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    Clinical Trial Results:
    UK Multicentre Open-label Randomised Controlled Trial Of IV Iron Therapy In Incident Haemodialysis Patients

    Summary
    EudraCT number
    2013-002267-25
    Trial protocol
    GB  
    Global end of trial date
    06 Jun 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    04 Aug 2019
    First version publication date
    04 Aug 2019
    Other versions
    Summary report(s)
    Final Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    PIVOTAL
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    King's College Hospital NHS Foundation Trust
    Sponsor organisation address
    Denmark Hill, London, United Kingdom, SE5 9RS
    Public contact
    Professor Iain Macdougall, King's College Hospital NHS Foundation Trust, +44 02032996233, iain.macdougall@nhs.net
    Scientific contact
    Professor Iain Macdougall, King's College Hospital NHS Foundation Trust, +44 02032996233, iain.macdougall@nhs.net
    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
    06 Jun 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients.
    Protection of trial subjects
    During the period between informed consent and randomisation, if there is a strong clinical indication that a patient requires iron, then iron may be administered (this is not considered to be a protocol breach).
    Background therapy
    Patients established on a chronic haemodialysis programme for end-stage renal failure
    Evidence for comparator
    To compare the effect of a proactive high-dose, with a reactive low-dose, IV iron regimen on all-cause mortality and the incidence of non-fatal cardiovascular endpoints in haemodialysis patients
    Actual start date of recruitment
    01 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 2141
    Worldwide total number of subjects
    2141
    EEA total number of subjects
    2141
    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)
    865
    From 65 to 84 years
    1024
    85 years and over
    252

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from multiple clinical centres across the UK between 2013 and 2018

    Pre-assignment
    Screening details
    Age >18 years - Patients established on a chronic haemodialysis programme for end-stage renal failure - Clinically stable (Investigator’s judgement) - 0–12 months since commencing haemodialysis

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Proactive IV iron arm
    Arm description
    IV iron 400mg/month Total study period approximately 4 years (event-driven) – projected treatment duration per patient > 2 years
    Arm type
    Experimental

    Investigational medicinal product name
    Venofer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV iron 400mg/month by Intravenous Infustion

    Arm title
    Reactive IV iron arm
    Arm description
    IV iron sucrose 100–200mg / month if becomes “iron deficien
    Arm type
    Active comparator

    Investigational medicinal product name
    Venofer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    IV iron sucrose 100–200mg / month if becomes “iron deficien

    Number of subjects in period 1
    Proactive IV iron arm Reactive IV iron arm
    Started
    1093
    1048
    Completed
    488
    407
    Not completed
    605
    641
         Protocol deviation
    13
    10
         Home dialysis
    45
    36
         Moved to peritoneal dialysis
    13
    17
         Transplant
    184
    187
         Adverse event, serious fatal
    246
    269
         Consent withdrawn by subject
    42
    44
         Lost to follow-up
    62
    78

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Proactive IV iron arm
    Reporting group description
    IV iron 400mg/month Total study period approximately 4 years (event-driven) – projected treatment duration per patient > 2 years

    Reporting group title
    Reactive IV iron arm
    Reporting group description
    IV iron sucrose 100–200mg / month if becomes “iron deficien

    Primary: Time to first event

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    End point title
    Time to first event [1]
    End point description
    Time to first event: all-cause death or a composite of non-fatal cardiovascular events (myocardial infarction, stroke, and hospitalisation for heart failure) adjudicated by a blinded Endpoint Adjudication Committee.
    End point type
    Primary
    End point timeframe
    not applicable
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Please see attached publication and appendix
    End point values
    Proactive IV iron arm Reactive IV iron arm
    Number of subjects analysed
    1080
    1038
    Units: whole
    1080
    1038
    Attachments
    Results additional data
    No statistical analyses for this end point

