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    Clinical Trial Results:
    A Clinical Outcomes Study of Darapladib versus Placebo in Subjects Following Acute Coronary Syndrome to Compare the Incidence of Major Adverse Cardiovascular Events (MACE). (Short title: The Stabilization Of pLaques usIng Darapladib- Thrombolysis In Myocardial Infarction 52 [SOLID-TIMI 52] Trial)

    Summary
    EudraCT number
    		 2009-012581-32
    Trial protocol
    		 GB   DE   BE   ES   NL   SE   DK   HU   CZ   SK   PL   BG   IT  
    Global end of trial date
    24 Apr 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    10 Apr 2015
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SB-480848/033
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01000727
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 866 435-7343,
    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
    10 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to evaluate clinical efficacy of long-term treatment with Darapladib Enteric Coated Tablets, 160 mg (oral once daily dose) as compared with placebo when added to standard of care in an ACS patient population on the incidence of first occurrence of the composite of major coronary events (i.e., CHD death, non-fatal MI, or urgent coronary revascularization for myocardial ischemia).
    Protection of trial subjects
    The secreted isoform of Lp-PLA2 was first identified on the basis of its in vitro ability to degrade platelet-activating factor (PAF); hence, it is also known as PAF-acetylhydrolase (PAF-AH). Although the assertion that Lp-PLA2 degrades PAF in vivo remains unproven, PAF has been implicated in prothrombotic, allergic, and inflammatory responses, suggesting that blocking its degradation in patients may be detrimental. Due to this theoretical concern, participants with severe asthma poorly controlled on pharmacotherapy and participants with a history of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses were excluded from participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 2009
    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
    Denmark: 442
    Country: Number of subjects enrolled
    France: 270
    Country: Number of subjects enrolled
    Germany: 510
    Country: Number of subjects enrolled
    Hungary: 350
    Country: Number of subjects enrolled
    Italy: 229
    Country: Number of subjects enrolled
    Netherlands: 622
    Country: Number of subjects enrolled
    Poland: 1056
    Country: Number of subjects enrolled
    Romania: 246
    Country: Number of subjects enrolled
    Slovakia: 203
    Country: Number of subjects enrolled
    Spain: 166
    Country: Number of subjects enrolled
    Sweden: 157
    Country: Number of subjects enrolled
    United Kingdom: 168
    Country: Number of subjects enrolled
    Belgium: 138
    Country: Number of subjects enrolled
    Bulgaria: 284
    Country: Number of subjects enrolled
    Czech Republic: 443
    Country: Number of subjects enrolled
    Argentina: 159
    Country: Number of subjects enrolled
    Australia: 209
    Country: Number of subjects enrolled
    Brazil: 414
    Country: Number of subjects enrolled
    Canada: 327
    Country: Number of subjects enrolled
    Chile: 155
    Country: Number of subjects enrolled
    China: 445
    Country: Number of subjects enrolled
    Colombia: 172
    Country: Number of subjects enrolled
    India: 345
    Country: Number of subjects enrolled
    Israel: 690
    Country: Number of subjects enrolled
    Japan: 211
    Country: Number of subjects enrolled
    Korea, Republic of: 119
    Country: Number of subjects enrolled
    New Zealand: 121
    Country: Number of subjects enrolled
    Peru: 55
    Country: Number of subjects enrolled
    Philippines: 110
    Country: Number of subjects enrolled
    Russian Federation: 876
    Country: Number of subjects enrolled
    South Africa: 296
    Country: Number of subjects enrolled
    Taiwan: 130
    Country: Number of subjects enrolled
    Thailand: 114
    Country: Number of subjects enrolled
    Turkey: 9
    Country: Number of subjects enrolled
    Ukraine: 306
    Country: Number of subjects enrolled
    United States: 2479
    Worldwide total number of subjects
    13026
    EEA total number of subjects
    5284
    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)
    6794
    From 65 to 84 years
    6101
    85 years and over
    131

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study consisted of a Screening Phase of <=30 days, a Treatment Phase, an End-of-Treatment (EOT) visit, and a Follow-up visit scheduled for 35 +/-7 days after the last study drug intake. The median treatment duration was anticipated to be 3 years.

    Pre-assignment
    Screening details
    		 During the screening phase of the study, participants presenting with acute coronary syndrome (ACS) were randomized within 30 days. Approximately 77% of participants underwent percutaneous coronary intervention (PCI) for the qualifying event.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants were randomized to receive matching placebo once daily.
    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
    dosed once daily with food and swallowed whole (not crushed or chewed)

    Arm title
    		 Darapladib 160 mg
    Arm description
    		 Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.
    Arm type
    		 Experimental

    Investigational medicinal product name
    darapladib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    160 milligram (mg) enteric-coated micronized free base tablet dosed once daily with food and swallowed whole (not crushed or chewed)

    Number of subjects in period 1
    		Placebo Darapladib 160 mg
    Started
    6522
    6504
    Completed
    6347
    6328
    Not completed
    175
    176
         Consent withdrawn by subject
    111
    109
         Lost to follow-up
    41
    43
         Study Closed/Terminated
    23
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo once daily.

    Reporting group title
    Darapladib 160 mg
    Reporting group description
    		 Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

    Reporting group values
    		 Placebo Darapladib 160 mg Total
    Number of subjects
    		 6522 6504 13026
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.3 ± 9.5 64.1 ± 9.52 -
    Gender categorical
    Units: Subjects
        Female
    		 1669 1657 3326
        Male
    		 4853 4847 9700
    Race, customized
    Units: Subjects
        White
    		 5469 5452 10921
        Japanese/East Asian Heritage (EAH)/South EAH(SEAH)
    		 583 574 1157
        Central/South Asian Heritage
    		 200 211 411
        Mixed Asian Heritage
    		 2 3 5
        African American/African Heritage (AH)
    		 160 155 315
        American Indian or Alaska Native (AN)
    		 56 52 108
        American Indian or AN & White
    		 23 31 54
        Native Hawaiian or Other Pacific Islander (OPI)
    		 9 5 14
        African American/AH &American Indian or AN & White
    		 8 5 13
        African American/AH & White
    		 4 5 9
        African American/AH & American Indian or AN
    		 4 4 8
        Asian & White
    		 1 3 4
        Japanese/EAH/SEAH & Native Hawaiian or OPI
    		 1 1 2
        African American/AH & Asian
    		 1 0 1
        African American/AH & Asian & White
    		 1 0 1
        African American/AH & Native Hawaiian or OPI
    		 0 1 1
        American Indian or AN & Native Hawaiian or OPI
    		 0 1 1
        Native Hawaiian or OPI & White
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants were randomized to receive matching placebo once daily.

    Reporting group title
    Darapladib 160 mg
    Reporting group description
    		 Participants were randomized to receive darapladib 160 milligram (mg) enteric-coated tablets once daily.

