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    Clinical Trial Results:
    Early treatment of Atrial fibrillation for Stroke prevention Trial (EAST)

    Summary
    EudraCT number
    		 2010-021258-20
    Trial protocol
    		 DE   DK   NL   CZ   BE   ES   PL   IT  
    Global end of trial date
    29 May 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 May 2022
    First version publication date
    27 May 2022
    Other versions
    Summary report(s)
    		 Final study report - EAST - AFNET 4 - 2010-021258-20

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EAST-AFNET 4
    Additional study identifiers
    ISRCTN number
    		 ISRCTN04708680
    US NCT number
    		 NCT01288352
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Kompetenznetz Vorhofflimmern e.V. (AFNET)
    Sponsor organisation address
    Mendelstraße 11 , Münster, Germany, 48149
    Public contact
    Clinical Trials Information, Kompetenznetz Vorhofflimmern e.V. (AFNET), +49 251980 1340, info@kompetenznetz-vorhofflimmern.de
    Scientific contact
    Clinical Trials Information, Kompetenznetz Vorhofflimmern e.V. (AFNET), +49 251980 1340, 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
    29 May 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 May 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To test whether an early and comprehensive rhythm control therapy can prevent adverse cardiovascular outcomes in patients with atrial fibrillation (AF) compared to usual care.
    Protection of trial subjects
    No IMP was in use. Risk-Assessment regarding Covid-19-Pandemic: Due to End of Observation being set to 06.03.2020 and to collection of last FU information via postal questionnaires (no personal visits), the safety of study participants was not affected by the current pandemic.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jun 2011
    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
    Netherlands: 180
    Country: Number of subjects enrolled
    Poland: 163
    Country: Number of subjects enrolled
    Spain: 129
    Country: Number of subjects enrolled
    Belgium: 143
    Country: Number of subjects enrolled
    Czechia: 35
    Country: Number of subjects enrolled
    Denmark: 53
    Country: Number of subjects enrolled
    Germany: 1664
    Country: Number of subjects enrolled
    Italy: 125
    Country: Number of subjects enrolled
    United Kingdom: 248
    Country: Number of subjects enrolled
    Switzerland: 46
    Country: Number of subjects enrolled
    France: 3
    Worldwide total number of subjects
    2789
    EEA total number of subjects
    2495
    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)
    585
    From 65 to 84 years
    2127
    85 years and over
    77

    Subject disposition

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    Recruitment
    Recruitment details
    		 We enrolled adults (≥18 years of age) who had early AF (defined as atrial fibrillation diagnosed ≤12 months before enrolment) and who were older than 75 years of age, have had a previous transient ischemic attack (TIA) or stroke, or met two of the following criteria: age greater than 65 years, female sex, heart failure, hypertension, diabetes

    Pre-assignment
    Screening details
    		 Recent onset AF, i.e. AF with known history of <= 1 year prior to random Risk for stroke by EITHER a) 1 of the following: age > 75 , prior stroke or transient ischemic attack OR b) 2 of the following: hypertension, diabetes mell, left ventricular hypertrophy, age >65, fem sex, peripheral artery dis, kidney dis, stable heart fail, s cor a di

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Early treatment
    Arm description
    		 Patients will receive either catheter ablation, or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be decided by the local investigator. Upon recurrence of AF, both modalities will be combined.
    Arm type
    		 Experimental

    Investigational medicinal product name
    adequate antiarrhythmic therapy
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    acccording instructrions In Germany, Denmark, and Switzerland antiarrhythmic drugs (amiodarone, dronedarone, flecainide and propafenone) are considered investigational drugs whereas in the other countries these are not considered investigational drugs.

    Arm title
    		 Usual care
    Arm description
    		 conducted following the current ESC guidelines for AF treatment.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Early treatment Usual care
    Started
    1395
    1394
    Completed
    1395
    1394

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Early treatment
    Reporting group description
    		 Patients will receive either catheter ablation, or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be decided by the local investigator. Upon recurrence of AF, both modalities will be combined.

    Reporting group title
    Usual care
    Reporting group description
    		 conducted following the current ESC guidelines for AF treatment.

    Reporting group values
    		 Early treatment Usual care Total
    Number of subjects
    		 1395 1394 2789
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 306 279 585
        From 65-84 years
    		 1045 1082 2127
        85 years and over
    		 44 33 77
    Gender categorical
    Units: Subjects
        Female
    		 645 648 1293
        Male
    		 750 746 1496

    End points

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    End points reporting groups
    Reporting group title
    Early treatment
    Reporting group description
    		 Patients will receive either catheter ablation, or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be decided by the local investigator. Upon recurrence of AF, both modalities will be combined.

    Reporting group title
    Usual care
    Reporting group description
    		 conducted following the current ESC guidelines for AF treatment.

    Primary: First Primary Outcome

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    End point title
    		 First Primary Outcome
    End point description
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 Early treatment Usual care
    Number of subjects analysed
    1395
    1394
    Units: Incidences
    249
    316
    Statistical analysis title
    		 Regression analysis 1st primary outcome
    Comparison groups
    Usual care v Early treatment
    Number of subjects included in analysis
    2789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.004
    Method
    		 Regression, Cox
    Confidence interval

    Primary: Cardio vascular Death

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    End point title
    		 Cardio vascular Death
    End point description
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 Early treatment Usual care
    Number of subjects analysed
    1395
    1394
    Units: Incidences
    67
    94
    Statistical analysis title
    		 Regression analysis
    Comparison groups
    Early treatment v Usual care
    Number of subjects included in analysis
    2789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Regression, Cox
    Confidence interval

    Primary: Stroke

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    End point title
    		 Stroke
    End point description
    End point type
    Primary
    End point timeframe
    Overalll Trial
    End point values
    		 Early treatment Usual care
    Number of subjects analysed
    1395
    1394
    Units: Incidences
    40
    62
    Statistical analysis title
    		 Regression analysis Stroke
    Comparison groups
    Early treatment v Usual care
    Number of subjects included in analysis
    2789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035
    Method
    		 Regression, Cox
    Confidence interval

    Primary: Worsening of Heart Failure

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    End point title
    		 Worsening of Heart Failure
    End point description
    End point type
    Primary
    End point timeframe
    Overall trial
    End point values
    		 Early treatment Usual care
    Number of subjects analysed
    1395
    1394
    Units: IIncidences
    139
    169
    Statistical analysis title
    		 Regression analysis heart Failure
    Comparison groups
    Early treatment v Usual care
    Number of subjects included in analysis
    2789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.073
    Method
    		 Regression, Cox
    Confidence interval

    Primary: Acute Coronary Syndrome

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    End point title
    		 Acute Coronary Syndrome
    End point description
    End point type
    Primary
    End point timeframe
    Overall Trial
    End point values
    		 Early treatment Usual care
    Number of subjects analysed
    1395
    1394
    Units: Incidences
    53
    65
    Statistical analysis title
    		 Regression analysis Corobary Heart Syndrome
    Comparison groups
    Early treatment v Usual care
    Number of subjects included in analysis
    2789
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.309
    Method
    		 Regression, Cox
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Timeframe for AE
    Adverse event reporting additional description
    AE additional description
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Early rhythm control
    Reporting group description
    		 -