    Secondary: Secondary Efficacy Endpoints

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    End point title
    Secondary Efficacy Endpoints
    End point description
    Incidence of all-cause death and a composite of myocardial infarction, stroke, and hospitalisation for heart failure as recurrent events. - Time to (and incidence of) all-cause death - Time to (and incidence of) first composite cardiovascular event - Time to (and incidence of) first myocardial infarction - Time to (and incidence of) first stroke - Time to (and incidence of) first hospitalisation for heart failure - Transfusion requirements - EQ-5D QOL and KDQOL - ESA dose requirements
    End point type
    Secondary
    End point timeframe
    0 to 18 months (event driven)
    End point values
    Proactive IV iron arm Reactive IV iron arm
    Number of subjects analysed
    1080
    1038
    Units: whole
    1080
    1038
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse events were recorded from baseline/randomisation until the end of study for each patient.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Proactive IV Iron
    Reporting group description
    -

    Reporting group title
    Reactive IV Iron
    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: Adverse events or reactions listed in the SmPC were not reported, with the exception of immediate hypersensitivity-like reactions to IV iron. Common non-life-threatening symptoms such as constipation, diarrhoea, headache, etc. do not need to be reported. Only serious adverse events and episodes of infection and vascular access thrombosis will be recorded. No other non-serious adverse events will be recorded.
    Serious adverse events
    Proactive IV Iron Reactive IV Iron
    Total subjects affected by serious adverse events
         subjects affected / exposed
    709 / 1093 (64.87%)
    671 / 1048 (64.03%)
         number of deaths (all causes)
    246
    269
         number of deaths resulting from adverse events
    246
    269
    Injury, poisoning and procedural complications
    ACCIDENTAL OVERDOSE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANEURYSM ARTERIOVENOUS FISTULA
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS FISTULA OCCLUSION
         subjects affected / exposed
    34 / 1093 (3.11%)
    33 / 1048 (3.15%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 36
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACCIDENT
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ARTERIOVENOUS FISTULA SITE COMPLICATION
         subjects affected / exposed
    24 / 1093 (2.20%)
    20 / 1048 (1.91%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ARTERIOVENOUS FISTULA SITE HAEMORRHAGE
         subjects affected / exposed
    12 / 1093 (1.10%)
    12 / 1048 (1.15%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ARTERIOVENOUS FISTULA THROMBOSIS
         subjects affected / exposed
    43 / 1093 (3.93%)
    27 / 1048 (2.58%)
         occurrences causally related to treatment / all
    0 / 52
    0 / 28
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ARTERIOVENOUS GRAFT SITE HAEMATOMA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CERVICAL VERTEBRAL FRACTURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLAVICLE FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMPLICATIONS OF TRANSPLANT SURGERY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CONTUSION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIALYSIS RELATED COMPLICATION
         subjects affected / exposed
    7 / 1093 (0.64%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    FACE INJURY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FALL
         subjects affected / exposed
    33 / 1093 (3.02%)
    55 / 1048 (5.25%)
         occurrences causally related to treatment / all
    0 / 39
    0 / 59
         deaths causally related to treatment / all
    0 / 1
    0 / 13
    FEMORAL NECK FRACTURE
         subjects affected / exposed
    13 / 1093 (1.19%)
    23 / 1048 (2.19%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 24
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    FEMUR FRACTURE
         subjects affected / exposed
    2 / 1093 (0.18%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    FIBULA FRACTURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    FOREIGN BODY
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    GASTROINTESTINAL STOMA COMPLICATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT COMPLICATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT HAEMORRHAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT THROMBOSIS
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATURIA TRAUMATIC
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMODIALYSIS COMPLICATION
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HAEMODIALYSIS-INDUCED SYMPTOM
         subjects affected / exposed
    4 / 1093 (0.37%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAND FRACTURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEAD INJURY
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEPATIC HAEMATOMA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HIP FRACTURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HUMERUS FRACTURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    IATROGENIC INJURY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA, OBSTRUCTIVE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INJURY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    JOINT DISLOCATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT INJURY
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACERATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIMB INJURY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER LIMB FRACTURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MULTIPLE FRACTURES
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCLE INJURY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVERDOSE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PATELLA FRACTURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PELVIC FRACTURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPROSTHETIC FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONEAL DIALYSIS COMPLICATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST GASTRIC SURGERY SYNDROME
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL COMPLICATION
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL DIARRHOEA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL HAEMATOMA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL MYOCARDIAL INFARCTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    POST PROCEDURAL SWELLING
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POSTOPERATIVE ILEUS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    POSTOPERATIVE WOUND COMPLICATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL COMPLICATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL HAEMORRHAGE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL HYPERTENSION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL HYPOTENSION
