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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome Event

    Summary
    EudraCT number
    		 2009-012852-26
    Trial protocol
    		 ES   DE   PT   GB   LT   EE   DK   LV   IT   NL   SE   FR   FI   BG   BE   NO   AT  
    Global end of trial date
    11 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Jul 2016
    First version publication date
    29 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    EFC11319
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01147250
    WHO universal trial number (UTN)
    		 U1111-1116-5558
    Other trial identifiers
    		 Study Name: ELIXA
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Mar 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that lixisenatide can reduce cardiovascular (CV) morbidity and mortality [composite endpoint of CV death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina] compared to placebo in type 2 diabetic subjects who recently experienced a spontaneous, biomarker-positive acute coronary syndrome (ACS) event.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial via informed consent form (ICF) with investigator as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Antidiabetic medications were permitted (except other glucagon like peptide-1 [GLP1] receptor agonist or dipeptidyl peptidase-IV [DPP-IV] inhibitors) . Adjustment was allowed in order to manage glycemic control in accordance with clinical practice guidelines.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 27
    Country: Number of subjects enrolled
    Norway: 30
    Country: Number of subjects enrolled
    Poland: 250
    Country: Number of subjects enrolled
    Portugal: 24
    Country: Number of subjects enrolled
    Romania: 230
    Country: Number of subjects enrolled
    Spain: 154
    Country: Number of subjects enrolled
    Sweden: 43
    Country: Number of subjects enrolled
    United Kingdom: 125
    Country: Number of subjects enrolled
    Austria: 4
    Country: Number of subjects enrolled
    Belgium: 15
    Country: Number of subjects enrolled
    Bulgaria: 76
    Country: Number of subjects enrolled
    Denmark: 54
    Country: Number of subjects enrolled
    Estonia: 52
    Country: Number of subjects enrolled
    Finland: 44
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    Germany: 96
    Country: Number of subjects enrolled
    Italy: 69
    Country: Number of subjects enrolled
    Latvia: 56
    Country: Number of subjects enrolled
    Lithuania: 48
    Country: Number of subjects enrolled
    Argentina: 399
    Country: Number of subjects enrolled
    Australia: 17
    Country: Number of subjects enrolled
    Belarus: 34
    Country: Number of subjects enrolled
    Brazil: 448
    Country: Number of subjects enrolled
    Canada: 111
    Country: Number of subjects enrolled
    Chile: 246
    Country: Number of subjects enrolled
    China: 113
    Country: Number of subjects enrolled
    Colombia: 265
    Country: Number of subjects enrolled
    Ecuador: 27
    Country: Number of subjects enrolled
    Egypt: 6
    Country: Number of subjects enrolled
    Georgia: 58
    Country: Number of subjects enrolled
    Guatemala: 142
    Country: Number of subjects enrolled
    India: 317
    Country: Number of subjects enrolled
    Israel: 65
    Country: Number of subjects enrolled
    Japan: 103
    Country: Number of subjects enrolled
    Korea, Republic of: 74
    Country: Number of subjects enrolled
    Mexico: 301
    Country: Number of subjects enrolled
    Panama: 9
    Country: Number of subjects enrolled
    Peru: 107
    Country: Number of subjects enrolled
    Philippines: 50
    Country: Number of subjects enrolled
    Russian Federation: 587
    Country: Number of subjects enrolled
    Serbia: 69
    Country: Number of subjects enrolled
    South Africa: 130
    Country: Number of subjects enrolled
    Switzerland: 8
    Country: Number of subjects enrolled
    Taiwan: 29
    Country: Number of subjects enrolled
    Tunisia: 26
    Country: Number of subjects enrolled
    Turkey: 55
    Country: Number of subjects enrolled
    Ukraine: 127
    Country: Number of subjects enrolled
    United Arab Emirates: 14
    Country: Number of subjects enrolled
    United States: 696
    Worldwide total number of subjects
    6068
    EEA total number of subjects
    1435
    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)
    4025
    From 65 to 84 years
    2023
    85 years and over
    20

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 828 centers in 49 countries between June 24, 2010 and July 24, 2013. A total of 7719 subjects were screened, 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.

