (0.23%)
    7 / 1302 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intentional overdose
    Additional description: Intentional overdose
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
    Additional description: Jaw fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    Additional description: Joint dislocation
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
    Additional description: Joint injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip injury
    Additional description: Lip injury
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple fractures
    Additional description: Multiple fractures
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Multiple injuries
    Additional description: Multiple injuries
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasal injury
    Additional description: Nasal injury
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoradionecrosis
    Additional description: Osteoradionecrosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
    Additional description: Pelvic fracture
         subjects affected / exposed
    3 / 1306 (0.23%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Patella fracture
    Additional description: Patella fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haematoma
    Additional description: Periorbital haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
    Additional description: Post procedural haematoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
    Additional description: Procedural haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    Additional description: Radius fracture
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reactive gastropathy
    Additional description: Reactive gastropathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Scrotal haematoma
    Additional description: Scrotal haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
    Additional description: Skull fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
    Additional description: Spinal column injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural haematoma
    Additional description: Subdural haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Stoma complication
    Additional description: Stoma complication
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
    Additional description: Sternal fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
    Additional description: Subdural haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
    Additional description: Toxicity to various agents
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
    Additional description: Traumatic haematoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
    Additional description: Vascular pseudoaneurysm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Haemophilia
    Additional description: Haemophilia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
    Additional description: Phimosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    3 / 1306 (0.23%)
    9 / 1302 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    14 / 1306 (1.07%)
    19 / 1302 (1.46%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    14 / 1306 (1.07%)
    11 / 1302 (0.84%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
    Additional description: Angina unstable
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
    Additional description: Aortic valve stenosis
         subjects affected / exposed
    4 / 1306 (0.31%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    38 / 1306 (2.91%)
    39 / 1302 (3.00%)
         occurrences causally related to treatment / all
    0 / 50
    0 / 51
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    6 / 1306 (0.46%)
    11 / 1302 (0.84%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
    Additional description: Atrial thrombosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
    Additional description: Bundle branch block left
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    93 / 1306 (7.12%)
    90 / 1302 (6.91%)
         occurrences causally related to treatment / all
    1 / 145
    0 / 131
         deaths causally related to treatment / all
    0 / 22
    0 / 19
    Cardiac failure acute
    Additional description: Cardiac failure acute
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac amyloidosis
    Additional description: Cardiac amyloidosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
    Additional description: Cardiogenic shock
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
    Additional description: Cardiomyopathy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    6 / 1306 (0.46%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 6
    0 / 6
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    7 / 1306 (0.54%)
    8 / 1302 (0.61%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dilated cardiomyopathy
    Additional description: Dilated cardiomyopathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
    Additional description: Extrasystoles
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
    Additional description: Ischaemic cardiomyopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
    Additional description: Intracardiac thrombus
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
    Additional description: Mitral valve incompetence
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve stenosis
    Additional description: Mitral valve stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
    Additional description: Myocardial infarction
         subjects affected / exposed
    5 / 1306 (0.38%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
    Additional description: Pericarditis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
    Additional description: Tachyarrhythmia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve incompetence
    Additional description: Tricuspid valve incompetence
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
    Additional description: Ventricular arrhythmia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    5 / 1306 (0.38%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
    Additional description: Amnesia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery aneurysm
    Additional description: Carotid artery aneurysm
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda equina syndrome
    Additional description: Cauda equina syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar haemorrhage
    Additional description: Cerebellar haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haematoma
    Additional description: Cerebral haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cerebral small vessel ischaemic disease
    Additional description: Cerebral small vessel ischaemic disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
    Additional description: Cerebral haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    2 / 2
    1 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cerebrovascular accident
    Additional description: Cerebrovascular accident
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervicobrachial syndrome
    Additional description: Cervicobrachial syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
    Additional description: Cognitive disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's type
    Additional description: Dementia Alzheimer's type
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dementia
    Additional description: Dementia
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
    Additional description: Diabetic neuropathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in attention
    Additional description: Disturbance in attention
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
    Additional description: Embolic stroke
         subjects affected / exposed
    7 / 1306 (0.54%)
    9 / 1302 (0.69%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Epilepsy
    Additional description: Epilepsy
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
    Additional description: Guillain-Barre syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
    Additional description: Haemorrhage intracranial
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
    Additional description: Haemorrhagic stroke
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic transformation stroke
    Additional description: Haemorrhagic transformation stroke
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    Additional description: Headache
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    25 / 1306 (1.91%)
    29 / 1302 (2.23%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 30
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Lacunar stroke
    Additional description: Lacunar stroke
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
    Additional description: Metabolic encephalopathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nystagmus
    Additional description: Nystagmus
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Additional description: Nervous system disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
    Additional description: Paraplegia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's disease
    Additional description: Parkinson's disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Parkinsonism
    Additional description: Parkinsonism
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restless legs syndrome
    Additional description: Restless legs syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
    Additional description: Speech disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
    Additional description: Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 2
    3 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    9 / 1306 (0.69%)
    9 / 1302 (0.69%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
    Additional description: Transient global amnesia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    6 / 1306 (0.46%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    44 / 1306 (3.37%)
    16 / 1302 (1.23%)
         occurrences causally related to treatment / all
    20 / 55
    3 / 26
         deaths causally related to treatment / all
    1 / 2
    0 / 2
    Anaemia vitamin B12 deficiency
    Additional description: Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
    Additional description: Lymphadenopathy mediastinal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paratracheal lymphadenopathy
    Additional description: Paratracheal lymphadenopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Ear haemorrhage
    Additional description: Ear haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
    Additional description: Sudden hearing loss
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    4 / 1306 (0.31%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
    Additional description: Amaurosis fugax
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Additional description: Retinal artery occlusion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    3 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein thrombosis
    Additional description: Retinal vein thrombosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual field defect
    Additional description: Visual field defect
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreoretinal traction syndrome
    Additional description: Vitreoretinal traction syndrome
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal incarcerated hernia