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    PROCEDURAL PAIN
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PROCEDURAL VOMITING
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PUBIS FRACTURE
         subjects affected / exposed
    2 / 1093 (0.18%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RADIUS FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL GRAFT LOSS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SHUNT OCCLUSION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOFT TISSUE INJURY
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL FRACTURE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    SUBDURAL HAEMATOMA
         subjects affected / exposed
    4 / 1093 (0.37%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    SUBDURAL HAEMORRHAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    TIBIA FRACTURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOXICITY TO VARIOUS AGENTS
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRAUMATIC HAEMATOMA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER LIMB FRACTURE
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR ACCESS COMPLICATION
         subjects affected / exposed
    20 / 1093 (1.83%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    VASCULAR GRAFT COMPLICATION
         subjects affected / exposed
    3 / 1093 (0.27%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR GRAFT OCCLUSION
         subjects affected / exposed
    8 / 1093 (0.73%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR GRAFT THROMBOSIS
         subjects affected / exposed
    14 / 1093 (1.28%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR PSEUDOANEURYSM
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND HAEMATOMA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENOUS INJURY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    ANTICOAGULATION DRUG LEVEL ABOVE THERAPEUTIC
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERIOGRAM
         subjects affected / exposed
    0 / 1093 (0.00%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BIOPSY LYMPH GLAND
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD CULTURE POSITIVE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD GLUCOSE ABNORMAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD GLUCOSE FLUCTUATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD GLUCOSE INCREASED
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD PHOSPHORUS DECREASED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD POTASSIUM INCREASED
         subjects affected / exposed
    4 / 1093 (0.37%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLOOD PRESSURE INCREASED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC OUTPUT DECREASED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC PACEMAKER EVALUATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM TEST POSITIVE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COLONOSCOPY
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMA SCALE ABNORMAL
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-REACTIVE PROTEIN ABNORMAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-REACTIVE PROTEIN INCREASED
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG LEVEL ABOVE THERAPEUTIC
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECHOCARDIOGRAM ABNORMAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ELECTROCARDIOGRAM ABNORMAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FISTULOGRAM
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DECREASED HAEMOGLOBIN
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEART RATE IRREGULAR
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFLAMMATORY MARKER INCREASED
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERNATIONAL NORMALISED RATIO ABNORMAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTERNATIONAL NORMALISED RATIO INCREASED
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LISTERIA TEST POSITIVE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER FUNCTION TEST ABNORMAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEDIASTINOSCOPY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY FUNCTION TEST DECREASED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SIGMOIDOSCOPY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TROPONIN INCREASED
         subjects affected / exposed
    1 / 1093 (0.09%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCREASED T TROPONIN
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINE OUTPUT DECREASED
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WEIGHT DECREASED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac disorders
    Myocardial infarction
         subjects affected / exposed
    16 / 1093 (1.46%)
    9 / 1048 (0.86%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 9
         deaths causally related to treatment / all
    0 / 16
    0 / 9
    Acute coronary syndrome
         subjects affected / exposed
    5 / 1093 (0.46%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    42 / 1093 (3.84%)
    50 / 1048 (4.77%)
         occurrences causally related to treatment / all
    0 / 46
    0 / 59
         deaths causally related to treatment / all
    0 / 6
    0 / 5
    Angina pectoris
         subjects affected / exposed
    9 / 1093 (0.82%)
    12 / 1048 (1.15%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unstable Angina
         subjects affected / exposed
    3 / 1093 (0.27%)
    9 / 1048 (0.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    13 / 1093 (1.19%)
    21 / 1048 (2.00%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 26
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Bradycardia
         subjects affected / exposed
    8 / 1093 (0.73%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac arrest
         subjects affected / exposed
    21 / 1093 (1.92%)
    26 / 1048 (2.48%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 26
         deaths causally related to treatment / all
    0 / 17
    0 / 19
    Cardiac disorder
         subjects affected / exposed
    6 / 1093 (0.55%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure
         subjects affected / exposed
    7 / 1093 (0.64%)
    9 / 1048 (0.86%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Acute Cardiac failure
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Congestive Cardiac failure
         subjects affected / exposed
    6 / 1093 (0.55%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Cardio-respiratory arrest
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    4 / 1093 (0.37%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Atrial flutter
         subjects affected / exposed
    2 / 1093 (0.18%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complete Atrioventricular block
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cardiac tamponade