    Pre-assignment
    Screening details
    		 7627 subjects underwent 1 week placebo run–in period. 1559 were run-in failures due to exclusion criteria met. A total of 6068 subjects were randomized 1:1 to lixisenatide and placebo arms in double-blind treatment period. Duration of study was event driven until approximately 844 positively adjudicated primary CV outcome events.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo matched to lixisenatide once daily (QD) up to end of treatment (median exposure 23 months).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Volume-matched placebo was self-administered QD within 1 hour before breakfast in the morning.

    Arm title
    		 Lixisenatide
    Arm description
    		 Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure 22 months).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Lixisenatide
    Investigational medicinal product code
    AVE0010
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Lixisenatide was self-administered QD within 1 hour before breakfast in the morning. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.

    Number of subjects in period 1
    		Placebo Lixisenatide
    Started
    3034
    3034
    Treated
    3032
    3031
    Completed
    2924
    2929
    Not completed
    110
    105
         Consent withdrawn by subject
    83
    88
         Site termination by sponsor
    13
    5
         Other than specified
    -
    1
         Lost to follow-up
    14
    11

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to lixisenatide once daily (QD) up to end of treatment (median exposure 23 months).

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure 22 months).

    Reporting group values
    		 Placebo Lixisenatide Total
    Number of subjects
    		 3034 3034 6068
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 60.6 ( 9.6 ) 59.9 ( 9.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 938 923 1861
        Male
    		 2096 2111 4207
    Race
    Units: Subjects
        Caucasian/White
    		 2318 2258 4576
        Black
    		 103 118 221
        Asian/Oriental
    		 367 404 771
        Other
    		 246 254 500
    Ethnicity
    Units: Subjects
        Hispanic
    		 903 865 1768
        Not Hispanic
    		 2131 2169 4300
    Qualifying ACS event
    Units: Subjects
        ST-segment elevation MI
    		 1317 1349 2666
        Non ST-segment elevation MI
    		 1183 1165 2348
        Unstable angina
    		 528 514 1042
        Unclassified
    		 4 5 9
        Not qualifying ACS event
    		 2 1 3
    Body Mass Index (BMI)
    N=3032, 3033
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 30.2 ( 5.79 ) 30.12 ( 5.6 ) -
    Body Weight
    N=3032, 3033
    Units: kg
        arithmetic mean (standard deviation)
    		 85.06 ( 19.64 ) 84.64 ( 19.21 ) -
    Glycosylated Hemoglobin (HbA1c)
    N=3033, 3034
    Units: Percentage of HbA1c
        arithmetic mean (standard deviation)
    		 7.64 ( 1.28 ) 7.72 ( 1.32 ) -
    Duration of Diabetes
    N=3034, 3031
    Units: Years
        arithmetic mean (standard deviation)
    		 9.38 ( 8.32 ) 9.2 ( 8.19 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo matched to lixisenatide once daily (QD) up to end of treatment (median exposure 23 months).

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure 22 months).

    Primary: Time to First Occurence of Primary CV Event: CV Death, Non-fatal MI, Non-fatal Stroke or Hospitalization for Unstable Angina

