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    Clinical Trial Results:
    A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban with Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects with Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

    Summary
    EudraCT number
    		 2013-000046-19
    Trial protocol
    		 ES   CZ   DE   NL   BG   PL   HU   SE   IT   GB   EE   LT   PT   DK   LV   SK   GR  
    Global end of trial date
    02 May 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 May 2019
    First version publication date
    04 May 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RIVAROXHFA3001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01877915
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920, Route 202 South, Raritan, NJ, United States, 08869
    Public contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.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 May 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 May 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to demonstrate that rivaroxaban was superior to placebo in subjects with heart failure (HF) and significant coronary artery disease (CAD), who were receiving standard care, in reducing the risk of the composite of all-cause mortality (ACM), myocardial infarction (MI), or stroke following an index event.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices (GCP) and applicable regulatory requirements. Safety was assessed by the evaluation of the principal safety outcome, other bleeding outcomes, Adverse Events and laboratory evaluations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 152
    Country: Number of subjects enrolled
    Australia: 14
    Country: Number of subjects enrolled
    Bulgaria: 628
    Country: Number of subjects enrolled
    Brazil: 160
    Country: Number of subjects enrolled
    Canada: 28
    Country: Number of subjects enrolled
    China: 372
    Country: Number of subjects enrolled
    Czech Republic: 69
    Country: Number of subjects enrolled
    Germany: 64
    Country: Number of subjects enrolled
    Denmark: 18
    Country: Number of subjects enrolled
    Spain: 178
    Country: Number of subjects enrolled
    France: 20
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    Greece: 16
    Country: Number of subjects enrolled
    Hungary: 138
    Country: Number of subjects enrolled
    Italy: 71
    Country: Number of subjects enrolled
    Japan: 265
    Country: Number of subjects enrolled
    Korea, Republic of: 48
    Country: Number of subjects enrolled
    Lithuania: 35
    Country: Number of subjects enrolled
    Latvia: 25
    Country: Number of subjects enrolled
    Mexico: 146
    Country: Number of subjects enrolled
    Malaysia: 34
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 578
    Country: Number of subjects enrolled
    Portugal: 42
    Country: Number of subjects enrolled
    Romania: 398
    Country: Number of subjects enrolled
    Russian Federation: 550
    Country: Number of subjects enrolled
    Slovakia: 82
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    Turkey: 192
    Country: Number of subjects enrolled
    Ukraine: 529
    Country: Number of subjects enrolled
    United States: 121
    Country: Number of subjects enrolled
    South Africa: 16
    Worldwide total number of subjects
    5022
    EEA total number of subjects
    2395
    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)
    2159
    From 65 to 84 years
    2709
    85 years and over
    154

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 5,667 subjects were screened for eligibility and 5,022 subjects were randomly assigned into 1 of the 2 treatment groups: rivaroxaban (N= 2,507) or matching placebo (N=2,515).

    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
    		 Investigator, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Rivaroxaban
    Arm description
    		 Subjects received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rivaroxaban 2.5 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 2.5 mg of rivaroxaban tablet orally twice daily.

    Arm title
    		 Placebo
    Arm description
    		 Subjects received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo orally twice daily.

    Number of subjects in period 1
    		Rivaroxaban Placebo
    Started
    2507
    2515
    Completed
    2453
    2447
    Not completed
    54
    68
         Consent withdrawn by subject
    42
    55
         Other
    2
    4
         Lost to follow-up
    10
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Subjects received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Reporting group values
    		 Rivaroxaban Placebo Total
    Number of subjects
    		 2507 2515 5022
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 1061 1098 2159
        From 65 to 84 years
    		 1379 1330 2709
        85 years and over
    		 67 87 154
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.5 ( 10.07 ) 66.3 ( 10.27 ) -
    Title for Gender
    Units: subjects
        Female
    		 551 599 1150
        Male
    		 1956 1916 3872

    End points

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    End points reporting groups
    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Subjects received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Primary: Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke

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    End point title
    		 Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
    End point description
    Event rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. Intent-to-Treat (ITT) analysis set included all randomized unique subjects who signed a valid informed consent. Subjects were analyzed according to the treatment group assigned, irrespective of the actual treatment received.
    End point type
    Primary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    13.44
    14.27
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Rivaroxaban v Placebo
    Number of subjects included in analysis
    5022
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.27
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.05

    Primary: Event Rate of Either Fatal Bleeding or Bleeding into a Critical Space with Potential for Permanent Disability

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    End point title
    		 Event Rate of Either Fatal Bleeding or Bleeding into a Critical Space with Potential for Permanent Disability
    End point description
    Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after bleeding event which required hospitalization or met ISTH major bleeding definition criteria. Fatal bleeding event included that met criteria in 3 1:Any ISTH major bleeding event considered to be primary cause of death by investigator; 2: ISTH major bleeding event not considered primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital and death within 7 days. Bleeding with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate based on time to first occurrence of event were reported in the study. Event Rate/(100 pt-yr=100*n/(total risk exposure), where n is number of events. SAS: subjects who received at least one dose of study drug. 'N':number of subjects evaluable for this outcome measure.
    End point type
    Primary
    End point timeframe
    Up to 227 Weeks
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2499
    2509
    Units: Event rate per 100 patient-year
    number (not applicable)
        Fatal Bleeding
    0.22
    0.22
        Critical Space Bleeding with Permanent Disability
    0.32
    0.48
    Statistical analysis title
    		 Statistical Analysis 1 (Fatal Bleeding)
    Comparison groups
    Rivaroxaban v Placebo
    Number of subjects included in analysis
    5008
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.951
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 2.59
    Statistical analysis title
    		 Statistical Analysis 2 (Permanent Disability)
    Comparison groups
    Rivaroxaban v Placebo
    Number of subjects included in analysis
    5008
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.253
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.34

    Secondary: Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)

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    End point title
    		 Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
    End point description
    Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. IIT analysis set included all randomized unique subjects who signed a valid informed consent. Subjects analyzed according to treatment group assigned, irrespective of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    23.32
    23.46
    No statistical analyses for this end point

    Secondary: Event Rate of Cardio Vascular Death

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    End point title
    		 Event Rate of Cardio Vascular Death
    End point description
    Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. IIT analysis set included all randomized unique subjects signed a valid informed consent. Subjects analyzed according to treatment group assigned, irrespective of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    9.46
    9.96
    No statistical analyses for this end point

    Secondary: Event Rate of Re-Hospitalization for Worsening of Heart Failure

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    End point title
    		 Event Rate of Re-Hospitalization for Worsening of Heart Failure
    End point description
    Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. IIT analysis set included all randomized unique subjects who signed a valid informed consent. Subjects analyzed according to treatment group assigned, irrespective of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    17.24
    17.45
    No statistical analyses for this end point

    Secondary: Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)

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    End point title
    		 Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
    End point description
    Event rate of RHCV were assessed. Hospitalization for a CV event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (eg, bleeding, arrhythmia, ACS, MI) other than HF which was captured in HF re-hospitalization. Event rate estimated based on time to first occurrence of the event were reported in study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. IIT analysis set included all randomized unique subjects who signed a valid informed consent. Subjects analyzed according to treatment group assigned, irrespective of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    13.30
    14.04
    No statistical analyses for this end point

    Secondary: Event Rate of all-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure

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    End point title
    		 Event Rate of all-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
    End point description
    Event rate of all-cause mortality (ACM) or re-hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. IIT analysis set included all randomized unique subjects who signed a valid informed consent. Subjects analyzed according to treatment group assigned, irrespective of actual treatment received.
    End point type
    Secondary
    End point timeframe
    Up to Global treatment end date (approximately 54 months)
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2507
    2515
    Units: Event rate per 100 patient-year
        number (not applicable)
    24.84
    24.57
    No statistical analyses for this end point