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    6 / 1093 (0.55%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 2
    0 / 5
    Cardiogenic shock
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiomegaly
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intracardiac mass
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Left ventricular failure
         subjects affected / exposed
    0 / 1093 (0.00%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mitral valve disease
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    5 / 1093 (0.46%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Myocarditis
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    5 / 1093 (0.46%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal arrhythmia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    4 / 1093 (0.37%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Supraventricular tachycardia
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachycardia
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Tracheo-oesophageal fistula
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    8 / 1093 (0.73%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphadenectomy
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic anaemia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    AMNESIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APHASIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BALANCE DISORDER
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BALLISMUS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BASAL GANGLIA STROKE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRAIN INJURY
         subjects affected / exposed
    3 / 1093 (0.27%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    CAROTID ARTERY STENOSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CENTRAL NERVOUS SYSTEM LESION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBRAL HAEMORRHAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    CEREBRAL INFARCTION
         subjects affected / exposed
    4 / 1093 (0.37%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    CEREBRAL ISCHAEMIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CEREBROVASCULAR ACCIDENT
         subjects affected / exposed
    12 / 1093 (1.10%)
    16 / 1048 (1.53%)
         occurrences causally related to treatment / all
    0 / 45
    0 / 18
         deaths causally related to treatment / all
    0 / 8
    0 / 5
    CEREBROVASCULAR DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COMA URAEMIC
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CONSCIOUSNESS FLUCTUATING
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    CONVULSION
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEPRESSED LEVEL OF CONSCIOUSNESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIZZINESS
         subjects affected / exposed
    8 / 1093 (0.73%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSARTHRIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSKINESIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMBOLIC CEREBRAL INFARCTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS AUTOIMMUNE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALOPATHY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EPILEPSY
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAND MAL CONVULSION
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GUILLAIN-BARRE SYNDROME
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE INTRACRANIAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    HAEMORRHAGIC CEREBRAL INFARCTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    HAEMORRHAGIC STROKE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HEADACHE
         subjects affected / exposed
    6 / 1093 (0.55%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HEMIPARESIS
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HEPATIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIC SEIZURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSIVE ENCEPHALOPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOAESTHESIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIC SEIZURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INTRAVENTRICULAR HAEMORRHAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LACUNAR INFARCTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LETHARGY
         subjects affected / exposed
    5 / 1093 (0.46%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    LOSS OF CONSCIOUSNESS
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MEMORY IMPAIRMENT
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MERALGIA PARAESTHETICA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MIGRAINE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MOVEMENT DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    MYOCLONUS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYXOEDEMA COMA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NERVOUS SYSTEM DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    NEUROLOGICAL SYMPTOM
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROPATHY PERIPHERAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERONEAL NERVE PALSY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRESYNCOPE
         subjects affected / exposed
    7 / 1093 (0.64%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEIZURE LIKE PHENOMENA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SENSORY LOSS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SOMNOLENCE
         subjects affected / exposed
    0 / 1093 (0.00%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPEECH DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPINAL CORD COMPRESSION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYNCOPE
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TRANSIENT ISCHAEMIC ATTACK
         subjects affected / exposed
    11 / 1093 (1.01%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TREMOR
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UNRESPONSIVE TO STIMULI
         subjects affected / exposed
    7 / 1093 (0.64%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    VASCULAR DEMENTIA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIITH NERVE PARALYSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis fugax
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye pain
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal vascular occlusion
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 1093 (0.09%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain
         subjects affected / exposed
    23 / 1093 (2.10%)
    14 / 1048 (1.34%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 15
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Abdominal distension
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 1093 (0.00%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bowel movement irregularity
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac disease