    Reporting group title
    Usual care
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The trial tests a therapeutic strategy evaluating approved therapies in their approved indication. Therefore, the collection of adverse events was limited to SUSARs and to events related to the intervention. Details have been published in the trial protocol (refer to NEJM online appendix).
    Serious adverse events
    		 Early rhythm control Usual care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    978 / 1395 (70.11%)
    999 / 1394 (71.66%)
         number of deaths (all causes)
    138
    165
         number of deaths resulting from adverse events
    138
    165
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Abdominal neoplasm
    Additional description: Abdominal neoplasm
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute lymphocytic leukaemia
    Additional description: Acute lymphocytic leukaemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myeloid leukaemia
    Additional description: Acute myeloid leukaemia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma gastric
    Additional description: Adenocarcinoma gastric
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenoma benign
    Additional description: Adenoma benign
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal adenoma
    Additional description: Adrenal adenoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal cancer
    Additional description: Anal cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Angiosarcoma
    Additional description: Angiosarcoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Basal cell carcinoma
    Additional description: Basal cell carcinoma
         subjects affected / exposed
    5 / 1395 (0.36%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basosquamous carcinoma of skin
    Additional description: Basosquamous carcinoma of skin
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder adenocarcinoma stage unspecified
    Additional description: Bladder adenocarcinoma stage unspecified
         subjects affected / exposed
    3 / 1395 (0.22%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder cancer
    Additional description: Bladder cancer
         subjects affected / exposed
    8 / 1395 (0.57%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm
    Additional description: Brain neoplasm
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
    Additional description: Breast cancer
         subjects affected / exposed
    10 / 1395 (0.72%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bronchial carcinoma
    Additional description: Bronchial carcinoma
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carcinoid tumour
    Additional description: Carcinoid tumour
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoma in situ
    Additional description: Carcinoma in situ
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac myxoma
    Additional description: Cardiac myxoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central nervous system lymphoma
    Additional description: Central nervous system lymphoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervix carcinoma
    Additional description: Cervix carcinoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
    Additional description: Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.72%)
    17 / 1394 (1.22%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 19
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Colorectal cancer
    Additional description: Colorectal cancer
         subjects affected / exposed
    4 / 1395 (0.29%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Endometrial cancer
    Additional description: Endometrial cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gallbladder cancer
    Additional description: Gallbladder cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder cancer metastatic
    Additional description: Gallbladder cancer metastatic
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric cancer
    Additional description: Gastric cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal neoplasm
    Additional description: Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
    Additional description: Glioblastoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hairy cell leukaemia
    Additional description: Hairy cell leukaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer
    Additional description: Hepatic cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular carcinoma
    Additional description: Hepatocellular carcinoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal adenocarcinoma
    Additional description: Intestinal adenocarcinoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
    Additional description: Laryngeal cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukaemia
    Additional description: Leukaemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip and/or oral cavity cancer
    Additional description: Lip and/or oral cavity cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
    Additional description: Lung adenocarcinoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
    Additional description: Lung cancer metastatic
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
    Additional description: Lung neoplasm
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
    Additional description: Lung neoplasm malignant
         subjects affected / exposed
    10 / 1395 (0.72%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 22
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    Lymphoma
    Additional description: Lymphoma
         subjects affected / exposed
    3 / 1395 (0.22%)
    8 / 1394 (0.57%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Malignant ascites
    Additional description: Malignant ascites
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant melanoma
    Additional description: Malignant melanoma
         subjects affected / exposed
    3 / 1395 (0.22%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of thymus
    Additional description: Malignant neoplasm of thymus
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of uterine adnexa
    Additional description: Malignant neoplasm of uterine adnexa
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinum neoplasm
    Additional description: Mediastinum neoplasm
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Meningioma benign
    Additional description: Meningioma benign
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma
    Additional description: Mesothelioma
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to lung
    Additional description: Metastases to lung
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
    Additional description: Metastasis
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic neoplasm
    Additional description: Metastatic neoplasm
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic syndrome
    Additional description: Myelodysplastic syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neoplasm malignant
    Additional description: Neoplasm malignant
         subjects affected / exposed
    1 / 1395 (0.07%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Neoplasm skin
    Additional description: Neoplasm skin
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
    Additional description: Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurofibrosarcoma
    Additional description: Neurofibrosarcoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal carcinoma
    Additional description: Oesophageal carcinoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
    Additional description: Ovarian cancer
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pancreatic carcinoma
    Additional description: Pancreatic carcinoma
         subjects affected / exposed
    9 / 1395 (0.65%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 43
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Pancreatic carcinoma metastatic
    Additional description: Pancreatic carcinoma metastatic
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Penile cancer
    Additional description: Penile cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
    Additional description: Plasma cell myeloma
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
    Additional description: Prostate cancer
         subjects affected / exposed
    18 / 1395 (1.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Prostate cancer metastatic
    Additional description: Prostate cancer metastatic
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
    Additional description: Prostatic adenoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal adenocarcinoma
    Additional description: Rectal adenocarcinoma
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
    Additional description: Rectal cancer
         subjects affected / exposed
    6 / 1395 (0.43%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
    Additional description: Renal cancer
         subjects affected / exposed
    6 / 1395 (0.43%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salivary gland neoplasm
    Additional description: Salivary gland neoplasm
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer
    Additional description: Skin cancer
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cancer metastatic
    Additional description: Skin cancer metastatic
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine carcinoma
    Additional description: Small intestine carcinoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft tissue neoplasm
    Additional description: Soft tissue neoplasm
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of pharynx
    Additional description: Squamous cell carcinoma of pharynx
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid adenoma
    Additional description: Thyroid adenoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer
    Additional description: Thyroid cancer
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil cancer
    Additional description: Tonsil cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
    Additional description: Transitional cell carcinoma
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urethral cancer
    Additional description: Urethral cancer
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine cancer
    Additional description: Uterine cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval cancer
    Additional description: Vulval cancer
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
    Additional description: Aortic aneurysm
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic dissection
    Additional description: Aortic dissection
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Aortic stenosis
    Additional description: Aortic stenosis
         subjects affected / exposed
    3 / 1395 (0.22%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula
    Additional description: Arteriovenous fistula
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
    Additional description: Circulatory collapse
         subjects affected / exposed
    3 / 1395 (0.22%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
    Additional description: Deep vein thrombosis
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
    Additional description: Embolism arterial
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haematoma
    Additional description: Haematoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
    Additional description: Haemorrhage
         subjects affected / exposed
    73 / 1395 (5.23%)
    83 / 1394 (5.95%)
         occurrences causally related to treatment / all
    1 / 81
    1 / 97
         deaths causally related to treatment / all
    0 / 0
    0 / 10
    Hypertension
    Additional description: Hypertension
         subjects affected / exposed
    34 / 1395 (2.44%)
    41 / 1394 (2.94%)
         occurrences causally related to treatment / all
    1 / 36
    0 / 49
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
    Additional description: Hypertensive crisis
         subjects affected / exposed
    11 / 1395 (0.79%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
    Additional description: Hypotension
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
    Additional description: Iliac artery stenosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
    Additional description: Peripheral arterial occlusive disease
         subjects affected / exposed
    3 / 1395 (0.22%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
    Additional description: Peripheral embolism
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral ischaemia
    Additional description: Peripheral ischaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post thrombotic syndrome
    Additional description: Post thrombotic syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renovascular hypertension
    Additional description: Renovascular hypertension
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