    Secondary: Event Rate of Bleeding Events that Requiring Hospitalization

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    End point title
    		 Event Rate of Bleeding Events that Requiring Hospitalization
    End point description
    Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. Safety Analysis Set (SAS) included all intent-to-treat subjects who received at least one dose of study drug. Here 'N' signifies number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 227 Weeks
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2499
    2509
    Units: Event rate per 100 patient-year
        number (not applicable)
    1.52
    1.16
    No statistical analyses for this end point

    Secondary: Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event

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    End point title
    		 Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
    End point description
    Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. Safety Analysis Set included all intent-to-treat subjects who received at least one dose of study drug. Here 'N' signifies number of subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 227 Weeks
    End point values
    		 Rivaroxaban Placebo
    Number of subjects analysed
    2499
    2509
    Units: Event rate per 100 patient-year
        number (not applicable)
    2.04
    1.21
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 54 Months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Rivaroxaban
    Reporting group description
    		 Subjects received 2.5 milligram (mg) tablet of rivaroxaban orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects received matching placebo orally twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the subject's managing physician).

    Serious adverse events
    		 Rivaroxaban Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    479 / 2507 (19.11%)
    451 / 2515 (17.93%)
         number of deaths (all causes)
    565
    571
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Myeloid Leukaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of Colon
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    6 / 2507 (0.24%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bladder Cancer Recurrent
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Stage Ii
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Neoplasm
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cervix Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear Cell Renal Cell Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Colon Cancer
         subjects affected / exposed
    7 / 2507 (0.28%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    2 / 2
    1 / 1
    Colon Cancer Metastatic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Colon Cancer Recurrent
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Adenocarcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Cancer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear Neoplasm Malignant
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Cancer Metastatic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Epiglottic Carcinoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Cancer
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Gastric Cancer
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer Recurrent
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Cancer
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic Cancer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cancer Stage Iv
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hypopharyngeal Cancer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intestinal Adenocarcinoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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 / 2507 (0.04%)
    0 / 2515 (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
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung Cancer Metastatic
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Lung Carcinoma Cell Type Unspecified Stage Ii
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Lung Neoplasm
         subjects affected / exposed
    1 / 2507 (0.04%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Lung Neoplasm Malignant
         subjects affected / exposed
    7 / 2507 (0.28%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 7
    1 / 7
         deaths causally related to treatment / all
    5 / 5
    1 / 1
    Lymphoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Malignant Melanoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Neoplasm of Unknown Primary Site
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Meningioma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Bone
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to Central Nervous System
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastases to Liver
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Metastases to Lung
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Neoplasm
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Metastatic Renal Cell Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Monoclonal Gammopathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm Malignant
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Neoplasm of Orbit
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Adenocarcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Plasma Cell Myeloma
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    4 / 2507 (0.16%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Prostate Cancer Metastatic
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Stage Iv
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Adenoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         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 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer Stage Iii
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Rectal Neoplasm
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    2 / 2507 (0.08%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Renal Cancer Metastatic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Neoplasm
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestine Carcinoma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Testis Cancer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Throat Cancer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Cancer
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Tongue Neoplasm
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Neoplasm Malignant Stage Unspecified
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Carcinoma
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Haemorrhage
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Cryoglobulinaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Vascular Disorder
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    3 / 2507 (0.12%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypertension
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    4 / 2507 (0.16%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis Superficial
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian Artery Stenosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    Anal Sphincterotomy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stent Removal
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Tumour Excision
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Operation
         subjects affected / exposed
    3 / 2507 (0.12%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chemotherapy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyst Removal
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Debridement
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Management
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Therapy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia Repair
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileostomy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia Repair
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insertion of Ambulatory Peritoneal Catheter
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Bypass
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prosthetic Vessel Implantation
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Removal of Ambulatory Peritoneal Catheter
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fusion Surgery
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Laminectomy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transurethral Prostatectomy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    5 / 2507 (0.20%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    2 / 5
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    3 / 3
    Disuse Syndrome
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Drug Withdrawal Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Heteroplasia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia Malignant