    Primary: Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (FU) of CV event

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    End point title
    		 Number of participants with first occurrence of any event in the composite of major coronary events (coronary heart disease [CHD] death, non-fatal MI, or urgent coronary revascularization [CR] for MI) during the time period for follow-up (FU) of CV event
    End point description
    CHD death=occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Urgent CR for MI=ischemic discomfort at rest that prompted CR (percutaneous coronary intervention [PCI: any attempt at CR even if not successful] or coronary artery bypass graft) during the same hospitalization or resulted in hospital transfer for the purpose of CR.
    End point type
    Primary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [1]
    6504 [2]
    Units: participants
    910
    903
    Notes
    [1] - All-Randomized Intent-to-Treat (ITT) Population: all randomized participants
    [2] - All-Randomized Intent-to-Treat (ITT) Population: all randomized participants
    Statistical analysis title
    		 Statistical Analysis for Primary Endpoint
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.929 [3]
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1
    Confidence interval
         level
    		 95.02%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.09
    Notes
    [3] - Statistical significance of this p-value is based on the alpha-spending function of this study.

    Secondary: Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [MI] or non-fatal stroke) during the time period for follow-up of CV events

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    End point title
    		 Number of participants with first occurrence of any component of the composite of major adverse cardiovascular events (cardiovascular [CV] death, non-fatal myocardial infarction [MI] or non-fatal stroke) during the time period for follow-up of CV events
    End point description
    CV death=death due to a CV cause, which included but was not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths. Acute MI=evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [4]
    6504 [5]
    Units: participants
    838
    824
    Notes
    [4] - All-Randomized ITT Population
    [5] - All-Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #1
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.777 [6]
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95.02%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.09
    Notes
    [6] - Statistical significance of this p-value is based on the alpha-spending function of this study.

    Secondary: Number of participants with cardiovascular death during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with cardiovascular death during the time period for follow-up of cardiovascular events
    End point description
    CV death is defined as a death due to a CV cause, which includes but is not limited to deaths resulting from stroke, arrhythmia, sudden death (witnessed/unwitnessed), MI, heart failure, pulmonary embolism, peripheral arterial disease, or complications of a CV procedure. Deaths not clearly attributable to non-CV causes are considered to be CV deaths.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [7]
    6504 [8]
    Units: participants
    268
    243
    Notes
    [7] - All Randomized ITT Population
    [8] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #2
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.274
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.08

    Secondary: Number of participants with first occurrence of MI (fatal/non-fatal) during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with first occurrence of MI (fatal/non-fatal) during the time period for follow-up of cardiovascular events
    End point description
    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [9]
    6504 [10]
    Units: participants
    564
    547
    Notes
    [9] - All Randomized ITT Population
    [10] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #3
    Comparison groups
    Darapladib 160 mg v Placebo
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.631
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.09

    Secondary: Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with first occurrence of stroke (fatal/non-fatal) during the time period for follow-up of cardiovascular events
    End point description
    Stroke is defined as the presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [11]
    6504 [12]
    Units: participants
    130
    145
    Notes
    [11] - All Randomized ITT Population
    [12] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #4
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.354
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.42

    Secondary: Number of participants with CHD death during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with CHD death during the time period for follow-up of cardiovascular events
    End point description
    CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [13]
    6504 [14]
    Units: participants
    241
    211
    Notes
    [13] - All-Randomized ITT Population
    [14] - All-Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Enpoint #5
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.161
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.05

    Secondary: Number of participants with urgent coronary revascularization for myocardial ischemia during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with urgent coronary revascularization for myocardial ischemia during the time period for follow-up of cardiovascular events
    End point description
    Urgent coronary revascularization for myocardial ischemia is defined as ischemic discomfort at rest that prompts coronary revascularization (PCI or coronary artery bypass graft [CABG]) during the same hospitalization or resulting in hospital transfer for the purpose of coronary revascularization. PCI is defined as any attempt at revascularization even if not successful (e.g., angioplasty, atherectomy or stenting).
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [15]
    6504 [16]
    Units: participants
    218
    237
    Notes
    [15] - All-Randomized ITT Population
    [16] - All-Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #6
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.31

    Secondary: Number of participants with first occurrence of any event in the composite of total coronary events (CHD death, non-fatal MI, hospitalization for unstable angina, or any coronary revascularization procedure) during the time period for FU of CV events

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    End point title
    		 Number of participants with first occurrence of any event in the composite of total coronary events (CHD death, non-fatal MI, hospitalization for unstable angina, or any coronary revascularization procedure) during the time period for FU of CV events
    End point description
    CHD death, acute MI, and prior MI diagnosed post-randomization are defined in the primary endpoint (major coronary events). Hospitalization for unstable angina=one of the following, but not fulfilling the criteria for MI: ischemic discomfort at rest associated with electrocardiogram (ECG) changes leading to hospitalization; ischemic discomfort at rest regardless of ECG changes leading to hospitalization and revascularization during the same admission; ischemic discomfort at rest in hospital associated with ECG changes; ischemic discomfort at rest in hospital without ECG changes resulting in revascularization during the same admission. NOTE: The event was not considered to be unstable angina if, after invasive/non-invasive testing or other diagnostic testing, the discomfort was found not to be caused by myocardial ischemia. Coronary revascularization procedures exclude PCI planned prior to randomization but performed after randomization.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [17]
    6504 [18]
    Units: participants
    1352
    1290
    Notes
    [17] - All-Randomized ITT Population
    [18] - All-Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #7
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.202
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.03

    Secondary: Number of participants with first occurrence of any coronary revascularization procedures (excluding coronary revascularization planned prior to randomization, but performed after randomization) during the time period for follow-up of cardiovascular event

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    End point title
    		 Number of participants with first occurrence of any coronary revascularization procedures (excluding coronary revascularization planned prior to randomization, but performed after randomization) during the time period for follow-up of cardiovascular event
    End point description
    All coronary revascularization procedures (except for PCI planned prior to randomization but performed after randomization) are included. Examples include coronary artery bypass graft, balloon angioplasty and stenting.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [19]
    6504 [20]
    Units: participants
    967
    926
    Notes
    [19] - All-Randomized ITT Population
    [20] - All-Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #8
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.329
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.05

    Secondary: Number of participants with first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with first occurrence of any component of the composite of all-cause mortality, non-fatal MI, or non-fatal stroke during the time period for follow-up of cardiovascular events
    End point description
    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. Stroke=presence of a new focal neurologic deficit thought to be of vascular origin, with signs/symptoms lasting >24 hours or results in death (in <24 hours).
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [21]
    6504 [22]
    Units: participants
    928
    914
    Notes
    [21] - All Randomized ITT Population
    [22] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #9
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.797
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.08

    Secondary: Number of participants with first occurrence of any event in the composite of CHD death and non-fatal MI during the time period for follow-up of cardiovascular events

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    End point title
    		 Number of participants with first occurrence of any event in the composite of CHD death and non-fatal MI during the time period for follow-up of cardiovascular events
    End point description
    Acute MI is defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Prior MI diagnosed post-randomization (e.g., silent MI)=the development of new pathological Q waves with/without symptoms OR imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischemic cause (pre-event imaging data required for verification of new abnormality), OR pathological findings of a healed/healing MI. CHD death is defined as the occurrence of a fatal MI, death caused by documented cardiac arrest, death resulting from heart failure in a participant with known CHD, death from other forms of acute/chronic CHD, unwitnessed death of unknown origin, or sudden death.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [23]
    6504 [24]
    Units: participants
    725
    701
    Notes
    [23] - All Randomized ITT Population
    [24] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #10
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.546
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.07