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    End point title
    		 Time to First Occurence of Primary CV Event: CV Death, Non-fatal MI, Non-fatal Stroke or Hospitalization for Unstable Angina
    End point description
    Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed subjects with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events. Analysis was done on intent-to-treat (ITT) population defined as all randomized subjects analyzed according to the treatment group allocated at randomization.
    End point type
    Primary
    End point timeframe
    From randomization up to the end of study (median follow-up of 25 months)
    End point values
    		 Placebo Lixisenatide
    Number of subjects analysed
    3034
    3034
    Units: subjects
        number (not applicable)
    399
    406
    Statistical analysis title
    		 Lixisenatide vs Placebo
    Statistical analysis description
    Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% confidence interval (CI).
    Comparison groups
    Lixisenatide v Placebo
    Number of subjects included in analysis
    6068
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.017
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.886
         upper limit
    		 1.168
    Statistical analysis title
    		 Lixisenatide vs Placebo
    Statistical analysis description
    Analysis was performed using Cox proportional hazards model with treatment groups, and region (North America, South and Central America, Western Europe, Eastern Europe, Africa/Near East, and Asia/Pacific) as covariates, and the associated two-sided 95% CI.
    Comparison groups
    Lixisenatide v Placebo
    Number of subjects included in analysis
    6068
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8542 [1]
    Method
    		 Cox proportional hazard model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.017
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.886
         upper limit
    		 1.168
    Notes
    [1] - P-value was calculated using log-rank test.

    Secondary: Time to First Occurence of CV Event: CV Death, Non-fatal MI, Non-fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure

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    End point title
    		 Time to First Occurence of CV Event: CV Death, Non-fatal MI, Non-fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure
    End point description
    All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed subjects with endpoint events were reported. Analysis was done on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to the end of study (median follow-up of 25 months)
    End point values
    		 Placebo Lixisenatide
    Number of subjects analysed
    3034
    3034
    Units: subjects
        number (not applicable)
    469
    456
    No statistical analyses for this end point

    Secondary: Time to First Occurence of CV Event: CV Death, Non-fatal MI, Non-fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure

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    End point title
    		 Time to First Occurence of CV Event: CV Death, Non-fatal MI, Non-fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure
    End point description
    All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed subjects with endpoint events were reported. Analysis was done on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to the end of study (median follow-up of 25 months)
    End point values
    		 Placebo Lixisenatide
    Number of subjects analysed
    3034
    3034
    Units: subjects
        number (not applicable)
    659
    661
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in The Urinary Albumin/Creatinine Ratio (UACR) at Week 108

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    End point title
    		 Percent Change From Baseline in The Urinary Albumin/Creatinine Ratio (UACR) at Week 108
    End point description
    Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean. Analysis was performed on ITT population. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 108 (LOCF)
    End point values
    		 Placebo Lixisenatide
    Number of subjects analysed
    2830
    2803
    Units: Percent change
        geometric mean (standard error)
    34.21 ( 3.09 )
    24.17 ( 2.84 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form up to study end regardless of seriousness or relationship to IMP. Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame.
    Adverse event reporting additional description
    Reporteds AEs and deaths are treatment emergent that is AEs that developed/worsened and deaths that occurred during ‘on treatment period’ (time from first administration of IMP up to 3 days after last administration of IMP). All cause deaths include cardiovascular deaths (primary efficacy endpoint) and non cardiovascular deaths resulting from AEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Subjects exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)

    Reporting group title
    Lixisenatide
    Reporting group description
    		 Subjects exposed to Lixisenatide 10 mcg QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)