    Additional description: Abdominal incarcerated hernia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's oesophagus
    Additional description: Barrett's oesophagus
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
    Additional description: Colitis ischaemic
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    9 / 1306 (0.69%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
    Additional description: Diverticulum
         subjects affected / exposed
    4 / 1306 (0.31%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    3 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
    Additional description: Duodenitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
    Additional description: Duodenal ulcer haemorrhage
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
    Additional description: Enteritis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
    Additional description: Faecaloma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
    Additional description: Gastritis haemorrhagic
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
    Additional description: Gastritis erosive
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric ulcer
    Additional description: Gastric ulcer
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal perforation
    Additional description: Gastrointestinal perforation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal necrosis
    Additional description: Gastrointestinal necrosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal obstruction
    Additional description: Gastrointestinal obstruction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    50 / 1306 (3.83%)
    19 / 1302 (1.46%)
         occurrences causally related to treatment / all
    34 / 66
    3 / 23
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Gastrointestinal ulcer haemorrhage
    Additional description: Gastrointestinal ulcer haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal vascular malformation haemorrhagic
    Additional description: Gastrointestinal vascular malformation haemorrhagic
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
    Additional description: Haematemesis
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    6 / 1306 (0.46%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    4 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
    Additional description: Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
    Additional description: Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
    Additional description: Hiatus hernia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    Additional description: Ileus
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 1306 (0.00%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
    Additional description: Intestinal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Intestinal perforation
    Additional description: Intestinal perforation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal polyp
    Additional description: Intestinal polyp
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
    Additional description: Intra-abdominal haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
    Additional description: Large intestine polyp
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
    Additional description: Large intestine perforation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    4 / 1306 (0.31%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery embolism
    Additional description: Mesenteric artery embolism
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal haemorrhage
    Additional description: Oesophageal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal mucosa erythema
    Additional description: Oesophageal mucosa erythema
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
    Additional description: Oesophageal stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
    Additional description: Oesophageal ulcer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis acute
    Additional description: Pancreatitis acute
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
    Additional description: Proctitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis haemorrhagic
    Additional description: Proctitis haemorrhagic
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse
    Additional description: Rectal prolapse
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    3 / 4
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
    Additional description: Retroperitoneal haematoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
    Additional description: Umbilical hernia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
    Additional description: Upper gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
    Additional description: Varices oesophageal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus of small bowel
    Additional description: Volvulus of small bowel
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
    Additional description: Diabetic foot
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage subcutaneous
    Additional description: Haemorrhage subcutaneous
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
    Additional description: Rash
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    14 / 1306 (1.07%)
    13 / 1302 (1.00%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Bladder disorder
    Additional description: Bladder disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
    Additional description: Calculus urinary
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    6 / 1302 (0.46%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    9 / 1306 (0.69%)
    8 / 1302 (0.61%)
         occurrences causally related to treatment / all
    2 / 13
    5 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hydronephrosis
    Additional description: Hydronephrosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy toxic
    Additional description: Nephropathy toxic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal failure
    Additional description: Prerenal failure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal pelvis fistula
    Additional description: Renal pelvis fistula
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    6 / 1306 (0.46%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Ureteric stenosis
    Additional description: Ureteric stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
    Additional description: Ureterolithiasis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
    Additional description: Urethral haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
    Additional description: Urinary bladder haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism
    Additional description: Hyperparathyroidism
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
    Additional description: Cervical spinal stenosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
    Additional description: Haemarthrosis
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma muscle
    Additional description: Haematoma muscle
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
    Additional description: Intervertebral disc degeneration
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint effusion
    Additional description: Joint effusion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
    Additional description: Lumbar spinal stenosis
         subjects affected / exposed
    6 / 1306 (0.46%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    8 / 1306 (0.61%)
    10 / 1302 (0.77%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
    Additional description: Pseudarthrosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
    Additional description: Rhabdomyolysis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
    Additional description: Rheumatoid arthritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sacroiliitis
    Additional description: Sacroiliitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal infection
    Additional description: Abdominal infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
    Additional description: Appendicitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
    Additional description: Arthritis infective
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
    Additional description: Bacteraemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary sepsis
    Additional description: Biliary sepsis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain abscess
    Additional description: Brain abscess
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
    Additional description: Bronchitis viral
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
    Additional description: Clostridium difficile infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (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
    Additional description: Clostridium difficile colitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Clostridium colitis
    Additional description: Clostridium colitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
    Additional description: Coronavirus infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    6 / 1306 (0.46%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    1 / 6
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysematous pyelonephritis
    Additional description: Emphysematous pyelonephritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
    Additional description: Empyema
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
    Additional description: Endocarditis
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Enterococcal sepsis
    Additional description: Enterococcal sepsis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer helicobacter
    Additional description: Gastric ulcer helicobacter
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    Additional description: Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Groin abscess
    Additional description: Groin abscess
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst infection
    Additional description: Hepatic cyst infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
    Additional description: Hepatitis E
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    4 / 1306 (0.31%)
    7 / 1302 (0.54%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant site infection
    Additional description: Implant site infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral discitis
    Additional description: Intervertebral discitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    4 / 1306 (0.31%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinal abscess
    Additional description: Mediastinal abscess
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myelitis
    Additional description: Myelitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    Additional description: Osteomyelitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
    Additional description: Otitis media chronic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic abscess
    Additional description: Pancreatic abscess
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papilloma viral infection
    Additional description: Papilloma viral infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
    Additional description: Pneumonia pneumococcal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    58 / 1306 (4.44%)
    56 / 1302 (4.30%)
         occurrences causally related to treatment / all
    1 / 74
    1 / 61