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    colonic stenosis
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    6 / 1093 (0.55%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    11 / 1093 (1.01%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer perforation
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    faecal incontinence
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric antral vascular ectasia
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 1093 (0.27%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 1093 (0.27%)
    9 / 1048 (0.86%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal hypermotility
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal angiodysplasia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    gastrooesophagitis
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    5 / 1093 (0.46%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ileitis
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    6 / 1093 (0.55%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal fistula
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    7 / 1093 (0.64%)
    8 / 1048 (0.76%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Intestinal obstruction
         subjects affected / exposed
    3 / 1093 (0.27%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal perforation
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Large intestine perforation
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malabsorption
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    7 / 1093 (0.64%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal rupture
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic cyst
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatic mass
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis chronic
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Proctitis
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    7 / 1093 (0.64%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Retching
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal fibrosis
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small intestinal obstruction
         subjects affected / exposed
    6 / 1093 (0.55%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Steatorrhoea
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 1093 (0.27%)
    10 / 1048 (0.95%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Umbilical hernia, obstructive
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    26 / 1093 (2.38%)
    18 / 1048 (1.72%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 20
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Renal and urinary disorders
    AZOTAEMIA
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLADDER OUTLET OBSTRUCTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DYSURIA
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATURIA
         subjects affected / exposed
    10 / 1093 (0.91%)
    10 / 1048 (0.95%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MICTURITION URGENCY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROLITHIASIS
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHROTIC SYNDROME
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    OBSTRUCTIVE UROPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL COLIC
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CYST HAEMORRHAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL FAILURE
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    ACUTE RENAL FAILURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHRONIC RENAL FAILURE
         subjects affected / exposed
    8 / 1093 (0.73%)
    27 / 1048 (2.58%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 27
         deaths causally related to treatment / all
    0 / 7
    0 / 21
    RENAL IMPAIRMENT
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    RENAL MASS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL PAIN
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY RETENTION
         subjects affected / exposed
    4 / 1093 (0.37%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT OBSTRUCTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PRIAPISM
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TESTICULAR PAIN
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    COLD SWEAT
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DECUBITUS ULCER
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC FOOT
         subjects affected / exposed
    7 / 1093 (0.64%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DIABETIC ULCER
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRY GANGRENE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERHIDROSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RASH MACULO-PAPULAR
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN NECROSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN REACTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN SWELLING
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SKIN ULCER
         subjects affected / exposed
    11 / 1093 (1.01%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHROPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACK PAIN
         subjects affected / exposed
    3 / 1093 (0.27%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BURSITIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    COCCYDYNIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COSTOCHONDRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FLANK PAIN
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FRACTURE NONUNION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GROIN PAIN
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMARTHROSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    JOINT SWELLING
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MOBILITY DECREASED
         subjects affected / exposed
    4 / 1093 (0.37%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    MUSCLE TWITCHING
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULAR WEAKNESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    MUSCULOSKELETAL CHEST PAIN
         subjects affected / exposed
    6 / 1093 (0.55%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL PAIN
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MUSCULOSKELETAL STIFFNESS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MYOPATHY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NECK PAIN
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUROPATHIC ARTHROPATHY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOARTHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEONECROSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PAIN IN EXTREMITY
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POLYMYALGIA RHEUMATICA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHEUMATOID ARTHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SPINAL OSTEOARTHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SYSTEMIC LUPUS ERYTHEMATOSUS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism tertiary