    Serious adverse events
    		 Placebo Lixisenatide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    669 / 3032 (22.06%)
    625 / 3031 (20.62%)
         number of deaths (all causes)
    96
    93
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma Gastric
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma Of Colon
         subjects affected / exposed
    2 / 3032 (0.07%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Adenocarcinoma Pancreas
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenosquamous Cell Lung Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Lymphoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Unclassifiable Lymphoma Low Grade
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal Cell Carcinoma
         subjects affected / exposed
    5 / 3032 (0.16%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Renal Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Salivary Gland Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Small Intestinal Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    4 / 3032 (0.13%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Neoplasm
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Neoplasm
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear Cell Renal Cell Carcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer Recurrent
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Neoplasm
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Adenocarcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endometrial Cancer
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibromatosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Cancer Stage Iv
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma Multiforme
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular Carcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Iris Melanoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Cancer Metastatic
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Pleural Effusion
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Central Nervous System
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Liver
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Lung
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Pancreas
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Pain
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian Cancer
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian Cancer Stage Iii
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ovarian Epithelial Cancer
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 2
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Papillary Thyroid Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal Cancer
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary Tumour Benign
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    7 / 3032 (0.23%)
    10 / 3031 (0.33%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Stage I
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Adenoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenocarcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer Metastatic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Cell Carcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal Neoplasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Salivary Gland Neoplasm
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small Cell Lung Cancer Metastatic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Small Intestine Adenocarcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of Lung
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of Skin
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Neoplasm
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated Hypertension
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Dissection
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Thrombosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Occlusive Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteritis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Pressure Inadequately Controlled
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Vascular Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential Hypertension
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Artery Aneurysm
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granulomatosis With Polyangiitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    9 / 3032 (0.30%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    13 / 3032 (0.43%)
    15 / 3031 (0.49%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Emergency
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    6 / 3032 (0.20%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent Claudication
         subjects affected / exposed
    4 / 3032 (0.13%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche Syndrome
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    4 / 3032 (0.13%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    7 / 3032 (0.23%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Aneurysm
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Embolism
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    4 / 3032 (0.13%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Venous Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock Haemorrhagic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Occlusion
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Stenosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis Necrotising
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis Limb
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardioplegia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystectomy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Debridement
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Arthroplasty
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implantable Defibrillator Insertion
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular Lens Implant
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Arthroplasty
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leg Amputation
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Bypass
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurodesis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toe Amputation
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Arterial Restenosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 3032 (0.00%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Coronary Artery Restenosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    2 / 3032 (0.07%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Gait Disturbance
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Healing
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Extravasation
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Local Swelling
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    42 / 3032 (1.39%)
    46 / 3031 (1.52%)
         occurrences causally related to treatment / all
    0 / 48
    0 / 52
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema Peripheral
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis In Device
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic Reaction
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Shock
         subjects affected / exposed
    0 / 3032 (0.00%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Joint Prosthesis User
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Adenomyosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    2 / 3032 (0.07%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst Ruptured
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Ulceration
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    5 / 3032 (0.16%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    4 / 3032 (0.13%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthmatic Crisis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    14 / 3032 (0.46%)
    15 / 3031 (0.49%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    3 / 3032 (0.10%)
    7 / 3031 (0.23%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea Exertional
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Laryngeal Stenosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infiltration
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Airways Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngeal Mass
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pickwickian Syndrome
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    4 / 3032 (0.13%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    8 / 3032 (0.26%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Toxicity
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Acidosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    2 / 3032 (0.07%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Abuse
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed Suicide
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Confusional State
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conversion Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mania
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychogenic Seizure
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    7 / 3032 (0.23%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiogram
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Abnormal
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Increased
         subjects affected / exposed
    4 / 3032 (0.13%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Pressure Increased
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Sodium Decreased
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbohydrate Antigen 19-9 Increased
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catheterisation Cardiac