         deaths causally related to treatment / all
    1 / 22
    0 / 16
    Post procedural infection
    Additional description: Post procedural infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
    Additional description: Postoperative wound infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    6 / 1306 (0.46%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
    Additional description: Rhinovirus infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
    Additional description: Sepsis
         subjects affected / exposed
    3 / 1306 (0.23%)
    9 / 1302 (0.69%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Septic shock
    Additional description: Septic shock
         subjects affected / exposed
    9 / 1306 (0.69%)
    5 / 1302 (0.38%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 7
    0 / 3
    Streptococcal endocarditis
    Additional description: Streptococcal endocarditis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous abscess
    Additional description: Subcutaneous abscess
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection
    Additional description: Superinfection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection bacterial
    Additional description: Superinfection bacterial
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    23 / 1306 (1.76%)
    19 / 1302 (1.46%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 21
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    3 / 1306 (0.23%)
    7 / 1302 (0.54%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis
    Additional description: Acidosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    6 / 1306 (0.46%)
    7 / 1302 (0.54%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetic ketoacidosis
    Additional description: Diabetic ketoacidosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus inadequate control
    Additional description: Diabetes mellitus inadequate control
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Electrolyte imbalance
    Additional description: Electrolyte imbalance
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
    Additional description: Gout
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    4 / 1302 (0.31%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic hyperosmolar nonketotic syndrome
    Additional description: Hyperglycaemic hyperosmolar nonketotic syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
    Additional description: Metabolic acidosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Edoxaban Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    562 / 1306 (43.03%)
    534 / 1302 (41.01%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
    Additional description: Adenocarcinoma of colon
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    3
    Bladder cancer
    Additional description: Bladder cancer
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Carcinoma in situ of skin
    Additional description: Carcinoma in situ of skin
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Colon cancer
    Additional description: Colon cancer
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Colorectal cancer recurrent
    Additional description: Colorectal cancer recurrent
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hypergammaglobulinaemia benign monoclonal
    Additional description: Hypergammaglobulinaemia benign monoclonal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Laryngeal cancer
    Additional description: Laryngeal cancer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Malignant melanoma in situ
    Additional description: Malignant melanoma in situ
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lung neoplasm malignant
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    2
    Lymphoma
    Additional description: Lymphoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Metastases to kidney
    Additional description: Metastases to kidney
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Metastases to liver
    Additional description: Metastases to liver
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Metastases to lung
    Additional description: Metastases to lung
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Myeloproliferative neoplasm
    Additional description: Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Neoplasm
    Additional description: Neoplasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Plasmacytoma
    Additional description: Plasmacytoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Plasma cell myeloma
    Additional description: Plasma cell myeloma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    7 / 1306 (0.54%)
    5 / 1302 (0.38%)
         occurrences all number
    7
    5
    Prostate cancer metastatic
    Additional description: Prostate cancer metastatic
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Skin cancer
    Additional description: Skin cancer
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    3
    Squamous cell carcinoma
    Additional description: Squamous cell carcinoma
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Squamous cell carcinoma of skin
    Additional description: Squamous cell carcinoma of skin
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Vascular disorders
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    2
    Angiodysplasia
    Additional description: Angiodysplasia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Aortic arteriosclerosis
    Additional description: Aortic arteriosclerosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Aortic dilatation
    Additional description: Aortic dilatation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Aortic thrombosis
    Additional description: Aortic thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Arteriosclerosis
    Additional description: Arteriosclerosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Bleeding varicose vein
    Additional description: Bleeding varicose vein
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Blood pressure fluctuation
    Additional description: Blood pressure fluctuation
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    21 / 1306 (1.61%)
    17 / 1302 (1.31%)
         occurrences all number
    24
    17
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences all number
    6
    2
    Hot flush
    Additional description: Hot flush
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    8 / 1306 (0.61%)
    10 / 1302 (0.77%)
         occurrences all number
    8
    11
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    4 / 1306 (0.31%)
    4 / 1302 (0.31%)
         occurrences all number
    4
    4
    Hypertensive emergency
    Additional description: Hypertensive emergency
         subjects affected / exposed
    0 / 1306 (0.00%)
    3 / 1302 (0.23%)
         occurrences all number
    0
    3
    Hypertensive urgency
    Additional description: Hypertensive urgency
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    13 / 1306 (1.00%)
    11 / 1302 (0.84%)
         occurrences all number
    14
    12
    Intermittent claudication
    Additional description: Intermittent claudication
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Orthostatic hypotension
    Additional description: Orthostatic hypotension
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Peripheral artery occlusion
    Additional description: Peripheral artery occlusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Peripheral venous disease
    Additional description: Peripheral venous disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Phlebitis
    Additional description: Phlebitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Raynaud's phenomenon
    Additional description: Raynaud's phenomenon
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Superficial vein thrombosis
    Additional description: Superficial vein thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Subgaleal haematoma
    Additional description: Subgaleal haematoma
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Thrombosis
    Additional description: Thrombosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Varicose ulceration
    Additional description: Varicose ulceration
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Varicose vein
    Additional description: Varicose vein
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Venous thrombosis
    Additional description: Venous thrombosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Surgical and medical procedures
    Arthrodesis
    Additional description: Arthrodesis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Bladder neoplasm surgery
    Additional description: Bladder neoplasm surgery
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Blepharoplasty
    Additional description: Blepharoplasty
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Bunion operation
    Additional description: Bunion operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Cancer surgery
    Additional description: Cancer surgery
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Cardioversion
    Additional description: Cardioversion
         subjects affected / exposed
    6 / 1306 (0.46%)
    9 / 1302 (0.69%)
         occurrences all number
    7
    11
    Cardiac resynchronisation therapy
    Additional description: Cardiac resynchronisation therapy
         subjects affected / exposed
    6 / 1306 (0.46%)
    3 / 1302 (0.23%)
         occurrences all number
    6
    3
    Cardiac pacemaker replacement
    Additional description: Cardiac pacemaker replacement
         subjects affected / exposed
    36 / 1306 (2.76%)
    39 / 1302 (3.00%)
         occurrences all number
    36
    40
    Cardiac pacemaker removal
    Additional description: Cardiac pacemaker removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Cardiac pacemaker insertion
    Additional description: Cardiac pacemaker insertion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Carpal tunnel decompression
    Additional description: Carpal tunnel decompression
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences all number
    3
    3
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    11 / 1306 (0.84%)
    12 / 1302 (0.92%)
         occurrences all number
    15
    15
    Catheter management
    Additional description: Catheter management
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    3
    Cholelithotomy
    Additional description: Cholelithotomy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Coronary arterial stent insertion
    Additional description: Coronary arterial stent insertion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Dental implantation
    Additional description: Dental implantation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Endodontic procedure
    Additional description: Endodontic procedure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Electrocauterisation
    Additional description: Electrocauterisation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eye operation
    Additional description: Eye operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eyelid operation
    Additional description: Eyelid operation
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    4
    0
    Finger amputation
    Additional description: Finger amputation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Gastric polypectomy
    Additional description: Gastric polypectomy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Haematoma evacuation