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired Healing
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    5 / 2507 (0.20%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    5 / 5
    3 / 3
    Non-Cardiac Chest Pain
         subjects affected / exposed
    7 / 2507 (0.28%)
    6 / 2515 (0.24%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    4 / 2507 (0.16%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Inflammation
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gynaecomastia
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst Torsion
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Pulmonary Oedema
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    2 / 2507 (0.08%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Asthma
         subjects affected / exposed
    5 / 2507 (0.20%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    15 / 2507 (0.60%)
    16 / 2515 (0.64%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 21
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Cough
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    4 / 2507 (0.16%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea Paroxysmal Nocturnal
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising Bronchiolitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Pleural Effusion
         subjects affected / exposed
    3 / 2507 (0.12%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Pneumothorax
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Fibrosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Arrest
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    9 / 2507 (0.36%)
    5 / 2515 (0.20%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    4 / 4
    3 / 3
    Respiratory Tract Inflammation
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Thickening
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcohol Abuse
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Withdrawal Syndrome
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Antisocial Personality Disorder
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusional State
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Illness Anxiety Disorder
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic Disorder Due to A General Medical Condition
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Self-Injurious Ideation
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device Dislocation
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute Hepatic Failure
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stone
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Colic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Dilatation
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Cirrhosis
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cholecystitis
         subjects affected / exposed
    10 / 2507 (0.40%)
    5 / 2515 (0.20%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    1 / 2507 (0.04%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    2 / 2507 (0.08%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis Alcoholic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hepatic Function Abnormal
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Lesion
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal Failure
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Jaundice
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Portal Hypertension
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Biopsy Pleura
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy Prostate
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Glucose Abnormal
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    3 / 2507 (0.12%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Function Test Increased
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagogastroduodenoscopy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet Count Decreased
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    2 / 2507 (0.08%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Fissure
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns Third Degree
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Vertebral Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Contusion
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Fall
         subjects affected / exposed
    5 / 2507 (0.20%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    1 / 2507 (0.04%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    8 / 2507 (0.32%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hand Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hip Fracture
         subjects affected / exposed
    6 / 2507 (0.24%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patella Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Complication
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Renal Failure
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Complication
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation Pneumonitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    3 / 2507 (0.12%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Spinal Compression Fracture
         subjects affected / exposed
    2 / 2507 (0.08%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    2 / 2507 (0.08%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Thoracic Vertebral Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Arteriovenous Malformation
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Buried Penis Syndrome
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial Fibrillation
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Ventricular Thrombosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic Shock
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiorenal Syndrome
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Palpitations
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Brain Injury
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Brain Oedema
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Carpal Tunnel Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Postural
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Coma
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intercostal Neuralgia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Neuropathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of Consciousness
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral Radiculopathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Encephalopathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroglycopenia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    6 / 2507 (0.24%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    12 / 2507 (0.48%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    4 / 13
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic Anaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Cataract
         subjects affected / exposed
    7 / 2507 (0.28%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Nuclear
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Retinopathy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular Hole
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinopathy Hypertensive
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subretinal Fibrosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    6 / 2507 (0.24%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Tenderness
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fissure
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac Disease
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental Caries
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    4 / 2507 (0.16%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Obstruction
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 2507 (0.08%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Poisoning
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    1 / 2507 (0.04%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    2 / 2507 (0.08%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Angiodysplasia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Necrosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Sphincter Insufficiency
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial Eventration
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Umbilical Hernia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory Bowel Disease
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    7 / 2507 (0.28%)
    9 / 2515 (0.36%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Infarction
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    5 / 2507 (0.20%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Enteritis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Disorder