    Additional description: Temporal arteritis
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
    Additional description: Thrombophlebitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
    Additional description: Vasculitis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Abdominal operation
    Additional description: Abdominal operation
         subjects affected / exposed
    5 / 1395 (0.36%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenalectomy
    Additional description: Adrenalectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol detoxification
    Additional description: Alcohol detoxification
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol rehabilitation
    Additional description: Alcohol rehabilitation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allogenic bone marrow transplantation therapy
    Additional description: Allogenic bone marrow transplantation therapy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioplasty
    Additional description: Angioplasty
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle operation
    Additional description: Ankle operation
         subjects affected / exposed
    5 / 1395 (0.36%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anorectal operation
    Additional description: Anorectal operation
         subjects affected / exposed
    5 / 1395 (0.36%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm repair
    Additional description: Aortic aneurysm repair
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve replacement
    Additional description: Aortic valve replacement
         subjects affected / exposed
    4 / 1395 (0.29%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicectomy
    Additional description: Appendicectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial repair
    Additional description: Arterial repair
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula operation
    Additional description: Arteriovenous fistula operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrodesis
    Additional description: Arthrodesis
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthroscopic surgery
    Additional description: Arthroscopic surgery
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Artificial urinary sphincter implant
    Additional description: Artificial urinary sphincter implant
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atherectomy
    Additional description: Atherectomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial septal defect repair
    Additional description: Atrial septal defect repair
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Baker's cyst excision
    Additional description: Baker's cyst excision
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stent removal
    Additional description: Bile duct stent removal
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm surgery
    Additional description: Bladder neoplasm surgery
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder operation
    Additional description: Bladder operation
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caesarean section
    Additional description: Caesarean section
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ablation
    Additional description: Cardiac ablation
         subjects affected / exposed
    27 / 1395 (1.94%)
    20 / 1394 (1.43%)
         occurrences causally related to treatment / all
    4 / 27
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac operation
    Additional description: Cardiac operation
         subjects affected / exposed
    15 / 1395 (1.08%)
    14 / 1394 (1.00%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker insertion
    Additional description: Cardiac pacemaker insertion
         subjects affected / exposed
    88 / 1395 (6.31%)
    83 / 1394 (5.95%)
         occurrences causally related to treatment / all
    11 / 90
    4 / 88
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac pacemaker replacement
    Additional description: Cardiac pacemaker replacement
         subjects affected / exposed
    6 / 1395 (0.43%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac resynchronisation therapy
    Additional description: Cardiac resynchronisation therapy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardioversion
    Additional description: Cardioversion
         subjects affected / exposed
    225 / 1395 (16.13%)
    223 / 1394 (16.00%)
         occurrences causally related to treatment / all
    4 / 357
    5 / 390
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid endarterectomy
    Additional description: Carotid endarterectomy
         subjects affected / exposed
    6 / 1395 (0.43%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract operation
    Additional description: Cataract operation
         subjects affected / exposed
    11 / 1395 (0.79%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Central venous catheterisation
    Additional description: Central venous catheterisation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polypectomy
    Additional description: Cervical polypectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemotherapy
    Additional description: Chemotherapy
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
    Additional description: Cholecystectomy
         subjects affected / exposed
    16 / 1395 (1.15%)
    17 / 1394 (1.22%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circumcision
    Additional description: Circumcision
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon operation
    Additional description: Colon operation
         subjects affected / exposed
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colostomy
    Additional description: Colostomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary angioplasty
    Additional description: Coronary angioplasty
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
    Additional description: Coronary artery bypass
         subjects affected / exposed
    14 / 1395 (1.00%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cox-Maze procedure
    Additional description: Cox-Maze procedure
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dacryocystorhinostomy
    Additional description: Dacryocystorhinostomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Debridement
    Additional description: Debridement
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Elbow operation
    Additional description: Elbow operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endarterectomy
    Additional description: Endarterectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterostomy
    Additional description: Enterostomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye operation
    Additional description: Eye operation
         subjects affected / exposed
    8 / 1395 (0.57%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid operation
    Additional description: Eyelid operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot operation
    Additional description: Foot operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foraminotomy
    Additional description: Foraminotomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric operation
    Additional description: Gastric operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal surgery
    Additional description: Gastrointestinal surgery
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrostomy
    Additional description: Gastrostomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma surgery
    Additional description: Glaucoma surgery
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoid operation
    Additional description: Haemorrhoid operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve operation
    Additional description: Heart valve operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart valve replacement
    Additional description: Heart valve replacement
         subjects affected / exposed
    11 / 1395 (0.79%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia repair
    Additional description: Hernia repair
         subjects affected / exposed
    13 / 1395 (0.93%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip arthroplasty
    Additional description: Hip arthroplasty
         subjects affected / exposed
    42 / 1395 (3.01%)
    43 / 1394 (3.08%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 47
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip surgery
    Additional description: Hip surgery
         subjects affected / exposed
    9 / 1395 (0.65%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele operation
    Additional description: Hydrocele operation
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysterectomy
    Additional description: Hysterectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ileostomy
    Additional description: Ileostomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator insertion
    Additional description: Implantable defibrillator insertion
         subjects affected / exposed
    1 / 1395 (0.07%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable defibrillator replacement
    Additional description: Implantable defibrillator replacement
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    7 / 1395 (0.50%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc operation
    Additional description: Intervertebral disc operation
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal operation
    Additional description: Intestinal operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-cerebral aneurysm operation
    Additional description: Intra-cerebral aneurysm operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint arthroplasty
    Additional description: Joint arthroplasty
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint resurfacing surgery
    Additional description: Joint resurfacing surgery
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratomileusis
    Additional description: Keratomileusis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee arthroplasty
    Additional description: Knee arthroplasty
         subjects affected / exposed
    36 / 1395 (2.58%)
    39 / 1394 (2.80%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 46
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee operation
    Additional description: Knee operation
         subjects affected / exposed
    19 / 1395 (1.36%)
    26 / 1394 (1.87%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laparotomy
    Additional description: Laparotomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal polypectomy
    Additional description: Large intestinal polypectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal operation
    Additional description: Laryngeal operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb operation
    Additional description: Limb operation
         subjects affected / exposed
    6 / 1395 (0.43%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lithotripsy
    Additional description: Lithotripsy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm surgery
    Additional description: Lung neoplasm surgery
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mammoplasty
    Additional description: Mammoplasty
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastectomy
    Additional description: Mastectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device removal
    Additional description: Medical device removal
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma surgery
    Additional description: Meningioma surgery
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus operation
    Additional description: Meniscus operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus removal
    Additional description: Meniscus removal
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic surgery
    Additional description: Metabolic surgery
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve repair
    Additional description: Mitral valve repair
         subjects affected / exposed
    5 / 1395 (0.36%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve replacement
    Additional description: Mitral valve replacement
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal operation
    Additional description: Nasal operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectomy
    Additional description: Nephrectomy
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopaedic procedure
    Additional description: Orthopaedic procedure
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otorhinolaryngological surgery
    Additional description: Otorhinolaryngological surgery
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatectomy
    Additional description: Pancreatectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroidectomy
    Additional description: Parathyroidectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotidectomy
    Additional description: Parotidectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic floor repair