    Additional description: Haematoma evacuation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hydrocele operation
    Additional description: Hydrocele operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Internal fixation of fracture
    Additional description: Internal fixation of fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Inguinal hernia repair
    Additional description: Inguinal hernia repair
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Jaw operation
    Additional description: Jaw operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Large intestinal polypectomy
    Additional description: Large intestinal polypectomy
         subjects affected / exposed
    5 / 1306 (0.38%)
    0 / 1302 (0.00%)
         occurrences all number
    5
    0
    Knee operation
    Additional description: Knee operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    3
    Knee arthroplasty
    Additional description: Knee arthroplasty
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Liver operation
    Additional description: Liver operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Medical device removal
    Additional description: Medical device removal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Mole excision
    Additional description: Mole excision
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Papilloma excision
    Additional description: Papilloma excision
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Peripheral artery angioplasty
    Additional description: Peripheral artery angioplasty
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Percutaneous coronary intervention
    Additional description: Percutaneous coronary intervention
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Prostatic operation
    Additional description: Prostatic operation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Radiotherapy to prostate
    Additional description: Radiotherapy to prostate
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Rhizolysis
    Additional description: Rhizolysis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Sclerotherapy
    Additional description: Sclerotherapy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Rhinoplasty
    Additional description: Rhinoplasty
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Shoulder operation
    Additional description: Shoulder operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Skin operation
    Additional description: Skin operation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Skin lesion removal
    Additional description: Skin lesion removal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Skin neoplasm excision
    Additional description: Skin neoplasm excision
         subjects affected / exposed
    8 / 1306 (0.61%)
    5 / 1302 (0.38%)
         occurrences all number
    10
    6
    Toe amputation
    Additional description: Toe amputation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    11 / 1306 (0.84%)
    4 / 1302 (0.31%)
         occurrences all number
    12
    4
    Transurethral bladder resection
    Additional description: Transurethral bladder resection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Adverse drug reaction
    Additional description: Adverse drug reaction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    18 / 1306 (1.38%)
    15 / 1302 (1.15%)
         occurrences all number
    20
    17
    Chest discomfort
    Additional description: Chest discomfort
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    20 / 1306 (1.53%)
    19 / 1302 (1.46%)
         occurrences all number
    21
    20
    Complication associated with device
    Additional description: Complication associated with device
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Facial pain
    Additional description: Facial pain
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Fatigue
    Additional description: Fatigue
         subjects affected / exposed
    8 / 1306 (0.61%)
    11 / 1302 (0.84%)
         occurrences all number
    8
    11
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    2
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    2 / 1306 (0.15%)
    4 / 1302 (0.31%)
         occurrences all number
    2
    4
    Infusion site extravasation
    Additional description: Infusion site extravasation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Inflammation
    Additional description: Inflammation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Illness
    Additional description: Illness
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Malaise
    Additional description: Malaise
         subjects affected / exposed
    10 / 1306 (0.77%)
    4 / 1302 (0.31%)
         occurrences all number
    10
    4
    Non-cardiac chest pain
    Additional description: Non-cardiac chest pain
         subjects affected / exposed
    7 / 1306 (0.54%)
    7 / 1302 (0.54%)
         occurrences all number
    13
    7
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    16 / 1306 (1.23%)
    19 / 1302 (1.46%)
         occurrences all number
    20
    19
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    6 / 1306 (0.46%)
    3 / 1302 (0.23%)
         occurrences all number
    6
    3
    Pain
    Additional description: Pain
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Peripheral swelling
    Additional description: Peripheral swelling
         subjects affected / exposed
    7 / 1306 (0.54%)
    7 / 1302 (0.54%)
         occurrences all number
    7
    7
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    4 / 1306 (0.31%)
    5 / 1302 (0.38%)
         occurrences all number
    4
    5
    Swelling face
    Additional description: Swelling face
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ulcer
    Additional description: Ulcer
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Vaccination site haematoma
    Additional description: Vaccination site haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Social circumstances
    Breast prosthesis user
    Additional description: Breast prosthesis user
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Living in residential institution
    Additional description: Living in residential institution
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
    Additional description: Benign prostatic hyperplasia
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Breast mass
    Additional description: Breast mass
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Erectile dysfunction
    Additional description: Erectile dysfunction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Gynaecomastia
    Additional description: Gynaecomastia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Prostatitis
    Additional description: Prostatitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Vaginal haemorrhage
    Additional description: Vaginal haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    2
    Bronchial hyperreactivity
    Additional description: Bronchial hyperreactivity
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Bronchitis chronic
    Additional description: Bronchitis chronic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Bronchospasm
    Additional description: Bronchospasm
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 1306 (0.00%)
    4 / 1302 (0.31%)
         occurrences all number
    0
    4
    Cough
    Additional description: Cough
         subjects affected / exposed
    9 / 1306 (0.69%)
    8 / 1302 (0.61%)
         occurrences all number
    10
    8
    Diaphragmatic spasm
    Additional description: Diaphragmatic spasm
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    10 / 1306 (0.77%)
    6 / 1302 (0.46%)
         occurrences all number
    11
    6
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    43 / 1306 (3.29%)
    42 / 1302 (3.23%)
         occurrences all number
    46
    50
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    48 / 1306 (3.68%)
    21 / 1302 (1.61%)
         occurrences all number
    54
    22
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Hiccups
    Additional description: Hiccups
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hydrothorax
    Additional description: Hydrothorax
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hypoxia
    Additional description: Hypoxia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Nasal polyps
    Additional description: Nasal polyps
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Nocturnal dyspnoea
    Additional description: Nocturnal dyspnoea
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Orthopnoea
    Additional description: Orthopnoea
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    1
    Pulmonary fibrosis
    Additional description: Pulmonary fibrosis
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Restrictive pulmonary disease
    Additional description: Restrictive pulmonary disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract congestion
    Additional description: Respiratory tract congestion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Rhinitis allergic
    Additional description: Rhinitis allergic
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Rhinorrhoea
    Additional description: Rhinorrhoea
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Abnormal behaviour
    Additional description: Abnormal behaviour
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Anxiety
    Additional description: Anxiety
         subjects affected / exposed
    4 / 1306 (0.31%)
    4 / 1302 (0.31%)
         occurrences all number
    4
    4
    Anxiety disorder
    Additional description: Anxiety disorder
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Apathy
    Additional description: Apathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Confusional state
    Additional description: Confusional state
         subjects affected / exposed
    0 / 1306 (0.00%)
    3 / 1302 (0.23%)
         occurrences all number
    0
    3
    Depressed mood
    Additional description: Depressed mood
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Depression
    Additional description: Depression
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Disorientation
    Additional description: Disorientation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Insomnia
    Additional description: Insomnia
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences all number
    2
    3
    Mental disorder
    Additional description: Mental disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Panic attack
    Additional description: Panic attack
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Restlessness
    Additional description: Restlessness
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Sleep disorder
    Additional description: Sleep disorder
         subjects affected / exposed
    4 / 1306 (0.31%)
    0 / 1302 (0.00%)
         occurrences all number
    4
    0
    Product issues
    Device electrical impedance issue
    Additional description: Device electrical impedance issue
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Device inappropriate shock delivery
    Additional description: Device inappropriate shock delivery
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Device lead damage
    Additional description: Device lead damage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Device malfunction
    Additional description: Device malfunction
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Device occlusion