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Necrosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    3 / 2507 (0.12%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative Gastritis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus of Small Bowel
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    3 / 2507 (0.12%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus Ulcer
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    6 / 2507 (0.24%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyshidrotic Eczema
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity Vasculitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrobiosis Lipoidica Diabeticorum
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Generalised
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Macular
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Lesion
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Epidermal Necrolysis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute Kidney Injury
         subjects affected / exposed
    17 / 2507 (0.68%)
    28 / 2515 (1.11%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 33
         deaths causally related to treatment / all
    3 / 3
    2 / 2
    Calculus Urinary
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    14 / 2507 (0.56%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Diabetic Nephropathy
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End Stage Renal Disease
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iga Nephropathy
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    3 / 2507 (0.12%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy Toxic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prerenal Failure
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Artery Stenosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    12 / 2507 (0.48%)
    12 / 2515 (0.48%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 13
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Renal Impairment
         subjects affected / exposed
    4 / 2507 (0.16%)
    9 / 2515 (0.36%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Basedow's Disease
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty Arthritis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Spasms
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 2507 (0.00%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in Extremity
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia Rheumatica
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Soft Tissue
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    12 / 2507 (0.48%)
    9 / 2515 (0.36%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Bacterial
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis Infective
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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 / 2507 (0.04%)
    0 / 2515 (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
    7 / 2507 (0.28%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Gangrenous
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Cholecystitis Infective
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Tonsillitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Colitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium Difficile Infection
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device Related Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    1 / 2507 (0.04%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Douglas' Abscess
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis Infectious
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter Infection
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Bacteraemia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Pyelonephritis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    7 / 2507 (0.28%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    2 / 2
    0 / 0
    Gastritis Viral
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 2507 (0.24%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Shigella
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Pneumonia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Hepatitis E
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster Infection Neurological
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Dermal Cyst
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Spondylitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    7 / 2507 (0.28%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Intervertebral Discitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    3 / 2507 (0.12%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    8 / 2507 (0.32%)
    6 / 2515 (0.24%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Site Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Myiasis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    4 / 2507 (0.16%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Pancreas Infection
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Parotid Abscess
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    2 / 2507 (0.08%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    5 / 2507 (0.20%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    1 / 1
    2 / 2
    Pharyngeal Abscess
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    68 / 2507 (2.71%)
    72 / 2515 (2.86%)
         occurrences causally related to treatment / all
    0 / 80
    0 / 78
         deaths causally related to treatment / all
    9 / 9
    13 / 13
    Pneumonia Bacterial
         subjects affected / exposed
    1 / 2507 (0.04%)
    5 / 2515 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Pneumonia Klebsiella
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 2507 (0.08%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    0 / 2507 (0.00%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    2 / 2
    Pyuria
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         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
    10 / 2507 (0.40%)
    8 / 2515 (0.32%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    16 / 2507 (0.64%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 7
         deaths causally related to treatment / all
    7 / 7
    2 / 2
    Septic Shock
         subjects affected / exposed
    4 / 2507 (0.16%)
    6 / 2515 (0.24%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    2 / 2
    3 / 3
    Sinusitis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syphilis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    5 / 2507 (0.20%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    14 / 2507 (0.56%)
    9 / 2515 (0.36%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Myocarditis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection
         subjects affected / exposed
    1 / 2507 (0.04%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    1 / 1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cachexia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Decreased Appetite
         subjects affected / exposed
    0 / 2507 (0.00%)
    2 / 2515 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 2507 (0.04%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    7 / 2507 (0.28%)
    8 / 2515 (0.32%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    9 / 2507 (0.36%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketosis
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Metabolic Decompensation
         subjects affected / exposed
    2 / 2507 (0.08%)
    4 / 2515 (0.16%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Retention
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    3 / 2507 (0.12%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    4 / 2507 (0.16%)
    7 / 2515 (0.28%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (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
    5 / 2507 (0.20%)
    5 / 2515 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 2507 (0.00%)
    5 / 2515 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insulin-Requiring Type 2 Diabetes Mellitus
         subjects affected / exposed
    0 / 2507 (0.00%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Disorder
         subjects affected / exposed
    1 / 2507 (0.04%)
    1 / 2515 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    1 / 2507 (0.04%)
    0 / 2515 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    5 / 2507 (0.20%)
    3 / 2515 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Rivaroxaban Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 2507 (2.11%)
    60 / 2515 (2.39%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    53 / 2507 (2.11%)
    60 / 2515 (2.39%)
         occurrences all number
    80
    77

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

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

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

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