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    FLUID OVERLOAD
         subjects affected / exposed
    41 / 1093 (3.75%)
    63 / 1048 (6.01%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 79
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    GOUT
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERCALCAEMIA
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERGLYCAEMIA
         subjects affected / exposed
    9 / 1093 (0.82%)
    9 / 1048 (0.86%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERKALAEMIA
         subjects affected / exposed
    29 / 1093 (2.65%)
    28 / 1048 (2.67%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 36
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    HYPOCALCAEMIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOGLYCAEMIA
         subjects affected / exposed
    10 / 1093 (0.91%)
    20 / 1048 (1.91%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPONATRAEMIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOVOLAEMIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALNUTRITION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METABOLIC ACIDOSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    TYPE 1 DIABETES MELLITUS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ACIDOSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CACHEXIA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CALCIPHYLAXIS
         subjects affected / exposed
    3 / 1093 (0.27%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DECREASED APPETITE
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEHYDRATION
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETES MELLITUS
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    INADEQUATE CONTROL DIABETES MELLITUS
         subjects affected / exposed
    1 / 1093 (0.09%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIABETIC KETOACIDOSIS
         subjects affected / exposed
    9 / 1093 (0.82%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    ELECTROLYTE IMBALANCE
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    ABDOMINAL SEPSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ABSCESS LIMB
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANAL ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    APPENDICITIS PERFORATED
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS FISTULA SITE INFECTION
         subjects affected / exposed
    8 / 1093 (0.73%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS GRAFT SITE INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS BACTERIAL
         subjects affected / exposed
    4 / 1093 (0.37%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTHRITIS INFECTIVE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    4 / 1093 (0.37%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BACTERIAL SEPSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    BILIARY SEPSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHIOLITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHITIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRONCHOPNEUMONIA
         subjects affected / exposed
    2 / 1093 (0.18%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    CAMPYLOBACTER GASTROENTERITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAMPYLOBACTER INFECTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CAMPYLOBACTER SEPSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC VALVE VEGETATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    CATHETER SITE INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CELLULITIS
         subjects affected / exposed
    18 / 1093 (1.65%)
    24 / 1048 (2.29%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    CELLULITIS GANGRENOUS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (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 INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIAL INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CLOSTRIDIUM DIFFICILE COLITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CYSTITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED INFECTION
         subjects affected / exposed
    23 / 1093 (2.10%)
    20 / 1048 (1.91%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEVICE RELATED SEPSIS
         subjects affected / exposed
    25 / 1093 (2.29%)
    15 / 1048 (1.43%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 18
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    DIABETIC FOOT INFECTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIVERTICULITIS
         subjects affected / exposed
    3 / 1093 (0.27%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIARRHOEA INFECTIOUS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMPHYSEMATOUS PYELONEPHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMPYEMA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENCEPHALITIS VIRAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ENDOCARDITIS1
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ENTEROBACTER SEPSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOCCAL INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ENTEROCOCCAL SEPSIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ESCHERICHIA BACTERAEMIA
         subjects affected / exposed
    6 / 1093 (0.55%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ESCHERICHIA URINARY TRACT INFECTION
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GALLBLADDER ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GANGRENE
         subjects affected / exposed
    10 / 1093 (0.91%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 3
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    GASTROENTERITIS
         subjects affected / exposed
    11 / 1093 (1.01%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROENTERITIS VIRAL
         subjects affected / exposed
    4 / 1093 (0.37%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GRAFT INFECTION
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GROIN ABSCESS
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1N1 INFLUENZA
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMATOMA INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED SKIN ULCER
         subjects affected / exposed
    6 / 1093 (0.55%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTION
         subjects affected / exposed
    11 / 1093 (1.01%)
    8 / 1048 (0.76%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
         subjects affected / exposed
    4 / 1093 (0.37%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    INFLUENZA
         subjects affected / exposed
    8 / 1093 (0.73%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    INTERVERTEBRAL DISCITIS
         subjects affected / exposed