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crystal Urine Present
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram Abnormal
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated Haemoglobin Increased
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Specific Antigen Increased
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urine Output Decreased
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental Overdose
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic Transfusion Reaction
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod Sting
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Contusion
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cartilage Injury
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    7 / 3032 (0.23%)
    7 / 3031 (0.23%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femoral Neck Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand Fracture
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    8 / 3032 (0.26%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision Site Haematoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medication Error
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Discharge
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Fever
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thoracic Procedure Complication
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Haematoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Injury
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sports Injury
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural Haematoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    23 / 3032 (0.76%)
    23 / 3031 (0.76%)
         occurrences causally related to treatment / all
    0 / 24
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    30 / 3032 (0.99%)
    23 / 3031 (0.76%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Flutter
         subjects affected / exposed
    5 / 3032 (0.16%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    8 / 3032 (0.26%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block First Degree
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bifascicular Block
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    5 / 3032 (0.16%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardio-Respiratory Arrest
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    5 / 3032 (0.16%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Heart Disease
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac Thrombus
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Dysfunction
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Ischaemia
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         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 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sick Sinus Syndrome
         subjects affected / exposed
    5 / 3032 (0.16%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    4 / 3032 (0.13%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular Block
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    8 / 3032 (0.26%)
    9 / 3031 (0.30%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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 / 3032 (0.03%)
    0 / 3031 (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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Dissection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Occlusion
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    6 / 3032 (0.20%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal Tunnel Syndrome
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Radiculopathy
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed Level Of Consciousness
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential Tremor
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Nerve Disorder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paresis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 3032 (0.00%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Unconsciousness
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Haematoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    4 / 3032 (0.13%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Morton's Neuralgia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Sclerosis Relapse
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic Neuritis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Sensorimotor Neuropathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    0 / 3032 (0.00%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychomotor Hyperactivity
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyramidal Tract Syndrome
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial Nerve Palsy
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Pain
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculitis Lumbosacral
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    16 / 3032 (0.53%)
    16 / 3031 (0.53%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viith Nerve Paralysis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    9 / 3032 (0.30%)
    8 / 3031 (0.26%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Increased Tendency To Bruise
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic Anaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pernicious Anaemia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness Neurosensory
         subjects affected / exposed
    0 / 3032 (0.00%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Hearing Loss
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Labyrinthine
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis Fugax
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angle Closure Glaucoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerotic Retinopathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness Unilateral
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    5 / 3032 (0.16%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Nuclear
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Eye Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Retinal Oedema
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open Angle Glaucoma
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmoplegia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uveitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Haemorrhage
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Distension
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Hernia
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Incarcerated Hernia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    7 / 3032 (0.23%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    3 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Rigidity
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wall Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gastroparesis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 3032 (0.13%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    3 / 3032 (0.10%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epigastric Discomfort
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecal Vomiting
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Polyps
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    4 / 3032 (0.13%)
    7 / 3031 (0.23%)
         occurrences causally related to treatment / all
    1 / 4
    3 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Haemorrhagic
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis Haemorrhagic
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    6 / 3032 (0.20%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival Bleeding
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Gastric Emptying
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    3 / 3032 (0.10%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Ischaemia
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal Obstruction
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    3 / 3032 (0.10%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss Syndrome
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction Gastric
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Ulcer
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Ulcer Haemorrhage
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia, Obstructive
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    4 / 3032 (0.13%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Vomiting
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Bile Duct Stone
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    5 / 3032 (0.16%)
    9 / 3031 (0.30%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    7 / 3032 (0.23%)
    10 / 3031 (0.33%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    6 / 3032 (0.20%)
    13 / 3031 (0.43%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-Induced Liver Injury
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Polyp
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Function Abnormal
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Hepatitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Injury
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic Foot
         subjects affected / exposed
    4 / 3032 (0.13%)
    8 / 3031 (0.26%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus Generalised
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    10 / 3032 (0.33%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling Face
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Bladder
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Ureteric
         subjects affected / exposed
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus Urinary
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    8 / 3032 (0.26%)