    Secondary: Number of participants with all-cause mortality during the time period for vital status

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    End point title
    		 Number of participants with all-cause mortality during the time period for vital status
    End point description
    The number of participants with all-cause mortality was assessed.
    End point type
    Secondary
    End point timeframe
    From randomization until the End-of-Treatment visit or the last date on which endpoints were able to be assessed (up to 3.80 years/average of 2.39 years)
    End point values
    		 Placebo Darapladib 160 mg
    Number of subjects analysed
    6522 [25]
    6504 [26]
    Units: participants
    403
    376
    Notes
    [25] - All Randomized ITT Population
    [26] - All Randomized ITT Population
    Statistical analysis title
    		 Statistical Analysis for Secondary Endpoint #11
    Comparison groups
    Placebo v Darapladib 160 mg
    Number of subjects included in analysis
    13026
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.362
    Method
    		 Cox Proportional Hazard Regression Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Start=Randomization; Stop=The longer of 42 days after last dose of IP/follow-up (FU) visit. "SAEs assessed as related to IP, study participation, or a GSK concomitant medication" and cancer/GI polyps/neoplasms were recorded up to/including any FU contact.
    Adverse event reporting additional description
    SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all randomised participants who received at least one dose of investigational product. Post-randomization AEs have an onset date that is on or after the randomization date.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received matching placebo once daily.

    Reporting group title
    Darapladib
    Reporting group description
    		 Participants received darapladib 160 milligram (mg) enteric-coated tablets once daily.