    4 / 1093 (0.37%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    KLEBSIELLA SEPSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIVER ABSCESS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOBAR PNEUMONIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    LOCALISED INFECTION
         subjects affected / exposed
    10 / 1093 (0.91%)
    12 / 1048 (1.15%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    77 / 1093 (7.04%)
    94 / 1048 (8.97%)
         occurrences causally related to treatment / all
    0 / 92
    0 / 113
         deaths causally related to treatment / all
    0 / 4
    0 / 11
    INJECTION SITE INFECTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTIVE EXACERBATION OF BRONCHIECTASIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    INFECTIVE ANEURYSM
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTIOUS PLEURAL EFFUSION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INFECTED FISTULA
         subjects affected / exposed
    4 / 1093 (0.37%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERPES ZOSTER
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LUNG INFECTION PSEUDOMONAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    METAPNEUMOVIRUS INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEUTROPENIC SEPSIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OESOPHAGEAL CANDIDIASIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORAL CANDIDIASIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OSTEOMYELITIS
         subjects affected / exposed
    8 / 1093 (0.73%)
    17 / 1048 (1.62%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    OTITIS EXTERNA
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    PAROTITIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIHEPATIC ABSCESS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERITONITIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PILONIDAL CYST
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOCOCCAL SEPSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMOCYSTIS JIROVECI PNEUMONIA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA
         subjects affected / exposed
    72 / 1093 (6.59%)
    70 / 1048 (6.68%)
         occurrences causally related to treatment / all
    0 / 83
    0 / 85
         deaths causally related to treatment / all
    0 / 13
    0 / 9
    PNEUMONIA BACTERIAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA INFLUENZAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA KLEBSIELLA
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PNEUMONIA VIRAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL INFECTION
         subjects affected / exposed
    3 / 1093 (0.27%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL PNEUMONIA
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POST PROCEDURAL SEPSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    POSTOPERATIVE WOUND INFECTION
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    PSEUDOMEMBRANOUS COLITIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PSOAS ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PULMONARY SEPSIS
         subjects affected / exposed
    8 / 1093 (0.73%)
    10 / 1048 (0.95%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    PULMONARY TUBERCULOSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYELONEPHRITIS
         subjects affected / exposed
    4 / 1093 (0.37%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PYONEPHROSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RENAL CYST INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY SYNCYTIAL VIRUS INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION VIRAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    4 / 1093 (0.37%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    RHINOVIRUS INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPSIS
         subjects affected / exposed
    60 / 1093 (5.49%)
    57 / 1048 (5.44%)
         occurrences causally related to treatment / all
    0 / 71
    0 / 61
         deaths causally related to treatment / all
    0 / 16
    0 / 13
    SEPTIC ARTHRITIS STAPHYLOCOCCAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPTIC EMBOLUS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPTIC ENCEPHALOPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    SEPTIC NECROSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SEPTIC SHOCK
         subjects affected / exposed
    2 / 1093 (0.18%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    SOFT TISSUE INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SPLENIC ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    STAPHYLOCOCCAL BACTERAEMIA
         subjects affected / exposed
    8 / 1093 (0.73%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    STAPHYLOCOCCAL SEPSIS
         subjects affected / exposed
    5 / 1093 (0.46%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 1
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    STREPTOCOCCAL SEPSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUBCUTANEOUS ABSCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TONSILLITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TOOTH ABSCESS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TUBERCULOSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URETHRITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    URINARY TRACT INFECTION
         subjects affected / exposed
    29 / 1093 (2.65%)
    18 / 1048 (1.72%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    UROSEPSIS
         subjects affected / exposed
    18 / 1093 (1.65%)
    11 / 1048 (1.05%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    URINARY TRACT INFECTION PSEUDOMONAL
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIRAL INFECTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WOUND INFECTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Stroke
         subjects affected / exposed
    12 / 1093 (1.10%)
    13 / 1048 (1.24%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 12
    0 / 13
    AIR EMBOLISM
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANEURYSM RUPTURED
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ANGIOPATHY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC ANEURYSM
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    AORTIC CALCIFICATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    AORTIC STENOSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ARTERIAL DISORDER
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOSCLEROSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS FISTULA
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BRACHIOCEPHALIC ARTERY OCCLUSION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CIRCULATORY COLLAPSE
         subjects affected / exposed
    17 / 1093 (1.56%)
    16 / 1048 (1.53%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 18
         deaths causally related to treatment / all
    0 / 5
    0 / 4
    DEEP VEIN THROMBOSIS
         subjects affected / exposed
    3 / 1093 (0.27%)
    4 / 1048 (0.38%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    DIABETIC VASCULAR DISORDER