    Additional description: Pelvic floor repair
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    65 / 1395 (4.66%)
    57 / 1394 (4.09%)
         occurrences causally related to treatment / all
    0 / 77
    0 / 69
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery angioplasty
    Additional description: Peripheral artery angioplasty
         subjects affected / exposed
    18 / 1395 (1.29%)
    23 / 1394 (1.65%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery bypass
    Additional description: Peripheral artery bypass
         subjects affected / exposed
    1 / 1395 (0.07%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral endarterectomy
    Additional description: Peripheral endarterectomy
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebectomy
    Additional description: Phlebectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary tumour removal
    Additional description: Pituitary tumour removal
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plastic surgery
    Additional description: Plastic surgery
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurectomy
    Additional description: Pleurectomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polypectomy
    Additional description: Polypectomy
         subjects affected / exposed
    7 / 1395 (0.50%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatectomy
    Additional description: Prostatectomy
         subjects affected / exposed
    5 / 1395 (0.36%)
    14 / 1394 (1.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic operation
    Additional description: Prostatic operation
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radioactive iodine therapy
    Additional description: Radioactive iodine therapy
         subjects affected / exposed
    5 / 1395 (0.36%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiotherapy
    Additional description: Radiotherapy
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal prolapse repair
    Additional description: Rectal prolapse repair
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal stone removal
    Additional description: Renal stone removal
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal surgery
    Additional description: Renal surgery
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Resuscitation
    Additional description: Resuscitation
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinoplasty
    Additional description: Rhinoplasty
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland operation
    Additional description: Salivary gland operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingo-oophorectomy
    Additional description: Salpingo-oophorectomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder arthroplasty
    Additional description: Shoulder arthroplasty
         subjects affected / exposed
    4 / 1395 (0.29%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder operation
    Additional description: Shoulder operation
         subjects affected / exposed
    6 / 1395 (0.43%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus operation
    Additional description: Sinus operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin cosmetic procedure
    Additional description: Skin cosmetic procedure
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin graft
    Additional description: Skin graft
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin neoplasm excision
    Additional description: Skin neoplasm excision
         subjects affected / exposed
    5 / 1395 (0.36%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin operation
    Additional description: Skin operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal laminectomy
    Additional description: Spinal laminectomy
         subjects affected / exposed
    4 / 1395 (0.29%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal operation
    Additional description: Spinal operation
         subjects affected / exposed
    18 / 1395 (1.29%)
    23 / 1394 (1.65%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery
    Additional description: Surgery
         subjects affected / exposed
    2 / 1395 (0.14%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon operation
    Additional description: Tendon operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Therapeutic embolisation
    Additional description: Therapeutic embolisation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombectomy
    Additional description: Thrombectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thromboembolectomy
    Additional description: Thromboembolectomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroidectomy
    Additional description: Thyroidectomy
         subjects affected / exposed
    4 / 1395 (0.29%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe amputation
    Additional description: Toe amputation
         subjects affected / exposed
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe operation
    Additional description: Toe operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillectomy
    Additional description: Tonsillectomy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth extraction
    Additional description: Tooth extraction
         subjects affected / exposed
    4 / 1395 (0.29%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy tube removal
    Additional description: Tracheostomy tube removal
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral prostatectomy
    Additional description: Transurethral prostatectomy
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid valve repair
    Additional description: Tricuspid valve repair
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanoplasty
    Additional description: Tympanoplasty
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia repair
    Additional description: Umbilical hernia repair
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral caruncle removal
    Additional description: Urethral caruncle removal
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral operation
    Additional description: Urethral operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethrotomy
    Additional description: Urethrotomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract operation
    Additional description: Urinary tract operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine operation
    Additional description: Uterine operation
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal operation
    Additional description: Vaginal operation
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein operation
    Additional description: Varicose vein operation
         subjects affected / exposed
    11 / 1395 (0.79%)
    9 / 1394 (0.65%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular septal defect repair
    Additional description: Ventricular septal defect repair
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebroplasty
    Additional description: Vertebroplasty
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitrectomy
    Additional description: Vitrectomy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord nodule removal
    Additional description: Vocal cord nodule removal
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound treatment
    Additional description: Wound treatment
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist surgery
    Additional description: Wrist surgery
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
    Additional description: Asthenia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
    Additional description: Cardiac death
         subjects affected / exposed
    19 / 1395 (1.36%)
    22 / 1394 (1.58%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 22
         deaths causally related to treatment / all
    0 / 19
    0 / 21
    Catheter site haemorrhage
    Additional description: Catheter site haemorrhage
         subjects affected / exposed
    8 / 1395 (0.57%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    5 / 8
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
    Additional description: Chest pain
         subjects affected / exposed
    25 / 1395 (1.79%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
    Additional description: Death
         subjects affected / exposed
    109 / 1395 (7.81%)
    131 / 1394 (9.40%)
         occurrences causally related to treatment / all
    0 / 109
    1 / 131
         deaths causally related to treatment / all
    0 / 109
    1 / 131
    Discomfort
    Additional description: Discomfort
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extravasation
    Additional description: Extravasation
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait disturbance
    Additional description: Gait disturbance
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
    Additional description: General physical health deterioration
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
    Additional description: Hernia
         subjects affected / exposed
    7 / 1395 (0.50%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
    Additional description: Hypothermia
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Impaired healing
    Additional description: Impaired healing
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
    Additional description: Multiple organ dysfunction syndrome
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Necrosis
    Additional description: Necrosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema
    Additional description: Oedema
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
    Additional description: Oedema peripheral
         subjects affected / exposed
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pacemaker generated arrhythmia
    Additional description: Pacemaker generated arrhythmia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
    Additional description: Pain
         subjects affected / exposed
    1 / 1395 (0.07%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    Additional description: Pyrexia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
    Additional description: Stent-graft endoleak
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Strangulated hernia
    Additional description: Strangulated hernia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
    Additional description: Sudden cardiac death
         subjects affected / exposed
    8 / 1395 (0.57%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 8
    0 / 11
    Sudden death
    Additional description: Sudden death
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Vascular stent thrombosis
    Additional description: Vascular stent thrombosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Amyloidosis
    Additional description: Amyloidosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
    Additional description: Drug hypersensitivity
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
    Additional description: Hypersensitivity
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         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
    4 / 1395 (0.29%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
    Additional description: Female genital tract fistula
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic pain
    Additional description: Pelvic pain
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
    Additional description: Acute respiratory failure
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
    Additional description: Asthma
         subjects affected / exposed
    5 / 1395 (0.36%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
    Additional description: Atelectasis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopulmonary disease
    Additional description: Bronchopulmonary disease
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
    Additional description: Chronic obstructive pulmonary disease
         subjects affected / exposed
    24 / 1395 (1.72%)
    28 / 1394 (2.01%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Dyspnoea
    Additional description: Dyspnoea
         subjects affected / exposed
    15 / 1395 (1.08%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
    Additional description: Dyspnoea exertional
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
    Additional description: Epistaxis
         subjects affected / exposed
    5 / 1395 (0.36%)
    9 / 1394 (0.65%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
    Additional description: Haemoptysis
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         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
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiccups
    Additional description: Hiccups
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
    Additional description: Hyperventilation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
    Additional description: Interstitial lung disease
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infiltration
    Additional description: Lung infiltration