    Serious adverse events
    		 Placebo Darapladib
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3011 / 6465 (46.57%)
    2933 / 6452 (45.46%)
         number of deaths (all causes)
    403
    376
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute leukaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute myeloid leukaemia
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute promyelocytic leukaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    7 / 6465 (0.11%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoma benign
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenosquamous cell lung cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anal cancer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiocentric lymphoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiosarcoma metastatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    B-cell lymphoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma recurrent
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basal cell carcinoma
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign anorectal neoplasm
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign breast neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastric neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign gastrointestinal neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign laryngeal neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign lung neoplasm
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of adrenal gland
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of bladder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign neoplasm of prostate
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct cancer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cancer
         subjects affected / exposed
    15 / 6465 (0.23%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Bladder cancer recurrent
         subjects affected / exposed
    5 / 6465 (0.08%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder cancer stage 0, with cancer in situ
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder papilloma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder transitional cell carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone giant cell tumour benign
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline ovarian tumour
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain neoplasm malignant
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    8 / 6465 (0.12%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Bronchial carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Central nervous system neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar tumour
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Cervix carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Choroid melanoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Clear cell renal cell carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon adenoma
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    9 / 6465 (0.14%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    1 / 9
    2 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colon cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystadenocarcinoma ovary
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Desmoplastic melanoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse large B-cell lymphoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Essential thrombocythaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibroma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    6 / 6465 (0.09%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    1 / 6
    2 / 7
         deaths causally related to treatment / all
    0 / 2
    1 / 2
    Gastric cancer stage I
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric neoplasm
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal cancer metastatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal stromal cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal stromal tumour
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal tract adenoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma multiforme
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glottis carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cancer metastatic
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatocellular carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large cell lung cancer stage IV
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine benign neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leiomyosarcoma metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Leukaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lip neoplasm malignant stage unspecified
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip squamous cell carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung cancer metastatic
         subjects affected / exposed
    9 / 6465 (0.14%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 7
    0 / 8
    Lung carcinoma cell type unspecified recurrent
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung neoplasm malignant
         subjects affected / exposed
    14 / 6465 (0.22%)
    11 / 6452 (0.17%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 12
         deaths causally related to treatment / all
    0 / 4
    1 / 7
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung squamous cell carcinoma stage I
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoma
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    6 / 6465 (0.09%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Malignant neoplasm of ampulla of Vater
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant neoplasm of unknown primary site
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Malignant neoplasm progression
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Melanoma recurrent
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma benign
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesothelioma malignant
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to bone
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to central nervous system
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to liver
         subjects affected / exposed
    7 / 6465 (0.11%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Metastases to lung
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to lymph nodes
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastases to peritoneum
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to pleura
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases to spine
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic bronchial carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic gastric cancer
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metastatic lymphoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic malignant melanoma
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic neoplasm
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    1 / 2
    Metastatic renal cell carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic squamous cell carcinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic uterine cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myelodysplastic syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myeloproliferative disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neurilemmoma benign
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine carcinoma of the skin
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine tumour
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Non-small cell lung cancer stage IIIB
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-small cell lung cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer recurrent
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Oesophageal carcinoma
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Oral cavity cancer metastatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteosarcoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cancer metastatic
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Ovarian germ cell teratoma benign
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pancreatic carcinoma metastatic
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Paraneoplastic syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Paraproteinaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma cell myeloma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pleomorphic adenoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polycythaemia vera
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Precursor B-lymphoblastic lymphoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate cancer
         subjects affected / exposed
    21 / 6465 (0.32%)
    25 / 6452 (0.39%)
         occurrences causally related to treatment / all
    2 / 21
    2 / 25
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    2 / 6465 (0.03%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    2 / 7
         deaths causally related to treatment / all
    0 / 1
    1 / 3
    Prostate cancer recurrent
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         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 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Rectosigmoid cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    6 / 6465 (0.09%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Renal cell carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cell carcinoma stage II
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal oncocytoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoma metastatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Signet-ring cell carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Skin cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small cell lung cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Small cell lung cancer metastatic
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Small intestine adenocarcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of lung
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the tongue
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    T-cell lymphoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testis cancer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thymoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid cancer metastatic
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue carcinoma stage IV
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tongue neoplasm malignant stage unspecified
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tonsil cancer metastatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tracheal neoplasm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell carcinoma metastatic
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Uterine cancer
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal cancer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated hypertension
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aneurysm
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    11 / 6465 (0.17%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm rupture
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic dissection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    7 / 6465 (0.11%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aortic thrombosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial insufficiency
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Arteriovenous fistula
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coeliac artery occlusion
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    14 / 6465 (0.22%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic microangiopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    0 / 6465 (0.00%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery dissection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery occlusion
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    4 / 6465 (0.06%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemodynamic instability
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypertension
         subjects affected / exposed
    38 / 6465 (0.59%)
    15 / 6452 (0.23%)
         occurrences causally related to treatment / all
    0 / 46
    1 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    19 / 6465 (0.29%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    25 / 6465 (0.39%)
    18 / 6452 (0.28%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery occlusion
         subjects affected / exposed
    3 / 6465 (0.05%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery rupture
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    17 / 6465 (0.26%)
    15 / 6452 (0.23%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche syndrome
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic fistula
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    10 / 6465 (0.15%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    39 / 6465 (0.60%)
    36 / 6452 (0.56%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery dissection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    15 / 6465 (0.23%)
    25 / 6452 (0.39%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral embolism
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    15 / 6465 (0.23%)
    17 / 6452 (0.26%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 20
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    15 / 6465 (0.23%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Polyarteritis nodosa
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post thrombotic syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reperfusion injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal arteritis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicose vein
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular insufficiency
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular occlusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pain
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stenosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasculitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary angioplasty
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery bypass
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Percutaneous coronary intervention
         subjects affected / exposed
    252 / 6465 (3.90%)
    262 / 6452 (4.06%)
         occurrences causally related to treatment / all
    0 / 258
    0 / 279
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Chest discomfort
         subjects affected / exposed
    10 / 6465 (0.15%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    15 / 6465 (0.23%)
    20 / 6452 (0.31%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    36 / 6465 (0.56%)
    34 / 6452 (0.53%)
         occurrences causally related to treatment / all
    0 / 36
    1 / 34
         deaths causally related to treatment / all
    0 / 36
    1 / 34
    Device dislocation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    14 / 6465 (0.22%)
    27 / 6452 (0.42%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug withdrawal syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face oedema
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gait disturbance
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hernia obstructive
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    5 / 6465 (0.08%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammation
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Local swelling
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical device complication
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucosal haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-organ failure
         subjects affected / exposed
    9 / 6465 (0.14%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Nodule
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    298 / 6465 (4.61%)
    248 / 6452 (3.84%)
         occurrences causally related to treatment / all
    1 / 387
    0 / 331
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Patient-device incompatibility
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic mass
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyserositis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pseudopolyp
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Puncture site haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    11 / 6465 (0.17%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent malfunction
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stent-graft endoleak
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    35 / 6465 (0.54%)
    26 / 6452 (0.40%)
         occurrences causally related to treatment / all
    1 / 35
    0 / 26
         deaths causally related to treatment / all
    1 / 35
    0 / 26
    Sudden death
         subjects affected / exposed
    28 / 6465 (0.43%)
    26 / 6452 (0.40%)
         occurrences causally related to treatment / all
    1 / 28
    0 / 26
         deaths causally related to treatment / all
    1 / 28
    0 / 26
    Surgical failure
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Thrombosis in device
         subjects affected / exposed
    8 / 6465 (0.12%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel puncture site thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy to arthropod sting
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic reaction
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic shock
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sarcoidosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Acquired phimosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balanoposthitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign prostatic hyperplasia
         subjects affected / exposed
    12 / 6465 (0.19%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast pain
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical dysplasia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystocele
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial hyperplasia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile dysfunction