    7 / 3031 (0.23%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy Toxic
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Artery Stenosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    5 / 3032 (0.16%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Failure Acute
         subjects affected / exposed
    20 / 3032 (0.66%)
    20 / 3031 (0.66%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Failure Chronic
         subjects affected / exposed
    4 / 3032 (0.13%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Impairment
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Meatus Stenosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Haemorrhage
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperparathyroidism
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    4 / 3032 (0.13%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Pain
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coccydynia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's Contracture
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fasciitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture Malunion
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Instability
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Discomfort
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    7 / 3032 (0.23%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Extremity
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain In Jaw
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    0 / 3032 (0.00%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigger Finger
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Sepsis
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal Wall Infection
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    3 / 3032 (0.10%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic Dysentery
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    2 / 3032 (0.07%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 3032 (0.10%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Infective
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Pyelonephritis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 3032 (0.07%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Bacterial
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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 / 3032 (0.07%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Burn Infection
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbuncle
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cat Scratch Disease
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    18 / 3032 (0.59%)
    17 / 3031 (0.56%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Hepatitis B
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Hepatitis C
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Sinusitis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea Infectious
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    7 / 3032 (0.23%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Abscess
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    7 / 3032 (0.23%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Viral
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    9 / 3032 (0.30%)
    13 / 3031 (0.43%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Clostridial
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    H1n1 Influenza
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma Infection
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter Gastritis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bites
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation Of Chronic Obstructive Airways Disease
         subjects affected / exposed
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella Sepsis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar Pneumonia
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    4 / 3032 (0.13%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    3 / 3032 (0.10%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterial Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nail Bed Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    9 / 3032 (0.30%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Acute
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Chronic
         subjects affected / exposed
    2 / 3032 (0.07%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Fungal
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media Chronic
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraspinal Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paronychia
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 3032 (0.07%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal Cyst
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy Viral
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    51 / 3032 (1.68%)
    36 / 3031 (1.19%)
         occurrences causally related to treatment / all
    0 / 59
    0 / 36
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 3032 (0.03%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    5 / 3032 (0.16%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoas Abscess
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sepsis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture Site Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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 / 3032 (0.13%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    4 / 3032 (0.13%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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 / 3032 (0.13%)
    6 / 3031 (0.20%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Abscess
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    10 / 3032 (0.33%)
    8 / 3031 (0.26%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 8
         deaths causally related to treatment / all
    0 / 3
    1 / 4
    Septic Shock
         subjects affected / exposed
    3 / 3032 (0.10%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Soft Tissue Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Infection
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Osteomyelitis
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    3 / 3032 (0.10%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdiaphragmatic Abscess
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tick-Borne Fever
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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
    0 / 3032 (0.00%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxoplasmosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         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
    3 / 3032 (0.10%)
    3 / 3031 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    19 / 3032 (0.63%)
    18 / 3031 (0.59%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Corneal Ulcer
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (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 / 3032 (0.03%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    2 / 3032 (0.07%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    18 / 3032 (0.59%)
    8 / 3031 (0.26%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    4 / 3032 (0.13%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Metabolic Decompensation
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    7 / 3032 (0.23%)
    4 / 3031 (0.13%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    4 / 3032 (0.13%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    10 / 3032 (0.33%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    3 / 11
    4 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    2 / 3031 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 3032 (0.13%)
    5 / 3031 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 3032 (0.03%)
    1 / 3031 (0.03%)
         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 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    0 / 3032 (0.00%)
    1 / 3031 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 3032 (0.03%)
    0 / 3031 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Lixisenatide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1270 / 3032 (41.89%)
    1597 / 3031 (52.69%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    171 / 3032 (5.64%)
    152 / 3031 (5.01%)
         occurrences all number
    211
    197
    Cardiac disorders
    Angina Pectoris
         subjects affected / exposed
    200 / 3032 (6.60%)
    177 / 3031 (5.84%)
         occurrences all number
    267
    217
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    191 / 3032 (6.30%)
    259 / 3031 (8.55%)
         occurrences all number
    260
    353
    Headache
         subjects affected / exposed
    148 / 3032 (4.88%)
    187 / 3031 (6.17%)
         occurrences all number
    205
    247
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    171 / 3032 (5.64%)
    137 / 3031 (4.52%)
         occurrences all number
    217
    175
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    227 / 3032 (7.49%)
    237 / 3031 (7.82%)
         occurrences all number
    313
    308
    Nausea
         subjects affected / exposed
    179 / 3032 (5.90%)
    659 / 3031 (21.74%)
         occurrences all number
    259
    1027
    Vomiting
         subjects affected / exposed
    82 / 3032 (2.70%)
    257 / 3031 (8.48%)
         occurrences all number
    100
    378
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    188 / 3032 (6.20%)
    181 / 3031 (5.97%)
         occurrences all number
    259
    238
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    554 / 3032 (18.27%)
    609 / 3031 (20.09%)
         occurrences all number
    2137
    2285