    Additional description: Device occlusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Device stimulation issue
    Additional description: Device stimulation issue
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Device lead issue
    Additional description: Device lead issue
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lead dislodgement
    Additional description: Lead dislodgement
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Thrombosis in device
    Additional description: Thrombosis in device
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Biliary colic
    Additional description: Biliary colic
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Congestive hepatopathy
    Additional description: Congestive hepatopathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hepatic pain
    Additional description: Hepatic pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hepatic cyst
    Additional description: Hepatic cyst
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hepatic cirrhosis
    Additional description: Hepatic cirrhosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Non-alcoholic steatohepatitis
    Additional description: Non-alcoholic steatohepatitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Primary biliary cholangitis
    Additional description: Primary biliary cholangitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Investigations
    Angiocardiogram
    Additional description: Angiocardiogram
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Angiogram
    Additional description: Angiogram
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Arthroscopy
    Additional description: Arthroscopy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Biopsy intestine
    Additional description: Biopsy intestine
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Biopsy prostate
    Additional description: Biopsy prostate
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Bleeding time prolonged
    Additional description: Bleeding time prolonged
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Biopsy lymph gland
    Additional description: Biopsy lymph gland
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Blood cholesterol increased
    Additional description: Blood cholesterol increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Blood creatinine increased
    Additional description: Blood creatinine increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Body temperature increased
    Additional description: Body temperature increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Blood magnesium decreased
    Additional description: Blood magnesium decreased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Bronchial aspiration procedure
    Additional description: Bronchial aspiration procedure
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Bronchoscopy abnormal
    Additional description: Bronchoscopy abnormal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Catheterisation cardiac
    Additional description: Catheterisation cardiac
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    1
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences all number
    5
    2
    Coronavirus test positive
    Additional description: Coronavirus test positive
         subjects affected / exposed
    48 / 1306 (3.68%)
    30 / 1302 (2.30%)
         occurrences all number
    49
    30
    Cystoscopy
    Additional description: Cystoscopy
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Dental examination
    Additional description: Dental examination
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Diagnostic procedure
    Additional description: Diagnostic procedure
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Echocardiogram
    Additional description: Echocardiogram
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Ejection fraction decreased
    Additional description: Ejection fraction decreased
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Echocardiogram abnormal
    Additional description: Echocardiogram abnormal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Endoscopy
    Additional description: Endoscopy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Endoscopy upper gastrointestinal tract
    Additional description: Endoscopy upper gastrointestinal tract
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Glomerular filtration rate decreased
    Additional description: Glomerular filtration rate decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Glomerular filtration rate increased
    Additional description: Glomerular filtration rate increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Haemoglobin increased
    Additional description: Haemoglobin increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Heart rate increased
    Additional description: Heart rate increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Heart rate decreased
    Additional description: Heart rate decreased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    International normalised ratio abnormal
    Additional description: International normalised ratio abnormal
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Low density lipoprotein increased
    Additional description: Low density lipoprotein increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Magnetic resonance imaging
    Additional description: Magnetic resonance imaging
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Platelet count decreased
    Additional description: Platelet count decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Prostatic specific antigen increased
    Additional description: Prostatic specific antigen increased
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Radioisotope scan
    Additional description: Radioisotope scan
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Rectal ultrasound
    Additional description: Rectal ultrasound
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Serum ferritin decreased
    Additional description: Serum ferritin decreased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Sleep study
    Additional description: Sleep study
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Spirometry
    Additional description: Spirometry
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Troponin increased
    Additional description: Troponin increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Vitamin D decreased
    Additional description: Vitamin D decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    5 / 1306 (0.38%)
    7 / 1302 (0.54%)
         occurrences all number
    5
    8
    Weight increased
    Additional description: Weight increased
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Injury, poisoning and procedural complications
    Accidental overdose
    Additional description: Accidental overdose
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences all number
    5
    1
    Animal bite
    Additional description: Animal bite
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    2
    Bone fissure
    Additional description: Bone fissure
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Clavicle fracture
    Additional description: Clavicle fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Chest injury
    Additional description: Chest injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    3
    Contusion
    Additional description: Contusion
         subjects affected / exposed
    8 / 1306 (0.61%)
    4 / 1302 (0.31%)
         occurrences all number
    8
    4
    Craniofacial fracture
    Additional description: Craniofacial fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Epicondylitis
    Additional description: Epicondylitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eye injury
    Additional description: Eye injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eyelid injury
    Additional description: Eyelid injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Face injury
    Additional description: Face injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Fall
    Additional description: Fall
         subjects affected / exposed
    32 / 1306 (2.45%)
    31 / 1302 (2.38%)
         occurrences all number
    37
    35
    Femur fracture
    Additional description: Femur fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Heat exhaustion
    Additional description: Heat exhaustion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Head injury
    Additional description: Head injury
         subjects affected / exposed
    4 / 1306 (0.31%)
    13 / 1302 (1.00%)
         occurrences all number
    5
    13
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Humerus fracture
    Additional description: Humerus fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    6 / 1302 (0.46%)
         occurrences all number
    1
    6
    Implantation complication
    Additional description: Implantation complication
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Injury
    Additional description: Injury
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Joint dislocation
    Additional description: Joint dislocation
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Joint injury
    Additional description: Joint injury
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    2
    Ligament sprain
    Additional description: Ligament sprain
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Lower limb fracture
    Additional description: Lower limb fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Limb injury
    Additional description: Limb injury
         subjects affected / exposed
    5 / 1306 (0.38%)
    7 / 1302 (0.54%)
         occurrences all number
    7
    8
    Muscle strain
    Additional description: Muscle strain
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Periorbital haematoma
    Additional description: Periorbital haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Pelvic fracture
    Additional description: Pelvic fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Periorbital haemorrhage
    Additional description: Periorbital haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Post procedural haematoma
    Additional description: Post procedural haematoma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Radius fracture
    Additional description: Radius fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    2
    Scar
    Additional description: Scar
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Shoulder fracture
    Additional description: Shoulder fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Silicosis
    Additional description: Silicosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
    Additional description: Skin laceration
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences all number
    3
    4
    Skin abrasion
    Additional description: Skin abrasion
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences all number
    2
    3
    Soft tissue injury
    Additional description: Soft tissue injury
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Spinal compression fracture
    Additional description: Spinal compression fracture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Synovial rupture
    Additional description: Synovial rupture
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Wound haemorrhage
    Additional description: Wound haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Wrist fracture
    Additional description: Wrist fracture