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menometrorrhagia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Organic erectile dysfunction
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    5 / 6465 (0.08%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal fistula
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatism
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sperm granuloma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spermatocele
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal prolapse
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    16 / 6465 (0.25%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    1 / 18
    0 / 11
         deaths causally related to treatment / all
    1 / 3
    0 / 3
    Acute respiratory distress syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    10 / 6465 (0.15%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Alveolitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Aspiration
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma late onset
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis chronic
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    45 / 6465 (0.70%)
    56 / 6452 (0.87%)
         occurrences causally related to treatment / all
    1 / 65
    0 / 79
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cough
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    27 / 6465 (0.42%)
    21 / 6452 (0.33%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Dyspnoea exertional
         subjects affected / exposed
    4 / 6465 (0.06%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Epistaxis
         subjects affected / exposed
    13 / 6465 (0.20%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Granulomatous pneumonitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    7 / 6465 (0.11%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemothorax
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    4 / 6465 (0.06%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal oedema
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal congestion
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal septum deviation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    8 / 6465 (0.12%)
    14 / 6452 (0.22%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    5 / 6465 (0.08%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Pneumonitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    6 / 6465 (0.09%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary congestion
         subjects affected / exposed
    9 / 6465 (0.14%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    22 / 6465 (0.34%)
    28 / 6452 (0.43%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 28
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Pulmonary fibrosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    18 / 6465 (0.28%)
    15 / 6452 (0.23%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 16
         deaths causally related to treatment / all
    0 / 5
    0 / 0
    Pulmonary sarcoidosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory arrest
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory depression
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    11 / 6465 (0.17%)
    11 / 6452 (0.17%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 3
    0 / 4
    Sleep apnoea syndrome
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sputum retention
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Affective disorder
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol abuse
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol withdrawal syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    9 / 6465 (0.14%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Confusional state
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    14 / 6465 (0.22%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression suicidal
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug abuse
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emotional distress
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental disorder due to a general medical condition
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    4 / 6465 (0.06%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mood disorder due to a general medical condition
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Psychotic disorder due to a general medical condition
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schizophrenia, undifferentiated type
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Substance abuse
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ammonia increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood bilirubin increased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium decreased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood potassium increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-reactive protein increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac enzymes increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac output decreased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac stress test abnormal
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium test positive
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction decreased
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment depression
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram ST segment elevation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise test abnormal
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibrin D dimer increased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme abnormal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic enzyme increased
         subjects affected / exposed
    8 / 6465 (0.12%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    2 / 8
    4 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laboratory test abnormal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test abnormal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Platelet count increased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary function test decreased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin I increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin T increased
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Troponin increased
         subjects affected / exposed
    16 / 6465 (0.25%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Afferent loop syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 6465 (0.00%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic ulcer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle fracture
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial restenosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod sting
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain contusion
         subjects affected / exposed
    4 / 6465 (0.06%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac function disturbance postoperative
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery restenosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral hyperperfusion syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Comminuted fracture
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compression fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media reaction
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    5 / 6465 (0.08%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery reocclusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    30 / 6465 (0.46%)
    30 / 6452 (0.46%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 34
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis radiation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dural tear
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Excoriation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exposure via inhalation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye penetration
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial bones fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Fat embolism
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    10 / 6465 (0.15%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured ischium
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder postoperative
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun shot wound
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat exhaustion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heat stroke
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    10 / 6465 (0.15%)
    11 / 6452 (0.17%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site pain
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         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
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal anastomosis complication
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 6465 (0.00%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kidney contusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament rupture
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mountain sickness acute
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Muscle rupture
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    4 / 6465 (0.06%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peroneal nerve injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoconiosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural contusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-traumatic pain
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative ileus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpericardiotomy syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Procedural haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural headache
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomeningocele
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    9 / 6465 (0.14%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Scapula fracture
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal haematoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt stenosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shunt thrombosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sternal fracture
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    6 / 6465 (0.09%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Tendon injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon rupture
         subjects affected / exposed
    1 / 6465 (0.02%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    4 / 6465 (0.06%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic shock
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic ulcer
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft complication
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft occlusion
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular graft thrombosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular procedure complication
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    8 / 6465 (0.12%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound necrosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal arteriovenous malformation
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odontogenic cyst
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phimosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    8 / 6465 (0.12%)
    11 / 6452 (0.17%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Acute left ventricular failure
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    446 / 6465 (6.90%)
    432 / 6452 (6.70%)
         occurrences causally related to treatment / all
    3 / 547
    7 / 527
         deaths causally related to treatment / all
    0 / 41
    0 / 26
    Angina pectoris
         subjects affected / exposed
    272 / 6465 (4.21%)
    266 / 6452 (4.12%)
         occurrences causally related to treatment / all
    0 / 319
    1 / 293
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Angina unstable
         subjects affected / exposed
    546 / 6465 (8.45%)
    562 / 6452 (8.71%)
         occurrences causally related to treatment / all
    4 / 704
    5 / 711
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Aortic valve incompetence
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve stenosis
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Arrhythmia supraventricular
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis coronary artery
         subjects affected / exposed
    5 / 6465 (0.08%)
    11 / 6452 (0.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Arteriospasm coronary
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    108 / 6465 (1.67%)
    76 / 6452 (1.18%)
         occurrences causally related to treatment / all
    2 / 129
    0 / 101
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial flutter
         subjects affected / exposed
    14 / 6465 (0.22%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    14 / 6465 (0.22%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    4 / 6465 (0.06%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyarrhythmia
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    9 / 6465 (0.14%)
    21 / 6452 (0.33%)
         occurrences causally related to treatment / all
    0 / 9
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle branch block left
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    18 / 6465 (0.28%)
    29 / 6452 (0.45%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 29
         deaths causally related to treatment / all
    0 / 14
    0 / 23
    Cardiac asthma
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac discomfort
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    176 / 6465 (2.72%)
    170 / 6452 (2.63%)
         occurrences causally related to treatment / all
    2 / 233
    1 / 245
         deaths causally related to treatment / all
    0 / 28
    0 / 25
    Cardiac failure acute
         subjects affected / exposed
    21 / 6465 (0.32%)
    20 / 6452 (0.31%)
         occurrences causally related to treatment / all
    0 / 27
    1 / 35
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Cardiac failure chronic
         subjects affected / exposed
    14 / 6465 (0.22%)
    16 / 6452 (0.25%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 17
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiac failure congestive
         subjects affected / exposed
    101 / 6465 (1.56%)
    107 / 6452 (1.66%)
         occurrences causally related to treatment / all
    2 / 165
    0 / 173
         deaths causally related to treatment / all
    1 / 9
    0 / 9
    Cardiac tamponade
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    9 / 6465 (0.14%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 5
         deaths causally related to treatment / all
    1 / 8
    0 / 5
    Cardiogenic shock
         subjects affected / exposed
    5 / 6465 (0.08%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 8
    Cardiomyopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    1 / 1
    Cardiorenal syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    11 / 6465 (0.17%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 9
    0 / 10
    Cardiovascular insufficiency
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Chronotropic incompetence
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conduction disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery disease
         subjects affected / exposed
    145 / 6465 (2.24%)
    139 / 6452 (2.15%)
         occurrences causally related to treatment / all
    1 / 165
    0 / 149
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Coronary artery dissection
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery occlusion
         subjects affected / exposed
    10 / 6465 (0.15%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    59 / 6465 (0.91%)
    38 / 6452 (0.59%)
         occurrences causally related to treatment / all
    0 / 60
    0 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dilatation ventricular
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive heart disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Interventricular septum rupture
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac thrombus
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    5 / 6465 (0.08%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Left ventricular failure
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Microvascular coronary artery disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    5 / 6465 (0.08%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    61 / 6465 (0.94%)
    45 / 6452 (0.70%)
         occurrences causally related to treatment / all
    0 / 64
    0 / 46
         deaths causally related to treatment / all
    0 / 22
    0 / 17
    Myocardial ischaemia
         subjects affected / exposed
    53 / 6465 (0.82%)
    47 / 6452 (0.73%)
         occurrences causally related to treatment / all
    0 / 56
    0 / 49
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Myocardial rupture
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myopericarditis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal rhythm
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    9 / 6465 (0.14%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paroxysmal arrhythmia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    12 / 6465 (0.19%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuropericarditis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postinfarction angina
         subjects affected / exposed
    8 / 6465 (0.12%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal angina
         subjects affected / exposed
    1 / 6465 (0.02%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restrictive cardiomyopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sick sinus syndrome
         subjects affected / exposed
    10 / 6465 (0.15%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinoatrial block
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus arrhythmia
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus tachycardia
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachyarrhythmia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    11 / 6465 (0.17%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Torsade de pointes