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Dec 2010
    Following amendments were done: - Clarification regarding the inclusion/exclusion criteria taking into account the recommendation of the study committees (SC). -Addition of elevated cardiac injury biomarkers [troponin or creatin kinase (CK)-MB] as a requirement for the qualifying ACS event.- Clarification of the exclusion criteria related to cardiac procedures like coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI) and angiography. -Collection of blood samples for metabolic, inflammatory, and CV biomarkers for storage. -Optional pharmacogenetic testing, which was to be done only when the subject had signed a separate informed consent for pharmacogenetic sampling.- The end date of the study would be driven by accumulation of the primary adjudicated events and would happen when the study had accumulated 844 positively adjudicated primary CV outcome events. -Re-screening of subjects was allowed based upon both the investigator’s medical judgment and the Sponsor’s agreement. Nevertheless, one subject could be randomized only one time. -Patient-reported outcome (PRO) endpoints were added.-Definitions of components of the composite CV efficacy endpoints from the protocol were removed as these definitions were to be provided in the CAC Manual of operations. -The endpoint “hospitalization for coronary revascularization procedure” was replaced with “coronary revascularization procedure”. - 15 mcg QD dose was allowed in case the 20 mcg QD dose was not tolerated. - The wording for the section “Monitoring of suspected pancreatitis was revised, based upon recommendations from pancreatitis experts.
    27 Jul 2011
    Following changes were made: -The objective was revised, based on the results of a recent animal study. The revised objective of the study was to demonstrate a beneficial cardiac outcome, “to demonstrate that lixisenatide can reduce CV morbidity and mortality (composite endpoint of CV death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina) compared to placebo in subjects with type 2 diabetes melitus (T2DM) who recently experienced a spontaneous, biomarker-positive ACS event”. - Inclusion and exclusion criteria were revised. -The procedure of pre-screening and signing of informed consent was modified, as candidate trial subjects could best be identified in the critical care facilities during their qualifying ACS admission. -The study period was modified, as the study recruitment was slower than previously predicted; an additional 10 months were added to the recruitment period. -Glycemia Committee was added as a study committee. - The rules for withdrawal from treatment were modified in order to ensure that subjects who developed severe renal dysfunction would permanently discontinue IMP.
    06 Feb 2014
    Following changes were made: -The maximal study duration was extended up to 58 months for each subject in order to allow all subjects to continue their participation after December 2013. - Addition of a new safety committee, Pancreatic Safety Assessment Committee (PSAC), since some cases of acute pancreatitis had been spontaneously reported with other marketed glucagon like peptide-1 (GLP-1) receptor agonists, and a possible association between GLP-1-based therapies and acute pancreatitis could not be fully excluded. The PSAC was to review all pancreatic events that had been reported on a specific pancreatic event AE form. The statistical analysis of these events was also added. -Change in the dose adaptation rules of the IMPs to allow for dosing at dinner time. - Change in reporting timeline from “within 1 working day” to “within 24 hours” for serious adverse events (SAEs) to comply with Ethics committee (EC) guidance document and same changes for AEs with prespecified monitoring with immediate notification were done. - Additional contacts with subjects were requested to collect CV endpoint events, since excessive accumulation of non-adjudicated events would directly affect the study timelines. - Categories of estimated glomerular filtration rate (eGFR) were modified following Food and Drug Administration (FDA) guidance.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25965710
    http://www.ncbi.nlm.nih.gov/pubmed/26630143
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