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
    Additional description: Pleural effusion
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
    Additional description: Pneumonia aspiration
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumothorax
    Additional description: Pneumothorax
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
    Additional description: Pulmonary embolism
         subjects affected / exposed
    11 / 1395 (0.79%)
    8 / 1394 (0.57%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Pulmonary fibrosis
    Additional description: Pulmonary fibrosis
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary hypertension
    Additional description: Pulmonary hypertension
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
    Additional description: Pulmonary oedema
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sarcoidosis
    Additional description: Pulmonary sarcoidosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
    Additional description: Respiratory failure
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
    Additional description: Sleep apnoea syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord disorder
    Additional description: Vocal cord disorder
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol withdrawal syndrome
    Additional description: Alcohol withdrawal syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
    Additional description: Alcoholism
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
    Additional description: Anxiety disorder
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Delirium
    Additional description: Delirium
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    Additional description: Depression
         subjects affected / exposed
    3 / 1395 (0.22%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
    Additional description: Panic attack
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device lead issue
    Additional description: Device lead issue
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
    Additional description: Device occlusion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device power source issue
    Additional description: Device power source issue
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
    Additional description: Lead dislodgement
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
    Additional description: Acute hepatic failure
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Autoimmune hepatitis
    Additional description: Autoimmune hepatitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
    Additional description: Bile duct stone
         subjects affected / exposed
    3 / 1395 (0.22%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
    Additional description: Cholangitis
         subjects affected / exposed
    0 / 1395 (0.00%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
    Additional description: Cholecystitis
         subjects affected / exposed
    7 / 1395 (0.50%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
    Additional description: Cholecystitis acute
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
    Additional description: Cholelithiasis
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
    Additional description: Hepatic cirrhosis
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
    Additional description: Hepatic cyst
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
    Additional description: Hepatitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
    Additional description: Hepatitis toxic
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal vein thrombosis
    Additional description: Portal vein thrombosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiogram
    Additional description: Angiogram
         subjects affected / exposed
    31 / 1395 (2.22%)
    16 / 1394 (1.15%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthroscopy
    Additional description: Arthroscopy
         subjects affected / exposed
    4 / 1395 (0.29%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy bone
    Additional description: Biopsy bone
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy breast
    Additional description: Biopsy breast
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy lung normal
    Additional description: Biopsy lung normal
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
    Additional description: Biopsy prostate
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood thyroid stimulating hormone increased
    Additional description: Blood thyroid stimulating hormone increased
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchoscopy
    Additional description: Bronchoscopy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
    Additional description: C-reactive protein increased
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac monitoring
    Additional description: Cardiac monitoring
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pacemaker evaluation
    Additional description: Cardiac pacemaker evaluation
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac pharmacologic stress test
    Additional description: Cardiac pharmacologic stress test
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test
    Additional description: Cardiac stress test
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular evaluation
    Additional description: Cardiovascular evaluation
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonoscopy
    Additional description: Colonoscopy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diagnostic procedure
    Additional description: Diagnostic procedure
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Echocardiogram
    Additional description: Echocardiogram
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
    Additional description: Electrocardiogram QT prolonged
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gynaecological examination
    Additional description: Gynaecological examination
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
    Additional description: Haemoglobin decreased
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
    Additional description: Hepatic enzyme increased
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysteroscopy
    Additional description: Hysteroscopy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Magnetic resonance imaging
    Additional description: Magnetic resonance imaging
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress echocardiogram
    Additional description: Stress echocardiogram
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
    Additional description: Troponin increased
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour marker increased
    Additional description: Tumour marker increased
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral test negative
    Additional description: Viral test negative
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
    Additional description: Weight decreased
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Alcohol poisoning
    Additional description: Alcohol poisoning
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
    Additional description: Anaemia postoperative
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Animal bite
    Additional description: Animal bite
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
    Additional description: Ankle fracture
         subjects affected / exposed
    6 / 1395 (0.43%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod bite
    Additional description: Arthropod bite
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Buttock injury
    Additional description: Buttock injury
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
    Additional description: Cervical vertebral fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
    Additional description: Clavicle fracture
         subjects affected / exposed
    0 / 1395 (0.00%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
    Additional description: Craniocerebral injury
         subjects affected / exposed
    9 / 1395 (0.65%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Endotracheal intubation complication
    Additional description: Endotracheal intubation complication
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
    Additional description: Facial bones fracture
         subjects affected / exposed
    5 / 1395 (0.36%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
    Additional description: Fall
         subjects affected / exposed
    14 / 1395 (1.00%)
    10 / 1394 (0.72%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
    Additional description: Femur fracture
         subjects affected / exposed
    11 / 1395 (0.79%)
    8 / 1394 (0.57%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Fibula fracture
    Additional description: Fibula fracture
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
    Additional description: Foot fracture
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stoma complication
    Additional description: Gastrointestinal stoma complication
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
    Additional description: Hand fracture
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
    Additional description: Head injury
         subjects affected / exposed
    4 / 1395 (0.29%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
    Additional description: Hip fracture
         subjects affected / exposed
    0 / 1395 (0.00%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Humerus fracture
    Additional description: Humerus fracture
         subjects affected / exposed
    4 / 1395 (0.29%)
    15 / 1394 (1.08%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
    Additional description: Injury
         subjects affected / exposed
    2 / 1395 (0.14%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    Additional description: Joint dislocation
         subjects affected / exposed
    4 / 1395 (0.29%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal injury
    Additional description: Laryngeal injury
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb crushing injury
    Additional description: Limb crushing injury
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
    Additional description: Lower limb fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
    Additional description: Lumbar vertebral fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
    Additional description: Multiple injuries
         subjects affected / exposed
    7 / 1395 (0.50%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Nerve injury
    Additional description: Nerve injury
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
    Additional description: Overdose
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella fracture
    Additional description: Patella fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
    Additional description: Pelvic fracture
         subjects affected / exposed
    5 / 1395 (0.36%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic neck syndrome
    Additional description: Post-traumatic neck syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
    Additional description: Post procedural complication
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
    Additional description: Post procedural haematoma
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
    Additional description: Post procedural haemorrhage
         subjects affected / exposed
    26 / 1395 (1.86%)
    26 / 1394 (1.87%)
         occurrences causally related to treatment / all
    1 / 26
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative thoracic procedure complication
    Additional description: Postoperative thoracic procedure complication
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural intestinal perforation
    Additional description: Procedural intestinal perforation
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
    Additional description: Radius fracture
         subjects affected / exposed
    9 / 1395 (0.65%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
    Additional description: Rib fracture
         subjects affected / exposed
    4 / 1395 (0.29%)
    8 / 1394 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
    Additional description: Road traffic accident
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
    Additional description: Spinal fracture
         subjects affected / exposed
    9 / 1395 (0.65%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
    Additional description: Sternal fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
    Additional description: Subdural haematoma
         subjects affected / exposed
    8 / 1395 (0.57%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tendon rupture
    Additional description: Tendon rupture
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
    Additional description: Thoracic vertebral fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