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trifascicular block
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricle rupture
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Ventricular dyssynchrony
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    4 / 6465 (0.06%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    14 / 6465 (0.22%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 13
         deaths causally related to treatment / all
    0 / 8
    0 / 3
    Ventricular tachyarrhythmia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    28 / 6465 (0.43%)
    19 / 6452 (0.29%)
         occurrences causally related to treatment / all
    0 / 33
    1 / 21
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Nervous system disorders
    Aphasia
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basilar migraine
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain injury
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain oedema
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Brain stem stroke
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Carotid arteriosclerosis
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    34 / 6465 (0.53%)
    27 / 6452 (0.42%)
         occurrences causally related to treatment / all
    0 / 37
    1 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid sinus syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carpal tunnel syndrome
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar ataxia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cerebellar infarction
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral arteriosclerosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral artery embolism
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral circulatory failure
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 4
    Cerebral infarction
         subjects affected / exposed
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    16 / 6465 (0.25%)
    19 / 6452 (0.29%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    0 / 4
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular insufficiency
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical myelopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical neuritis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complex regional pain syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    8 / 6465 (0.12%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dementia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer’s type
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic neuropathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    7 / 6465 (0.11%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysaesthesia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    4 / 6465 (0.06%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Encephalopathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frontotemporal dementia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Grand mal convulsion
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Haemorrhagic cerebral infarction
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhagic stroke
         subjects affected / exposed
    10 / 6465 (0.15%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 6
         deaths causally related to treatment / all
    1 / 4
    0 / 5
    Haemorrhagic transformation stroke
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Head discomfort
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    4 / 6465 (0.06%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegic migraine
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperaesthesia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic seizure
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intercostal neuralgia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial aneurysm
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial haematoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cerebral infarction
         subjects affected / exposed
    9 / 6465 (0.14%)
    14 / 6452 (0.22%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    86 / 6465 (1.33%)
    93 / 6452 (1.44%)
         occurrences causally related to treatment / all
    0 / 89
    0 / 101
         deaths causally related to treatment / all
    0 / 9
    0 / 8
    Lacunar infarction
         subjects affected / exposed
    4 / 6465 (0.06%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lumbar radiculopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoparesis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoplegia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Motor neurone disease
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple sclerosis relapse
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Narcolepsy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroglycopenia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathy peripheral
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normal pressure hydrocephalus
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occipital neuralgia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraplegia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paresis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson’s disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral sensory neuropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal paralysis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    12 / 6465 (0.19%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    4 / 6465 (0.06%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensory disturbance
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Simple partial seizures
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Speech disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal epidural haematoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic myelopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    10 / 6465 (0.15%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Syncope
         subjects affected / exposed
    60 / 6465 (0.93%)
    58 / 6452 (0.90%)
         occurrences causally related to treatment / all
    1 / 62
    0 / 62
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thalamic infarction
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient global amnesia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    45 / 6465 (0.70%)
    48 / 6452 (0.74%)
         occurrences causally related to treatment / all
    0 / 51
    1 / 53
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Trigeminal neuralgia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    VIIth nerve paralysis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular encephalopathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral artery occlusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    6 / 6465 (0.09%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo CNS origin
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Agranulocytosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    43 / 6465 (0.67%)
    49 / 6452 (0.76%)
         occurrences causally related to treatment / all
    0 / 47
    1 / 53
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia macrocytic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic anaemia
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Heparin-induced thrombocytopenia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercoagulation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    7 / 6465 (0.11%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy mediastinal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoid tissue hyperplasia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic normocytic anaemia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness neurosensory
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hearing impaired
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden hearing loss
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tinnitus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    8 / 6465 (0.12%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo positional
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Accommodation disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Age-related macular degeneration
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amaurosis fugax
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    4 / 6465 (0.06%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract nuclear
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic retinopathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ectropion
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eyelid cyst
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lens dislocation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular hole
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic neuropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal artery occlusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinoschisis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal adhesions
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal distension
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 6465 (0.02%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    12 / 6465 (0.19%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    2 / 13
    1 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
         subjects affected / exposed
    9 / 6465 (0.14%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal strangulated hernia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abnormal faeces
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic pancreatitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fissure
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal fistula
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett’s oesophagus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brunner’s gland hyperplasia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Caecitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coeliac artery stenosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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 / 6465 (0.02%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ischaemic
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis ulcerative
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colonic pseudo-obstruction
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 6465 (0.03%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn’s disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gastroparesis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic hernia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 6465 (0.12%)
    14 / 6452 (0.22%)
         occurrences causally related to treatment / all
    0 / 8
    2 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 6465 (0.00%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    5 / 6465 (0.08%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal polyp
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer
         subjects affected / exposed
    7 / 6465 (0.11%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenogastric reflux
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    5 / 6465 (0.08%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocele
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovesical fistula
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive oesophagitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral hernia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric haemorrhage
         subjects affected / exposed
    5 / 6465 (0.08%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric perforation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric polyps
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    17 / 6465 (0.26%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    1 / 17
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    16 / 6465 (0.25%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis atrophic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenal ulcer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis haemorrhagic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    26 / 6465 (0.40%)
    18 / 6452 (0.28%)
         occurrences causally related to treatment / all
    0 / 27
    0 / 23
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    13 / 6465 (0.20%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophagitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic erosive gastritis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus hernia
         subjects affected / exposed
    4 / 6465 (0.06%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperchlorhydria
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal stenosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    17 / 6465 (0.26%)
    16 / 6452 (0.25%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia, obstructive
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal infarction
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intestinal obstruction
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal perforation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ulcer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intra-abdominal haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal obstruction
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestinal ulcer
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    8 / 6465 (0.12%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    1 / 10
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    5 / 6465 (0.08%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric artery thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mesenteric vein thrombosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    6 / 6465 (0.09%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction gastric
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal stenosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal ulcer
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic pseudocyst
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    7 / 6465 (0.11%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    1 / 9
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis acute
         subjects affected / exposed
    11 / 6465 (0.17%)
    12 / 6452 (0.19%)
         occurrences causally related to treatment / all
    1 / 14
    1 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatitis chronic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periproctitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal mesothelial hyperplasia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumoperitoneum
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proctitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular cyst
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal fissure
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    9 / 6465 (0.14%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal ulcer haemorrhage
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reflux gastritis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haematoma
         subjects affected / exposed
    1 / 6465 (0.02%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Short-bowel syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    7 / 6465 (0.11%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal perforation
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestine polyp
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical hernia, obstructive
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    8 / 6465 (0.12%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Uraemic gastropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    6 / 6465 (0.09%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Alcoholic liver disease
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct obstruction
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyskinesia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis
         subjects affected / exposed
    13 / 6465 (0.20%)
    10 / 6452 (0.15%)
         occurrences causally related to treatment / all
    1 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    15 / 6465 (0.23%)
    15 / 6452 (0.23%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    18 / 6465 (0.28%)
    23 / 6452 (0.36%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholestasis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    3 / 6465 (0.05%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    2 / 3
    4 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cyst
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    0 / 6465 (0.00%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic function abnormal
         subjects affected / exposed
    5 / 6465 (0.08%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis alcoholic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis cholestatic
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis toxic
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatorenal syndrome
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatotoxicity
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Liver injury
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    3 / 6465 (0.05%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    8 / 6465 (0.12%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ulcer
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry gangrene
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pemphigus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photosensitivity reaction
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriasis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rosacea
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin erosion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    7 / 6465 (0.11%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stasis dermatitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute prerenal failure
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Azotaemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder outlet obstruction
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder stenosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus ureteric