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMBOLISM
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENOUS EMBOLISM
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EXTREMITY NECROSIS
         subjects affected / exposed
    5 / 1093 (0.46%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    HAEMATOMA
         subjects affected / exposed
    6 / 1093 (0.55%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HAEMORRHAGE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    10 / 1093 (0.91%)
    6 / 1048 (0.57%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    HYPERTENSIVE CRISIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYPOTENSION
         subjects affected / exposed
    20 / 1093 (1.83%)
    18 / 1048 (1.72%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    HYPOVOLAEMIC SHOCK
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    INTERMITTENT CLAUDICATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT HYPERTENSION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MICROSCOPIC POLYANGIITIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ORTHOSTATIC HYPOTENSION
         subjects affected / exposed
    4 / 1093 (0.37%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ARTERY THROMBOSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PERIPHERAL ISCHAEMIA
         subjects affected / exposed
    14 / 1093 (1.28%)
    22 / 1048 (2.10%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 25
         deaths causally related to treatment / all
    0 / 4
    0 / 7
    PERIPHERAL VASCULAR DISORDER
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    STEAL SYNDROME
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SUPERIOR VENA CAVA SYNDROME
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    THROMBOSIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VASCULAR STENOSIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENOUS OCCLUSION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENOUS STENOSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VENA CAVA THROMBOSIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    TEMPORAL ARTERITIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    POOR VENOUS ACCESS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    ABSCESS DRAINAGE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AMPUTATION OF PENIS
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    ANEURYSM REPAIR
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANGIOPLASTY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ANKLE OPERATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    AORTIC VALVE REPLACEMENT
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS FISTULA OPERATION
         subjects affected / exposed
    29 / 1093 (2.65%)
    18 / 1048 (1.72%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ARTERIOVENOUS GRAFT
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BLADDER NECK OPERATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    BUNION OPERATION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARDIAC PACEMAKER INSERTION
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CARPAL TUNNEL DECOMPRESSION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATHETER PLACEMENT
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CATHETER REMOVAL
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CENTRAL VENOUS CATHETERISATION
         subjects affected / exposed
    3 / 1093 (0.27%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CHOLECYSTECTOMY
         subjects affected / exposed
    0 / 1093 (0.00%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ANGIOPLASTY
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERIAL STENT INSERTION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    CORONARY ARTERY BYPASS
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DEBRIDEMENT
         subjects affected / exposed
    1 / 1093 (0.09%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIALYSIS
         subjects affected / exposed
    2 / 1093 (0.18%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DIALYSIS DEVICE INSERTION
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    DRUG THERAPY
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    EMERGENCY CARE
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    EMPYEMA DRAINAGE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    ENDOTRACHEAL INTUBATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    FINGER AMPUTATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FISTULA REPAIR
         subjects affected / exposed
    3 / 1093 (0.27%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    FOOT AMPUTATION
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GASTROINTESTINAL SURGERY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    GENITOURINARY OPERATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HERNIA REPAIR
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    HIP ARTHROPLASTY
         subjects affected / exposed
    1 / 1093 (0.09%)
    2 / 1048 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    HOSPITALISATION
         subjects affected / exposed
    2 / 1093 (0.18%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    HYSTERECTOMY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ILEOSTOMY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL DRAINAGE
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA REPAIR
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    INTRAVENOUS CATHETER MANAGEMENT
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    KNEE ARTHROPLASTY
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LEG AMPUTATION
         subjects affected / exposed
    7 / 1093 (0.64%)
    7 / 1048 (0.67%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LESION EXCISION
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    LIMB AMPUTATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MALIGNANT TUMOUR EXCISION
         subjects affected / exposed
    1 / 1093 (0.09%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MASTECTOMY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MENISCUS OPERATION
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    NEPHRECTOMY
         subjects affected / exposed
    2 / 1093 (0.18%)
    3 / 1048 (0.29%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    OPEN REDUCTION OF FRACTURE
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    OVARIOCENTESIS
         subjects affected / exposed
    0 / 1093 (0.00%)
    1 / 1048 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PANCREATICODUODENECTOMY
         subjects affected / exposed
    1 / 1093 (0.09%)
    0 / 1048 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARATHYROIDECTOMY
         subjects affected / exposed
    9 / 1093 (0.82%)
    5 / 1048 (0.48%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    PARTIAL LUNG RESECTION
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