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    12 / 1306 (0.92%)
    8 / 1302 (0.61%)
         occurrences all number
    13
    10
    Angina unstable
    Additional description: Angina unstable
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Aortic valve stenosis
    Additional description: Aortic valve stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Arteriosclerosis coronary artery
    Additional description: Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    4 / 1306 (0.31%)
    11 / 1302 (0.84%)
         occurrences all number
    6
    11
    Atrial tachycardia
    Additional description: Atrial tachycardia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    9 / 1306 (0.69%)
    4 / 1302 (0.31%)
         occurrences all number
    10
    4
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Cardiovascular insufficiency
    Additional description: Cardiovascular insufficiency
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Cardiac failure chronic
    Additional description: Cardiac failure chronic
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    20 / 1306 (1.53%)
    18 / 1302 (1.38%)
         occurrences all number
    29
    18
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Coronary artery stenosis
    Additional description: Coronary artery stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Left ventricular dysfunction
    Additional description: Left ventricular dysfunction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Mitral valve stenosis
    Additional description: Mitral valve stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Myocardial fibrosis
    Additional description: Myocardial fibrosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    20 / 1306 (1.53%)
    7 / 1302 (0.54%)
         occurrences all number
    20
    7
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Tachyarrhythmia
    Additional description: Tachyarrhythmia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Tachycardia
    Additional description: Tachycardia
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    1
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    6 / 1306 (0.46%)
    3 / 1302 (0.23%)
         occurrences all number
    7
    3
    Nervous system disorders
    Ataxia
    Additional description: Ataxia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Axonal neuropathy
    Additional description: Axonal neuropathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Balance disorder
    Additional description: Balance disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Carotid arteriosclerosis
    Additional description: Carotid arteriosclerosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Cerebral ischaemia
    Additional description: Cerebral ischaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Cerebral small vessel ischaemic disease
    Additional description: Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Cognitive disorder
    Additional description: Cognitive disorder
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences all number
    3
    5
    Dementia
    Additional description: Dementia
         subjects affected / exposed
    3 / 1306 (0.23%)
    6 / 1302 (0.46%)
         occurrences all number
    3
    6
    Dementia Alzheimer's type
    Additional description: Dementia Alzheimer's type
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Depressed level of consciousness
    Additional description: Depressed level of consciousness
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    47 / 1306 (3.60%)
    46 / 1302 (3.53%)
         occurrences all number
    57
    52
    Dysarthria
    Additional description: Dysarthria
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Dizziness postural
    Additional description: Dizziness postural
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Facial paralysis
    Additional description: Facial paralysis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Facial paresis
    Additional description: Facial paresis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Headache
    Additional description: Headache
         subjects affected / exposed
    20 / 1306 (1.53%)
    19 / 1302 (1.46%)
         occurrences all number
    21
    21
    Hemiparesis
    Additional description: Hemiparesis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hypoaesthesia
    Additional description: Hypoaesthesia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Intracranial aneurysm
    Additional description: Intracranial aneurysm
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Lethargy
    Additional description: Lethargy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Loss of consciousness
    Additional description: Loss of consciousness
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Memory impairment
    Additional description: Memory impairment
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ophthalmic migraine
    Additional description: Ophthalmic migraine
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Parkinson's disease
    Additional description: Parkinson's disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    6 / 1306 (0.46%)
    2 / 1302 (0.15%)
         occurrences all number
    6
    2
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences all number
    3
    5
    Seizure
    Additional description: Seizure
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Somnolence
    Additional description: Somnolence
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Speech disorder
    Additional description: Speech disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    15 / 1306 (1.15%)
    11 / 1302 (0.84%)
         occurrences all number
    16
    14
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Vascular dementia
    Additional description: Vascular dementia
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    12 / 1306 (0.92%)
    8 / 1302 (0.61%)
         occurrences all number
    13
    8
    Blood disorder
    Additional description: Blood disorder
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Iron deficiency anaemia
    Additional description: Iron deficiency anaemia
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    4
    2
    Lymph node calcification
    Additional description: Lymph node calcification
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Microcytic anaemia
    Additional description: Microcytic anaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Nephrogenic anaemia
    Additional description: Nephrogenic anaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Normochromic anaemia
    Additional description: Normochromic anaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Normocytic anaemia
    Additional description: Normocytic anaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Ear and labyrinth disorders
    Auricular swelling
    Additional description: Auricular swelling
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ear pain
    Additional description: Ear pain
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Meniere's disease
    Additional description: Meniere's disease
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Tinnitus
    Additional description: Tinnitus
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Tympanic membrane perforation
    Additional description: Tympanic membrane perforation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    8 / 1306 (0.61%)
    7 / 1302 (0.54%)
         occurrences all number
    9
    8
    Eye disorders
    Amaurosis fugax
    Additional description: Amaurosis fugax
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Age-related macular degeneration
    Additional description: Age-related macular degeneration
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Blepharitis
    Additional description: Blepharitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Cataract
    Additional description: Cataract
         subjects affected / exposed
    9 / 1306 (0.69%)
    7 / 1302 (0.54%)
         occurrences all number
    11
    8
    Cataract nuclear
    Additional description: Cataract nuclear
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Charles Bonnet syndrome
    Additional description: Charles Bonnet syndrome
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Choroidal haemorrhage
    Additional description: Choroidal haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Conjunctival hyperaemia
    Additional description: Conjunctival hyperaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Conjunctival irritation
    Additional description: Conjunctival irritation
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Conjunctival haemorrhage
    Additional description: Conjunctival haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Dacryostenosis acquired
    Additional description: Dacryostenosis acquired
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Dermatochalasis
    Additional description: Dermatochalasis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences all number
    3
    3
    Eye pain
    Additional description: Eye pain
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Eye inflammation
    Additional description: Eye inflammation
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Eyelid bleeding
    Additional description: Eyelid bleeding
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Lacrimation increased
    Additional description: Lacrimation increased
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    3
    Macular degeneration
    Additional description: Macular degeneration
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Maculopathy
    Additional description: Maculopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ocular hyperaemia
    Additional description: Ocular hyperaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Optic disc haemorrhage
    Additional description: Optic disc haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Retinal detachment
    Additional description: Retinal detachment
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Retinal haemorrhage
    Additional description: Retinal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Retinal tear
    Additional description: Retinal tear
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Uveitis
    Additional description: Uveitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Vision blurred
    Additional description: Vision blurred
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Visual acuity reduced
    Additional description: Visual acuity reduced
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences all number
    8
    5
    Vitreous floaters
    Additional description: Vitreous floaters
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Vitreous haemorrhage
    Additional description: Vitreous haemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
    Additional description: Abdominal distension
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Abdominal hernia
    Additional description: Abdominal hernia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    9 / 1306 (0.69%)
    16 / 1302 (1.23%)
         occurrences all number
    9
    19
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    10 / 1306 (0.77%)
    3 / 1302 (0.23%)
         occurrences all number
    10
    3
    Anal fissure
    Additional description: Anal fissure
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Anal haemorrhage
    Additional description: Anal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