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urethral
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus urinary
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis haemorrhagic
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic nephropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    13 / 6465 (0.20%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemorrhage urinary tract
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive nephropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Micturition disorder
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephritis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    9 / 6465 (0.14%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyuria
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery arteriosclerosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery occlusion
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal artery stenosis
         subjects affected / exposed
    3 / 6465 (0.05%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    2 / 6465 (0.03%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure
         subjects affected / exposed
    19 / 6465 (0.29%)
    20 / 6452 (0.31%)
         occurrences causally related to treatment / all
    1 / 20
    0 / 20
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Renal failure acute
         subjects affected / exposed
    46 / 6465 (0.71%)
    44 / 6452 (0.68%)
         occurrences causally related to treatment / all
    2 / 48
    1 / 48
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Renal failure chronic
         subjects affected / exposed
    5 / 6465 (0.08%)
    16 / 6452 (0.25%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 17
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal hypertension
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    5 / 6465 (0.08%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal infarct
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal tubular necrosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress urinary incontinence
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric dilatation
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    8 / 6465 (0.12%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinoma
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune thyroiditis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Primary hypothyroidism
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing spondylitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    6 / 6465 (0.09%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back pain
         subjects affected / exposed
    10 / 6465 (0.15%)
    8 / 6452 (0.12%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical spinal stenosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Compartment syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flank pain
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture malunion
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture nonunion
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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 / 6465 (0.02%)
    0 / 6452 (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
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    11 / 6465 (0.17%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint instability
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb discomfort
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle disorder
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle haemorrhage
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle spasms
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    21 / 6465 (0.32%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    6 / 6465 (0.09%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    3 / 6465 (0.05%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck pain
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    40 / 6465 (0.62%)
    29 / 6452 (0.45%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondritis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in extremity
         subjects affected / exposed
    3 / 6465 (0.05%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain in jaw
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plantar fascial fibromatosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyositis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic arthropathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    3 / 6465 (0.05%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sensation of heaviness
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sjogren’s syndrome
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal column stenosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    1 / 6465 (0.02%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal pain
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondyloarthropathy
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolysis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sympathetic posterior cervical syndrome
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial cyst
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall abscess
         subjects affected / exposed
    3 / 6465 (0.05%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess intestinal
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    6 / 6465 (0.09%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acarodermatitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    6 / 6465 (0.09%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    8 / 6465 (0.12%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis perforated
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis bacterial
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial prostatitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    19 / 6465 (0.29%)
    29 / 6452 (0.45%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    10 / 6465 (0.15%)
    9 / 6452 (0.14%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Burkholderia pseudomallei infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bursitis infective
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    24 / 6465 (0.37%)
    27 / 6452 (0.42%)
         occurrences causally related to treatment / all
    0 / 29
    0 / 30
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis staphylococcal
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis suppurative
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis infective
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    7 / 6465 (0.11%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Creutzfeldt-Jakob disease
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cystitis
         subjects affected / exposed
    6 / 6465 (0.09%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    16 / 6465 (0.25%)
    14 / 6452 (0.22%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema infected
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Endocarditis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis enterococcal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis infectious
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder empyema
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gangrene
         subjects affected / exposed
    8 / 6465 (0.12%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    20 / 6465 (0.31%)
    18 / 6452 (0.28%)
         occurrences causally related to treatment / all
    1 / 21
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin infection
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis E
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis infectious mononucleosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected lymphocele
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    4 / 6465 (0.06%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Influenza
         subjects affected / exposed
    4 / 6465 (0.06%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    4 / 6465 (0.06%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 6465 (0.03%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphangitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis tuberculous
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroborreliosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orchitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis chronic
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis tuberculous
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    113 / 6465 (1.75%)
    130 / 6452 (2.01%)
         occurrences causally related to treatment / all
    0 / 124
    0 / 139
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Pneumonia bacterial
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia fungal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia legionella
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia pseudomonas aeruginosa
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural pneumonia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative abscess
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pseudomembranous colitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonas infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary sepsis
         subjects affected / exposed
    1 / 6465 (0.02%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    5 / 6465 (0.08%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyoderma streptococcal
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    5 / 6465 (0.08%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection bacterial
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    23 / 6465 (0.36%)
    24 / 6452 (0.37%)
         occurrences causally related to treatment / all
    1 / 23
    0 / 25
         deaths causally related to treatment / all
    1 / 5
    0 / 9
    Septic shock
         subjects affected / exposed
    9 / 6465 (0.14%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 6
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Sinusitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin bacterial infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Staphylococcal sepsis
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subcutaneous abscess
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular abscess
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (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
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 6465 (0.02%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    6 / 6465 (0.09%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    47 / 6465 (0.73%)
    25 / 6452 (0.39%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    2 / 6465 (0.03%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    6 / 6465 (0.09%)
    7 / 6452 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    2 / 6465 (0.03%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    4 / 6465 (0.06%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    5 / 6465 (0.08%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection pseudomonas
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection staphylococcal
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound sepsis
         subjects affected / exposed
    0 / 6465 (0.00%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    18 / 6465 (0.28%)
    19 / 6452 (0.29%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    19 / 6465 (0.29%)
    17 / 6452 (0.26%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    3 / 6465 (0.05%)
    4 / 6452 (0.06%)
         occurrences causally related to treatment / all
    1 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         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
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    3 / 6465 (0.05%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydraemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    5 / 6465 (0.08%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    4 / 6465 (0.06%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hyperlipidaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    11 / 6465 (0.17%)
    13 / 6452 (0.20%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hypokalaemia
         subjects affected / exposed
    7 / 6465 (0.11%)
    5 / 6452 (0.08%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    10 / 6465 (0.15%)
    6 / 6452 (0.09%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    2 / 6465 (0.03%)
    3 / 6452 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insulin-requiring type 2 diabetes mellitus
         subjects affected / exposed
    1 / 6465 (0.02%)
    0 / 6452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    2 / 6465 (0.03%)
    2 / 6452 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 6465 (0.00%)
    1 / 6452 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    21 / 6465 (0.32%)
    21 / 6452 (0.33%)
         occurrences causally related to treatment / all
    1 / 21
    2 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Darapladib
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3416 / 6465 (52.84%)
    3698 / 6452 (57.32%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    409 / 6465 (6.33%)
    370 / 6452 (5.73%)
         occurrences all number
    458
    414
    Hypotension
         subjects affected / exposed
    132 / 6465 (2.04%)
    154 / 6452 (2.39%)
         occurrences all number
    139
    163
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    398 / 6465 (6.16%)
    363 / 6452 (5.63%)
         occurrences all number
    474
    433
    Atrial fibrillation
         subjects affected / exposed
    185 / 6465 (2.86%)
    154 / 6452 (2.39%)
         occurrences all number
    213
    183
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    357 / 6465 (5.52%)
    354 / 6452 (5.49%)
         occurrences all number
    398
    414
    Headache
         subjects affected / exposed
    202 / 6465 (3.12%)
    175 / 6452 (2.71%)
         occurrences all number
    220
    198
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    187 / 6465 (2.89%)
    184 / 6452 (2.85%)
         occurrences all number
    195
    195
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    111 / 6465 (1.72%)
    134 / 6452 (2.08%)
         occurrences all number
    123
    153
    Fatigue
         subjects affected / exposed
    334 / 6465 (5.17%)
    302 / 6452 (4.68%)
         occurrences all number
    354
    318
    Non-cardiac chest pain
         subjects affected / exposed
    431 / 6465 (6.67%)
    414 / 6452 (6.42%)
         occurrences all number
    499
    476
    Oedema peripheral
         subjects affected / exposed
    245 / 6465 (3.79%)
    239 / 6452 (3.70%)
         occurrences all number
    274
    267
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    130 / 6465 (2.01%)
    140 / 6452 (2.17%)
         occurrences all number
    140
    157
    Abdominal pain upper
         subjects affected / exposed
    128 / 6465 (1.98%)
    135 / 6452 (2.09%)
         occurrences all number
    137
    145
    Abnormal faeces
         subjects affected / exposed
    64 / 6465 (0.99%)
    525 / 6452 (8.14%)
         occurrences all number
    64
    551
    Constipation
         subjects affected / exposed
    174 / 6465 (2.69%)
    165 / 6452 (2.56%)
         occurrences all number
    177
    175
    Diarrhoea
         subjects affected / exposed
    351 / 6465 (5.43%)
    675 / 6452 (10.46%)
         occurrences all number
    386
    826
    Dyspepsia
         subjects affected / exposed
    116 / 6465 (1.79%)
    130 / 6452 (2.01%)
         occurrences all number
    123
    139
    Large intestine polyp
         subjects affected / exposed
    130 / 6465 (2.01%)
    127 / 6452 (1.97%)
         occurrences all number
    139
    145
    Nausea
         subjects affected / exposed
    176 / 6465 (2.72%)
    198 / 6452 (3.07%)
         occurrences all number
    194
    219
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    355 / 6465 (5.49%)
    324 / 6452 (5.02%)
         occurrences all number
    382
    350
    Dyspnoea
         subjects affected / exposed
    310 / 6465 (4.80%)
    286 / 6452 (4.43%)
         occurrences all number
    342
    307
    Skin and subcutaneous tissue disorders
    Skin odour abnormal
         subjects affected / exposed
    23 / 6465 (0.36%)
    241 / 6452 (3.74%)
         occurrences all number
    23
    267
    Renal and urinary disorders
    Urine odour abnormal
         subjects affected / exposed
    65 / 6465 (1.01%)
    344 / 6452 (5.33%)
         occurrences all number
    65
    353
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    207 / 6465 (3.20%)
    158 / 6452 (2.45%)
         occurrences all number
    225
    175
    Back pain
         subjects affected / exposed
    262 / 6465 (4.05%)
    224 / 6452 (3.47%)
         occurrences all number
    287
    243
    Musculoskeletal pain
         subjects affected / exposed
    130 / 6465 (2.01%)
    98 / 6452 (1.52%)
         occurrences all number
    139
    102
    Myalgia
         subjects affected / exposed
    186 / 6465 (2.88%)
    215 / 6452 (3.33%)
         occurrences all number
    203
    231
    Pain in extremity
         subjects affected / exposed
    221 / 6465 (3.42%)
    181 / 6452 (2.81%)
         occurrences all number
    236
    197
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    178 / 6465 (2.75%)
    192 / 6452 (2.98%)
         occurrences all number
    214
    212
    Influenza
         subjects affected / exposed
    143 / 6465 (2.21%)
    141 / 6452 (2.19%)
         occurrences all number
    159
    159
    Nasopharyngitis
         subjects affected / exposed
    279 / 6465 (4.32%)
    273 / 6452 (4.23%)
         occurrences all number
    344
    352
    Upper respiratory tract infection
         subjects affected / exposed
    144 / 6465 (2.23%)
    162 / 6452 (2.51%)
         occurrences all number
    163
    191
    Urinary tract infection
         subjects affected / exposed
    205 / 6465 (3.17%)
    157 / 6452 (2.43%)
         occurrences all number
    253
    196
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    358 / 6465 (5.54%)
    325 / 6452 (5.04%)
         occurrences all number
    373
    340