    Additional description: Tibia fracture
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
    Additional description: Toxicity to various agents
         subjects affected / exposed
    83 / 1395 (5.95%)
    70 / 1394 (5.02%)
         occurrences causally related to treatment / all
    26 / 88
    8 / 78
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Traumatic fracture
    Additional description: Traumatic fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         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
    4 / 1395 (0.29%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haemorrhage
    Additional description: Traumatic haemorrhage
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna fracture
    Additional description: Ulna fracture
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
    Additional description: Upper limb fracture
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine rupture
    Additional description: Uterine rupture
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
    Additional description: Wrist fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
    Additional description: Atrial septal defect
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
    Additional description: Hydrocele
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
    Additional description: Phimosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syringomyelia
    Additional description: Syringomyelia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
    Additional description: Acute coronary syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
    Additional description: Acute myocardial infarction
         subjects affected / exposed
    37 / 1395 (2.65%)
    52 / 1394 (3.73%)
         occurrences causally related to treatment / all
    0 / 46
    0 / 63
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Angina pectoris
    Additional description: Angina pectoris
         subjects affected / exposed
    49 / 1395 (3.51%)
    37 / 1394 (2.65%)
         occurrences causally related to treatment / all
    0 / 58
    0 / 42
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
    Additional description: Angina unstable
         subjects affected / exposed
    17 / 1395 (1.22%)
    15 / 1394 (1.08%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
    Additional description: Aortic valve stenosis
         subjects affected / exposed
    7 / 1395 (0.50%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
    Additional description: Arrhythmia
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
    Additional description: Atrial fibrillation
         subjects affected / exposed
    314 / 1395 (22.51%)
    308 / 1394 (22.09%)
         occurrences causally related to treatment / all
    10 / 526
    6 / 559
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial flutter
    Additional description: Atrial flutter
         subjects affected / exposed
    35 / 1395 (2.51%)
    25 / 1394 (1.79%)
         occurrences causally related to treatment / all
    3 / 46
    1 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
    Additional description: Atrial tachycardia
         subjects affected / exposed
    7 / 1395 (0.50%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
    Additional description: Atrioventricular block
         subjects affected / exposed
    15 / 1395 (1.08%)
    10 / 1394 (0.72%)
         occurrences causally related to treatment / all
    3 / 16
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
    Additional description: Atrioventricular block complete
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
    Additional description: Bradycardia
         subjects affected / exposed
    49 / 1395 (3.51%)
    37 / 1394 (2.65%)
         occurrences causally related to treatment / all
    18 / 52
    9 / 40
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
    Additional description: Bundle branch block left
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
    Additional description: Cardiac arrest
         subjects affected / exposed
    7 / 1395 (0.50%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac failure
    Additional description: Cardiac failure
         subjects affected / exposed
    140 / 1395 (10.04%)
    170 / 1394 (12.20%)
         occurrences causally related to treatment / all
    3 / 222
    0 / 297
         deaths causally related to treatment / all
    0 / 15
    0 / 9
    Cardiac failure congestive
    Additional description: Cardiac failure congestive
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac tamponade
    Additional description: Cardiac tamponade
         subjects affected / exposed
    7 / 1395 (0.50%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
    Additional description: Cardiogenic shock
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiomyopathy
    Additional description: Cardiomyopathy
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiovascular disorder
    Additional description: Cardiovascular disorder
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive cardiomyopathy
    Additional description: Congestive cardiomyopathy
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coronary artery disease
    Additional description: Coronary artery disease
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
    Additional description: Intracardiac thrombus
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
    Additional description: Ischaemic cardiomyopathy
         subjects affected / exposed
    5 / 1395 (0.36%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular failure
    Additional description: Left ventricular failure
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve disease
    Additional description: Mitral valve disease
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
    Additional description: Mitral valve incompetence
         subjects affected / exposed
    3 / 1395 (0.22%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial ischaemia
    Additional description: Myocardial ischaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
    Additional description: Palpitations
         subjects affected / exposed
    5 / 1395 (0.36%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
    Additional description: Pericardial effusion
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
    Additional description: Sinoatrial block
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
    Additional description: Sinus node dysfunction
         subjects affected / exposed
    37 / 1395 (2.65%)
    35 / 1394 (2.51%)
         occurrences causally related to treatment / all
    5 / 41
    1 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
    Additional description: Sinus tachycardia
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
    Additional description: Stress cardiomyopathy
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachyarrhythmia
    Additional description: Supraventricular tachyarrhythmia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
    Additional description: Supraventricular tachycardia
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
    Additional description: Torsade de pointes
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
    Additional description: Ventricular extrasystoles
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
    Additional description: Ventricular fibrillation
         subjects affected / exposed
    4 / 1395 (0.29%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Ventricular tachycardia
    Additional description: Ventricular tachycardia
         subjects affected / exposed
    3 / 1395 (0.22%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
    Additional description: Amnesia
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal ganglia haemorrhage
    Additional description: Basal ganglia haemorrhage
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
    Additional description: Brain injury
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carotid artery stenosis
    Additional description: Carotid artery stenosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
    Additional description: Carpal tunnel syndrome
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         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 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
    Additional description: Cerebral infarction
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebral small vessel ischaemic disease
    Additional description: Cerebral small vessel ischaemic disease
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal fluid leakage
    Additional description: Cerebrospinal fluid leakage
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
    Additional description: Cervicobrachial syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic inflammatory demyelinating polyradiculoneuropathy
    Additional description: Chronic inflammatory demyelinating polyradiculoneuropathy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
    Additional description: Dementia
         subjects affected / exposed
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia with Lewy bodies
    Additional description: Dementia with Lewy bodies
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic hyperosmolar coma
    Additional description: Diabetic hyperosmolar coma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    6 / 1395 (0.43%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal headache
    Additional description: Drug withdrawal headache
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic cerebral infarction
    Additional description: Embolic cerebral infarction
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
    Additional description: Encephalopathy
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
    Additional description: Epilepsy
         subjects affected / exposed
    8 / 1395 (0.57%)
    9 / 1394 (0.65%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Guillain-Barre syndrome
    Additional description: Guillain-Barre syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
    Additional description: Haemorrhage intracranial
         subjects affected / exposed
    0 / 1395 (0.00%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
    Additional description: Haemorrhagic stroke
         subjects affected / exposed
    7 / 1395 (0.50%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Headache
    Additional description: Headache
         subjects affected / exposed
    4 / 1395 (0.29%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
    Additional description: Hydrocephalus
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
    Additional description: Intercostal neuralgia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
    Additional description: Intracranial aneurysm
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
    Additional description: Ischaemic stroke
         subjects affected / exposed
    32 / 1395 (2.29%)
    48 / 1394 (3.44%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 51
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Migraine
    Additional description: Migraine
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis
    Additional description: Multiple sclerosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple system atrophy
    Additional description: Multiple system atrophy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myasthenia gravis
    Additional description: Myasthenia gravis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
    Additional description: Neuralgia
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuritis
    Additional description: Neuritis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurodegenerative disorder
    Additional description: Neurodegenerative disorder
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurological symptom
    Additional description: Neurological symptom
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
    Additional description: Normal pressure hydrocephalus
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuritis
    Additional description: Optic neuritis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
    Additional description: Paraesthesia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    6 / 1395 (0.43%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
    Additional description: Partial seizures
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral nerve lesion
    Additional description: Peripheral nerve lesion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Piriformis syndrome
    Additional description: Piriformis syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
    Additional description: Polyneuropathy
         subjects affected / exposed
    4 / 1395 (0.29%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy alcoholic
    Additional description: Polyneuropathy alcoholic
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