    Additional description: Aphthous ulcer
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Colitis
    Additional description: Colitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    4 / 1306 (0.31%)
    8 / 1302 (0.61%)
         occurrences all number
    5
    8
    Diaphragmatic hernia
    Additional description: Diaphragmatic hernia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    19 / 1306 (1.45%)
    20 / 1302 (1.54%)
         occurrences all number
    20
    21
    Diverticulum
    Additional description: Diverticulum
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Diverticulum intestinal
    Additional description: Diverticulum intestinal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Dry mouth
    Additional description: Dry mouth
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Duodenitis
    Additional description: Duodenitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
    Additional description: Dyspepsia
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences all number
    3
    5
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences all number
    4
    3
    Flatulence
    Additional description: Flatulence
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Frequent bowel movements
    Additional description: Frequent bowel movements
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Gastrointestinal pain
    Additional description: Gastrointestinal pain
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Gastrointestinal disorder
    Additional description: Gastrointestinal disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Gastritis erosive
    Additional description: Gastritis erosive
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Gastritis
    Additional description: Gastritis
         subjects affected / exposed
    7 / 1306 (0.54%)
    8 / 1302 (0.61%)
         occurrences all number
    7
    8
    Gingival bleeding
    Additional description: Gingival bleeding
         subjects affected / exposed
    7 / 1306 (0.54%)
    2 / 1302 (0.15%)
         occurrences all number
    7
    2
    Haematochezia
    Additional description: Haematochezia
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    5
    2
    Haemorrhoidal haemorrhage
    Additional description: Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Intestinal obstruction
    Additional description: Intestinal obstruction
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Intestinal haemorrhage
    Additional description: Intestinal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Large intestine polyp
    Additional description: Large intestine polyp
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Lower gastrointestinal haemorrhage
    Additional description: Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lip haemorrhage
    Additional description: Lip haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Mouth haemorrhage
    Additional description: Mouth haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    21 / 1306 (1.61%)
    11 / 1302 (0.84%)
         occurrences all number
    21
    11
    Oesophageal stenosis
    Additional description: Oesophageal stenosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    2
    Peritoneal cyst
    Additional description: Peritoneal cyst
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    9 / 1306 (0.69%)
    5 / 1302 (0.38%)
         occurrences all number
    9
    6
    Rectal prolapse
    Additional description: Rectal prolapse
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Rectal tenesmus
    Additional description: Rectal tenesmus
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Reflux gastritis
    Additional description: Reflux gastritis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Toothache
    Additional description: Toothache
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Trichoglossia
    Additional description: Trichoglossia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Varices oesophageal
    Additional description: Varices oesophageal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Vomiting
    Additional description: Vomiting
         subjects affected / exposed
    3 / 1306 (0.23%)
    5 / 1302 (0.38%)
         occurrences all number
    3
    5
    Skin and subcutaneous tissue disorders
    Actinic keratosis
    Additional description: Actinic keratosis
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Alopecia
    Additional description: Alopecia
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    3
    Blister
    Additional description: Blister
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Chronic papillomatous dermatitis
    Additional description: Chronic papillomatous dermatitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Decubitus ulcer
    Additional description: Decubitus ulcer
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences all number
    3
    0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Dermal cyst
    Additional description: Dermal cyst
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Dermatitis contact
    Additional description: Dermatitis contact
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Dermatosis
    Additional description: Dermatosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Hirsutism
    Additional description: Hirsutism
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hyperhidrosis
    Additional description: Hyperhidrosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Hyperkeratosis
    Additional description: Hyperkeratosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Ingrowing nail
    Additional description: Ingrowing nail
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lichen planus
    Additional description: Lichen planus
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Petechiae
    Additional description: Petechiae
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    13 / 1306 (1.00%)
    8 / 1302 (0.61%)
         occurrences all number
    13
    8
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Purpura
    Additional description: Purpura
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Rash
    Additional description: Rash
         subjects affected / exposed
    10 / 1306 (0.77%)
    9 / 1302 (0.69%)
         occurrences all number
    11
    12
    Rash pruritic
    Additional description: Rash pruritic
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Skin haemorrhage
    Additional description: Skin haemorrhage
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Skin ulcer
    Additional description: Skin ulcer
         subjects affected / exposed
    4 / 1306 (0.31%)
    2 / 1302 (0.15%)
         occurrences all number
    4
    2
    Stasis dermatitis
    Additional description: Stasis dermatitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Telangiectasia
    Additional description: Telangiectasia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Xeroderma
    Additional description: Xeroderma
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    1
    Bladder wall calcification
    Additional description: Bladder wall calcification
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    5 / 1306 (0.38%)
    0 / 1302 (0.00%)
         occurrences all number
    6
    0
    Dysuria
    Additional description: Dysuria
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    31 / 1306 (2.37%)
    8 / 1302 (0.61%)
         occurrences all number
    41
    10
    Nocturia
    Additional description: Nocturia
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Oliguria
    Additional description: Oliguria
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Polyuria
    Additional description: Polyuria
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Proteinuria
    Additional description: Proteinuria
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Renal impairment
    Additional description: Renal impairment
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Renal pain
    Additional description: Renal pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    3 / 1306 (0.23%)
    2 / 1302 (0.15%)
         occurrences all number
    3
    2
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Urinary bladder haemorrhage
    Additional description: Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Endocrine disorders
    Graves' disease
    Additional description: Graves' disease
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    4 / 1306 (0.31%)
    3 / 1302 (0.23%)
         occurrences all number
    4
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    18 / 1306 (1.38%)
    24 / 1302 (1.84%)
         occurrences all number
    23
    27
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    0 / 1306 (0.00%)
    3 / 1302 (0.23%)
         occurrences all number
    0
    3
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    11 / 1306 (0.84%)
    19 / 1302 (1.46%)
         occurrences all number
    11
    25
    Bone pain
    Additional description: Bone pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Chondrocalcinosis
    Additional description: Chondrocalcinosis
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Haematoma muscle
    Additional description: Haematoma muscle
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Joint microhaemorrhage
    Additional description: Joint microhaemorrhage
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Joint swelling
    Additional description: Joint swelling
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lumbar spinal stenosis
    Additional description: Lumbar spinal stenosis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    1
    Muscular weakness
    Additional description: Muscular weakness
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Muscle fatigue
    Additional description: Muscle fatigue
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Muscle spasms
    Additional description: Muscle spasms
         subjects affected / exposed
    6 / 1306 (0.46%)
    0 / 1302 (0.00%)
         occurrences all number
    6
    0
    Muscle twitching
    Additional description: Muscle twitching
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Mobility decreased
    Additional description: Mobility decreased
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    4 / 1306 (0.31%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Myopathy
    Additional description: Myopathy
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Neck pain
    Additional description: Neck pain
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Musculoskeletal stiffness
    Additional description: Musculoskeletal stiffness
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    9 / 1306 (0.69%)
    3 / 1302 (0.23%)
         occurrences all number
    10
    4
    Osteochondrosis
    Additional description: Osteochondrosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Osteonecrosis
    Additional description: Osteonecrosis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Osteopenia
    Additional description: Osteopenia
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Osteoporosis
    Additional description: Osteoporosis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    9 / 1306 (0.69%)
    15 / 1302 (1.15%)
         occurrences all number
    9
    16
    Periarthritis
    Additional description: Periarthritis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Polymyalgia rheumatica
    Additional description: Polymyalgia rheumatica