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2010
    The primary intent was to revise two exclusion criteria. 1. The definition of liver disease was revised to remove AST from the list of required liver function tests, and participants (par.) with chronic stable hepatitis were allowed to be enrolled under certain circumstances. RATIONALE: AST was removed from the list of required liver function assessments during the screening phase to assess eligibility because the ALT assessment is much more specific for evaluating liver function abnormalities. 2. The threshold for excluding par. of Japanese, Chinese, or Korean ancestry with plasma levels of Lp-PLA2 activity was revised from <=10 to <=20.0 nmol/min/mL. RATIONALE: The original text excluded Japanese, Chinese, and Korean par. with plasma Lp-PLA2 activity <=10 nmol/min/mL prior to randomization. This threshold was intended to be a surrogate measure for being homozygous for the 279F null variant allele, predominantly found in East Asians, and was listed as an exclusion criterion to avoid randomizing par. who would not be expected to produce circulating levels of the Lp-PLA2 enzyme. As par. who were homozygous for the 279F null allele would have no Lp-PLA2 enzyme to inhibit, it was important to identify these par. since there would be no clear rationale for exposing such par. to the investigational Lp-PLA2 inhibitor darapladib. Data from par. with chronic coronary heart disease in the STABILITY study (Study LPL100601) determined that Japanese, Chinese, and Korean par. who were homozygous for the 279F variant had reported baseline plasma Lp-PLA2 activity levels approaching 20.0 nmol/min/mL when measured by the assay used in this study. The text for the exclusion criterion pertaining to Japanese, Chinese, and Korean par. revised the threshold for the plasma Lp-PLA2 activity to <=20.0 nmol/min/mL prior to randomization, which was expected to help ensure that Japanese, Chinese, and Korean par. who were homozygous for the 279F variant were not enrolled.
    26 Apr 2012
    The primary intent of this amendment was to allow the Follow-up visit to be conducted by telephone in participants who met pre-defined criteria. RATIONALE: This change allowed collection of study endpoints/safety data in participants unable to attend a Follow-up clinic visit.
    22 Oct 2012
    The primary intent was to allow increased collection of data on new cancer, recurrence of cancer, or progression of cancer; and adjudication of all gastrointestinal (GI) neoplasms (malignant and benign) and all GI polyps (malignant, and benign, and non-neoplastic). RATIONALE: Darapladib was given by oral gavage to male and female rodents starting from before sexual maturation and continuing every day throughout their lifetime for up to 2 years. Data from these studies became available prior to the end of the study. Overall, the data suggested drug-related increases in the incidence of adenomas and/or adenocarcinomas of the jejunum in male mice and male rats given higher doses of darapladib. The Independent Data Monitoring Committee for both this study and the other Phase III study (Study LPL100601) reviewed these data and re-reviewed the safety data, including reports of tumors in study participants. Following this review, the IDMC recommended that the trials continue without any changes. However, this protocol change was proposed and incorporated by the sponsor to allow a more thorough review of neoplasms reported in this study.
    29 Nov 2012
    This country-specific amendment for France was required by the French regulatory authority (ANSM). The amendment required participants diagnosed with inflammatory bowel disease (Crohn’s disease or ulcerative colitis) be immediately discontinued from investigational product (IP).
    26 Feb 2014
    The primary reason for this amendment was to change the primary efficacy endpoint from Major Adverse Cardiovascular Events (MACE: cardiovascular death, non-fatal MI, or non-fatal stroke) to the previous secondary endpoint of Major Coronary Events (i.e., CHD death, non-fatal MI, or urgent coronary revascularization for myocardial ischemia). RATIONALE: The Executive Steering Committee of the SOLID-TIMI-52 trial (Study SB-480848/033) which was ongoing at that time met to review data from the STABILITY (Study LPL100601) trial (similar design as Study SB-480848/033, except in a chronic CHD population) and made the recommendation to GSK that the primary endpoint of the SOLID-TIMI-52 trial (Study SB-480848/033) be revised to Major Coronary Events (CHD death, non-fatal myocardial infarction, and urgent coronary revascularization for myocardial ischemia) from MACE (CV death, non-fatal myocardial infarction, and non-fatal stroke). Specifically, this change primarily removed both fatal and non-fatal stroke from the composite endpoint. In addition, data from genetic studies and epidemiologic data showed a lack of association between Lp-PLA2 activity and risk of stroke. The decision by GSK to follow the Executive Steering Committee’s recommendation to amend the primary endpoint of the SOLID-TIMI 52 study was made prior to unblinding study data and without communication from the IDMC.

    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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