    Additional description: Presyncope
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
    Additional description: Sciatica
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord compression
    Additional description: Spinal cord compression
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal cord ischaemia
    Additional description: Spinal cord ischaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal epidural haematoma
    Additional description: Spinal epidural haematoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Syncope
    Additional description: Syncope
         subjects affected / exposed
    62 / 1395 (4.44%)
    46 / 1394 (3.30%)
         occurrences causally related to treatment / all
    5 / 71
    2 / 57
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
    Additional description: Transient ischaemic attack
         subjects affected / exposed
    25 / 1395 (1.79%)
    25 / 1394 (1.79%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
    Additional description: Tremor
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIIth nerve lesion
    Additional description: VIIIth nerve lesion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve disorder
    Additional description: VIth nerve disorder
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIth nerve paralysis
    Additional description: VIth nerve paralysis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
    Additional description: Agranulocytosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
    Additional description: Anaemia
         subjects affected / exposed
    15 / 1395 (1.08%)
    19 / 1394 (1.36%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia of malignant disease
    Additional description: Anaemia of malignant disease
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
    Additional description: Iron deficiency anaemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
    Additional description: Lymphadenopathy
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
    Additional description: Nephrogenic anaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
    Additional description: Pancytopenia
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    Additional description: Thrombocytopenia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute vestibular syndrome
    Additional description: Acute vestibular syndrome
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
    Additional description: Deafness
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis of external ear canal
    Additional description: Exostosis of external ear canal
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniere's disease
    Additional description: Meniere's disease
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
    Additional description: Vertigo
         subjects affected / exposed
    8 / 1395 (0.57%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
    Additional description: Vertigo positional
         subjects affected / exposed
    5 / 1395 (0.36%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
    Additional description: Vestibular disorder
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Age-related macular degeneration
    Additional description: Age-related macular degeneration
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle closure glaucoma
    Additional description: Angle closure glaucoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Entropion
    Additional description: Entropion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
    Additional description: Eye haemorrhage
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
    Additional description: Glaucoma
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery embolism
    Additional description: Retinal artery embolism
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
    Additional description: Retinal detachment
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vein occlusion
    Additional description: Retinal vein occlusion
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
    Additional description: Visual impairment
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
    Additional description: Abdominal discomfort
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
    Additional description: Abdominal hernia
         subjects affected / exposed
    2 / 1395 (0.14%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
    Additional description: Abdominal pain
         subjects affected / exposed
    21 / 1395 (1.51%)
    12 / 1394 (0.86%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
    Additional description: Abdominal pain upper
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute abdomen
    Additional description: Acute abdomen
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cheilitis
    Additional description: Cheilitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
    Additional description: Colitis ischaemic
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    Additional description: Constipation
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
    Additional description: Crohn's disease
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic hernia
    Additional description: Diaphragmatic hernia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    Additional description: Diarrhoea
         subjects affected / exposed
    3 / 1395 (0.22%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
    Additional description: Diverticulum
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenogastric reflux
    Additional description: Duodenogastric reflux
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
    Additional description: Dysphagia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
    Additional description: Enteritis
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
    Additional description: Enterocolitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
    Additional description: Gastric haemorrhage
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    12 / 1395 (0.86%)
    10 / 1394 (0.72%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
    Additional description: Gastrointestinal haemorrhage
         subjects affected / exposed
    40 / 1395 (2.87%)
    26 / 1394 (1.87%)
         occurrences causally related to treatment / all
    0 / 46
    0 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastrointestinal ischaemia
    Additional description: Gastrointestinal ischaemia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrooesophageal reflux disease
    Additional description: Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoperitoneum
    Additional description: Haemoperitoneum
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
    Additional description: Haemorrhoids
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
    Additional description: Hiatus hernia
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
    Additional description: Ileus
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Inguinal hernia
    Additional description: Inguinal hernia
         subjects affected / exposed
    4 / 1395 (0.29%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia strangulated
    Additional description: Inguinal hernia strangulated
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
    Additional description: Intestinal fistula
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
    Additional description: Intestinal obstruction
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
    Additional description: Large intestine perforation
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
    Additional description: Large intestine polyp
         subjects affected / exposed
    1 / 1395 (0.07%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
    Additional description: Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
    Additional description: Melaena
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric arterial occlusion
    Additional description: Mesenteric arterial occlusion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mesenteric artery embolism
    Additional description: Mesenteric artery embolism
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Mesenteric vein thrombosis
    Additional description: Mesenteric vein thrombosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
    Additional description: Oesophageal stenosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
    Additional description: Oesophagitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
    Additional description: Pancreatitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
    Additional description: Pancreatitis acute
         subjects affected / exposed
    4 / 1395 (0.29%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
    Additional description: Pancreatitis chronic
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
    Additional description: Peptic ulcer
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
    Additional description: Rectal haemorrhage
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary gland enlargement
    Additional description: Salivary gland enlargement
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Short-bowel syndrome
    Additional description: Short-bowel syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
    Additional description: Subileus
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    2 / 1395 (0.14%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
    Additional description: Volvulus
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Decubitus ulcer
    Additional description: Decubitus ulcer
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
    Additional description: Dermatitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
    Additional description: Diabetic foot
         subjects affected / exposed
    2 / 1395 (0.14%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
    Additional description: Eczema
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
    Additional description: Erythema
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma annulare
    Additional description: Granuloma annulare
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
    Additional description: Pruritus
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
    Additional description: Psoriasis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin lesion
    Additional description: Skin lesion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
    Additional description: Urticaria
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
    Additional description: Acute kidney injury
         subjects affected / exposed
    6 / 1395 (0.43%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
    Additional description: Calculus bladder
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
    Additional description: Calculus urinary
         subjects affected / exposed
    5 / 1395 (0.36%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
    Additional description: Chronic kidney disease
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
    Additional description: Cystitis haemorrhagic
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
    Additional description: Haematuria
         subjects affected / exposed
    0 / 1395 (0.00%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
    Additional description: Hydronephrosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incontinence
    Additional description: Incontinence
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
    Additional description: Nephrolithiasis
         subjects affected / exposed
    3 / 1395 (0.22%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
    Additional description: Nephrotic syndrome
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
    Additional description: Renal artery stenosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
    Additional description: Renal colic
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
    Additional description: Renal failure
         subjects affected / exposed
    21 / 1395 (1.51%)
    21 / 1394 (1.51%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 23
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Renal haemorrhage
    Additional description: Renal haemorrhage
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
    Additional description: Stress urinary incontinence
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
    Additional description: Urethral obstruction
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
    Additional description: Urinary incontinence
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
    Additional description: Urinary retention
         subjects affected / exposed
    5 / 1395 (0.36%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urogenital haemorrhage
    Additional description: Urogenital haemorrhage
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
    Additional description: Adrenal insufficiency