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Rheumatic disorder
    Additional description: Rheumatic disorder
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Spinal osteoarthritis
    Additional description: Spinal osteoarthritis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Spondylolisthesis
    Additional description: Spondylolisthesis
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Tendonitis
    Additional description: Tendonitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Vertebral lesion
    Additional description: Vertebral lesion
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bacteriuria
    Additional description: Bacteriuria
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Bronchitis
    Additional description: Bronchitis
         subjects affected / exposed
    5 / 1306 (0.38%)
    7 / 1302 (0.54%)
         occurrences all number
    5
    7
    Candida infection
    Additional description: Candida infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Cellulitis
    Additional description: Cellulitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    3
    2
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
    Additional description: Conjunctivitis
         subjects affected / exposed
    6 / 1306 (0.46%)
    2 / 1302 (0.15%)
         occurrences all number
    6
    2
    Cystitis
    Additional description: Cystitis
         subjects affected / exposed
    5 / 1306 (0.38%)
    2 / 1302 (0.15%)
         occurrences all number
    6
    2
    Dacryocystitis
    Additional description: Dacryocystitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    2
    1
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    3 / 1306 (0.23%)
    0 / 1302 (0.00%)
         occurrences all number
    4
    0
    Ear infection fungal
    Additional description: Ear infection fungal
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Endocarditis
    Additional description: Endocarditis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    2 / 1306 (0.15%)
    2 / 1302 (0.15%)
         occurrences all number
    2
    2
    Eye infection
    Additional description: Eye infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    2
    Folliculitis
    Additional description: Folliculitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Gastroenteritis viral
    Additional description: Gastroenteritis viral
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Fungal skin infection
    Additional description: Fungal skin infection
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Fungal infection
    Additional description: Fungal infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    3 / 1302 (0.23%)
         occurrences all number
    1
    3
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences all number
    2
    3
    Infected dermal cyst
    Additional description: Infected dermal cyst
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Implant site infection
    Additional description: Implant site infection
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Impetigo
    Additional description: Impetigo
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Influenza
    Additional description: Influenza
         subjects affected / exposed
    1 / 1306 (0.08%)
    1 / 1302 (0.08%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
    Additional description: Lower respiratory tract infection
         subjects affected / exposed
    3 / 1306 (0.23%)
    6 / 1302 (0.46%)
         occurrences all number
    3
    8
    Liver abscess
    Additional description: Liver abscess
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Lyme disease
    Additional description: Lyme disease
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Nasopharyngitis
    Additional description: Nasopharyngitis
         subjects affected / exposed
    6 / 1306 (0.46%)
    11 / 1302 (0.84%)
         occurrences all number
    6
    11
    Orchitis
    Additional description: Orchitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    5 / 1306 (0.38%)
    4 / 1302 (0.31%)
         occurrences all number
    5
    4
    Pulpitis dental
    Additional description: Pulpitis dental
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    4
    0
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    6 / 1306 (0.46%)
    8 / 1302 (0.61%)
         occurrences all number
    6
    11
    Rhinitis
    Additional description: Rhinitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
    Additional description: Sinusitis
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Tinea pedis
    Additional description: Tinea pedis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Tooth infection
    Additional description: Tooth infection
         subjects affected / exposed
    2 / 1306 (0.15%)
    3 / 1302 (0.23%)
         occurrences all number
    2
    3
    Upper respiratory tract infection
    Additional description: Upper respiratory tract infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    5 / 1302 (0.38%)
         occurrences all number
    1
    5
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    18 / 1306 (1.38%)
    19 / 1302 (1.46%)
         occurrences all number
    33
    24
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    3
    Vestibular neuronitis
    Additional description: Vestibular neuronitis
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Cachexia
    Additional description: Cachexia
         subjects affected / exposed
    1 / 1306 (0.08%)
    2 / 1302 (0.15%)
         occurrences all number
    1
    2
    Decreased appetite
    Additional description: Decreased appetite
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    7 / 1306 (0.54%)
    4 / 1302 (0.31%)
         occurrences all number
    7
    4
    Folate deficiency
    Additional description: Folate deficiency
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Gout
    Additional description: Gout
         subjects affected / exposed
    3 / 1306 (0.23%)
    4 / 1302 (0.31%)
         occurrences all number
    3
    4
    Hypercholesterolaemia
    Additional description: Hypercholesterolaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hyperlipidaemia
    Additional description: Hyperlipidaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hypertriglyceridaemia
    Additional description: Hypertriglyceridaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Hyperuricaemia
    Additional description: Hyperuricaemia
         subjects affected / exposed
    3 / 1306 (0.23%)
    3 / 1302 (0.23%)
         occurrences all number
    3
    3
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    2 / 1306 (0.15%)
    0 / 1302 (0.00%)
         occurrences all number
    2
    0
    Impaired fasting glucose
    Additional description: Impaired fasting glucose
         subjects affected / exposed
    0 / 1306 (0.00%)
    1 / 1302 (0.08%)
         occurrences all number
    0
    1
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    1 / 1306 (0.08%)
    0 / 1302 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency
    Additional description: Iron deficiency
         subjects affected / exposed
    3 / 1306 (0.23%)
    1 / 1302 (0.08%)
         occurrences all number
    4
    1
    Type 2 diabetes mellitus
    Additional description: Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 1306 (0.00%)
    2 / 1302 (0.15%)
         occurrences all number
    0
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2017
    • CHA2DS2VASc as used within NOAH and defined in section inclusion criteria does not contain female sex (modified CHA2DS2VASc score) • Correction of typographical error: pglycoprotein inhibitors instead of glycoprotein p inhibitors • The Steering Committee decided to add the secondary outcome parameter Major Adverse Cardiac Events [MACEs] (cardiac death, myocardial infarction, acute coronary syndrome) to allow direct comparison with outcome of other published studies (e.g. RELY and ENGAGE). • Harmonisation of protocol versions by adding the legal exclusion criterion (applicable in countries where legally required): “E.12. All persons exempt from participation in a clinical trial by law.” which was requested by the French ethics committee and included in the protocol version 10.10.2016 that was valid in France, only. • Adaption of storage conditions for study medication from 1-25°C to 2-25°C. • SmPC is used as reference throughout the entire study protocol. • Definition of temporary discontinuation of study medication in case of clinical indication for temporary antiplatelet agent prescription in addition to study medication (≤ 6 months duration) • Adaption of allowed time window for scheduled follow-up visits from +/- 1 month to +/-2 weeks with regard to logistics of study medication as IMP is being provided in units, each sufficient for 6 months plus 14 days reserve. • Actual weight is part of every physical examination and also needed to determine the adequate dosage of the IMP. Measuring body weight was explicitly added to the measures of the baseline and drug/device visits. • Addition of a fourth member of the Endpoint Review Committee (ERC) to facilitate timely adjudication of SAEs and to ensure greater flexibility in case of temporary unavailability of an ERC member.
    27 Apr 2018
    • The modified CHA2DS2VASc score definitions were adapted to guideline definitions in one point in order to make results comparable to other clinical trials. “Previous myocardial infection” was added to the subgroup of vascular diseases. • Reduction of total number of patients needed from 3,400 to 2,686 as a consequence of prolonged mean follow-up period. In addition it was clarified that the expected number of patients is described as patients who have been randomised and took at least one does of study drug (randomised and treated). • Prolongation of recruitment duration after recalculation by the study statistician also prolonged follow-up time of already included patients. • Generalisation of I2. and I3. as patients are selected during clinical routine visits and the device settings are according to clinical routine care. By protocol definitions any AHRE detected by the device in the past is valid if the atrial rate is ≥ 180 bpm and the duration ≥ 6 min.
    06 Nov 2018
    The use of defibrillator and insertable cardiac monitor were amended to main inclusion criteria for study population. • Definition of AHRE was reduced to > 170 bmp atrial rate. • Secondary outcome parameter: Major Adverse Cardiac Events was specified to cardiovascular death, myocardial infarction, acute coronary syndrome, PCI, CABG. • Secondary outcome parameter: storke or systemic arterial embolism was added. • Safety analysis will be perfomed with all patients enrolled.
    01 Dec 2019
    • Number of patients was reduced to randomised and treated 2,538 patients. • Number or primary endpoints was reduced to n= 220. • Recruitment period was expanded to n= 71 months. • Maximum follow up time was increased to n= 83 months. • Total study duration was increased to n= 90 months.
    01 Oct 2020
    • Measures to be taken in case of pandemic was added.

    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.
    The trial does not have sufficient power to detect or rule out a small beneficial effect of oral anticoagulation on the prevention of stroke. The generalizability of these findings with edoxaban to other NOACs is not known.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/37622677
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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