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenocortical insufficiency acute
    Additional description: Adrenocortical insufficiency acute
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
    Additional description: Goitre
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperadrenocorticism
    Additional description: Hyperadrenocorticism
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
    Additional description: Hyperthyroidism
         subjects affected / exposed
    6 / 1395 (0.43%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    3 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
    Additional description: Hypothyroidism
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate antidiuretic hormone secretion
    Additional description: Inappropriate antidiuretic hormone secretion
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary-dependent Cushing's syndrome
    Additional description: Pituitary-dependent Cushing's syndrome
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
    Additional description: Arthralgia
         subjects affected / exposed
    6 / 1395 (0.43%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
    Additional description: Arthritis
         subjects affected / exposed
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
    Additional description: Back pain
         subjects affected / exposed
    24 / 1395 (1.72%)
    16 / 1394 (1.15%)
         occurrences causally related to treatment / all
    0 / 31
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
    Additional description: Bursitis
         subjects affected / exposed
    2 / 1395 (0.14%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
    Additional description: Cervical spinal stenosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's contracture
    Additional description: Dupuytren's contracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exostosis
    Additional description: Exostosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
    Additional description: Fistula
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
    Additional description: Foot deformity
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin pain
    Additional description: Groin pain
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
    Additional description: Intervertebral disc protrusion
         subjects affected / exposed
    5 / 1395 (0.36%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
    Additional description: Lumbar spinal stenosis
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
    Additional description: Musculoskeletal chest pain
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
    Additional description: Musculoskeletal pain
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
    Additional description: Myalgia
         subjects affected / exposed
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    Additional description: Osteoarthritis
         subjects affected / exposed
    7 / 1395 (0.50%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
    Additional description: Osteonecrosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
    Additional description: Osteoporotic fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
    Additional description: Pain in extremity
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
    Additional description: Pathological fracture
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
    Additional description: Polyarthritis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma
    Additional description: Scleroderma
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal stenosis
    Additional description: Spinal stenosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitis
    Additional description: Spondylitis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
    Additional description: Spondylolisthesis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic lupus erythematosus
    Additional description: Systemic lupus erythematosus
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
    Additional description: Abdominal abscess
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
    Additional description: Abscess
         subjects affected / exposed
    3 / 1395 (0.22%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess bacterial
    Additional description: Abscess bacterial
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
    Additional description: Anal abscess
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    3 / 1395 (0.22%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
    Additional description: Arthritis bacterial
         subjects affected / exposed
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
    Additional description: Bacterial infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac infection
    Additional description: Cardiac infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    3 / 1395 (0.22%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
    Additional description: Chronic sinusitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    0 / 1395 (0.00%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Creutzfeldt-Jakob disease
    Additional description: Creutzfeldt-Jakob disease
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Device related infection
    Additional description: Device related infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
    Additional description: Diverticulitis
         subjects affected / exposed
    15 / 1395 (1.08%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear infection
    Additional description: Ear infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    2 / 1395 (0.14%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
    Additional description: Encephalitis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
    Additional description: Endocarditis
         subjects affected / exposed
    4 / 1395 (0.29%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epididymitis
    Additional description: Epididymitis
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
    Additional description: Erysipelas
         subjects affected / exposed
    15 / 1395 (1.08%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastroenteritis
    Additional description: Gastroenteritis
         subjects affected / exposed
    9 / 1395 (0.65%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
    Additional description: Gastrointestinal infection
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
    Additional description: Groin abscess
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
    Additional description: Herpes zoster
         subjects affected / exposed
    2 / 1395 (0.14%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
    Additional description: Infection
         subjects affected / exposed
    14 / 1395 (1.00%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intervertebral discitis
    Additional description: Intervertebral discitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
    Additional description: Localised infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
    Additional description: Mediastinitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle abscess
    Additional description: Muscle abscess
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
    Additional description: Oesophageal candidiasis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic herpes zoster
    Additional description: Ophthalmic herpes zoster
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
    Additional description: Osteomyelitis
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
    Additional description: Otitis media
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
    Additional description: Paronychia
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
    Additional description: Peritonitis
         subjects affected / exposed
    3 / 1395 (0.22%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    Additional description: Pharyngitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    Additional description: Pneumonia
         subjects affected / exposed
    69 / 1395 (4.95%)
    81 / 1394 (5.81%)
         occurrences causally related to treatment / all
    1 / 90
    1 / 106
         deaths causally related to treatment / all
    0 / 7
    1 / 9
    Post procedural infection
    Additional description: Post procedural infection
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
    Additional description: Pyelonephritis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
    Additional description: Pyelonephritis acute
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
    Additional description: Respiratory tract infection
         subjects affected / exposed
    9 / 1395 (0.65%)
    13 / 1394 (0.93%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rotavirus infection
    Additional description: Rotavirus infection
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         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
    13 / 1395 (0.93%)
    17 / 1394 (1.22%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 17
         deaths causally related to treatment / all
    0 / 7
    0 / 7
    Septic encephalopathy
    Additional description: Septic encephalopathy
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
    Additional description: Septic shock
         subjects affected / exposed
    2 / 1395 (0.14%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Skin bacterial infection
    Additional description: Skin bacterial infection
         subjects affected / exposed
    6 / 1395 (0.43%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal sepsis
    Additional description: Staphylococcal sepsis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tick-borne viral encephalitis
    Additional description: Tick-borne viral encephalitis
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
    Additional description: Tooth abscess
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
    Additional description: Tuberculosis
         subjects affected / exposed
    0 / 1395 (0.00%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    Additional description: Urinary tract infection
         subjects affected / exposed
    27 / 1395 (1.94%)
    19 / 1394 (1.36%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
    Additional description: Urosepsis
         subjects affected / exposed
    6 / 1395 (0.43%)
    9 / 1394 (0.65%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Viral infection
    Additional description: Viral infection
         subjects affected / exposed
    1 / 1395 (0.07%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
    Additional description: Wound infection
         subjects affected / exposed
    5 / 1395 (0.36%)
    11 / 1394 (0.79%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    Additional description: Dehydration
         subjects affected / exposed
    4 / 1395 (0.29%)
    4 / 1394 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
    Additional description: Diabetes mellitus
         subjects affected / exposed
    0 / 1395 (0.00%)
    7 / 1394 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyslipidaemia
    Additional description: Dyslipidaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
    Additional description: Electrolyte imbalance
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
    Additional description: Gout
         subjects affected / exposed
    2 / 1395 (0.14%)
    5 / 1394 (0.36%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
    Additional description: Hyperglycaemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    3 / 1394 (0.22%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
    Additional description: Hyperkalaemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    0 / 1394 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
    Additional description: Hypoglycaemia
         subjects affected / exposed
    3 / 1395 (0.22%)
    2 / 1394 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
    Additional description: Hypokalaemia
         subjects affected / exposed
    1 / 1395 (0.07%)
    1 / 1394 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
    Additional description: Hyponatraemia
         subjects affected / exposed
    2 / 1395 (0.14%)
    6 / 1394 (0.43%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
    Additional description: Metabolic acidosis
         subjects affected / exposed
    1 / 1395 (0.07%)
    0 / 1394 (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
    		 Early rhythm control Usual care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1395 (0.00%)
    0 / 1394 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Dec 2010
    Essential changes in inclusion criteria
    09 Dec 2011
    essential changes and administrative changes
    14 May 2015
    essential changes and further administrative changes

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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