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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

    Summary
    EudraCT number
    		 2011-005698-21
    Trial protocol
    		 GB   SE   BE   NO   EE   LT   HU   ES   CZ   LV   DE   IT   BG   FI   AT   PT   DK   NL   PL   SK   SI   HR   GR  
    Global end of trial date
    23 Jan 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2019
    First version publication date
    07 Feb 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC11570
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01663402
    WHO universal trial number (UTN)
    		 U1111-1127-4323
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Feb 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jan 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in subjects who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were treated with evidence-based medical and dietary management of dyslipidemia.
    Protection of trial subjects
    Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other Lipid-Modifying Therapy (LMT) as clinically indicated.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Oct 2012
    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
    Georgia: 131
    Country: Number of subjects enrolled
    Guatemala: 25
    Country: Number of subjects enrolled
    Hong Kong: 17
    Country: Number of subjects enrolled
    Argentina: 592
    Country: Number of subjects enrolled
    Australia: 216
    Country: Number of subjects enrolled
    Bosnia and Herzegovina: 155
    Country: Number of subjects enrolled
    Brazil: 928
    Country: Number of subjects enrolled
    Canada: 361
    Country: Number of subjects enrolled
    Chile: 132
    Country: Number of subjects enrolled
    China: 614
    Country: Number of subjects enrolled
    Colombia: 354
    Country: Number of subjects enrolled
    India: 521
    Country: Number of subjects enrolled
    Israel: 582
    Country: Number of subjects enrolled
    Japan: 204
    Country: Number of subjects enrolled
    Korea, Republic of: 94
    Country: Number of subjects enrolled
    Macedonia, the former Yugoslav Republic of: 132
    Country: Number of subjects enrolled
    Malaysia: 110
    Country: Number of subjects enrolled
    Mexico: 349
    Country: Number of subjects enrolled
    New Zealand: 257
    Country: Number of subjects enrolled
    Peru: 208
    Country: Number of subjects enrolled
    Philippines: 116
    Country: Number of subjects enrolled
    Russian Federation: 1109
    Country: Number of subjects enrolled
    Serbia: 255
    Country: Number of subjects enrolled
    Singapore: 49
    Country: Number of subjects enrolled
    South Africa: 505
    Country: Number of subjects enrolled
    Sri Lanka: 314
    Country: Number of subjects enrolled
    Switzerland: 88
    Country: Number of subjects enrolled
    Taiwan: 93
    Country: Number of subjects enrolled
    Thailand: 161
    Country: Number of subjects enrolled
    Turkey: 78
    Country: Number of subjects enrolled
    Ukraine: 639
    Country: Number of subjects enrolled
    United States: 2510
    Country: Number of subjects enrolled
    Netherlands: 686
    Country: Number of subjects enrolled
    Norway: 97
    Country: Number of subjects enrolled
    Poland: 926
    Country: Number of subjects enrolled
    Portugal: 174
    Country: Number of subjects enrolled
    Romania: 145
    Country: Number of subjects enrolled
    Slovakia: 340
    Country: Number of subjects enrolled
    Slovenia: 36
    Country: Number of subjects enrolled
    Spain: 826
    Country: Number of subjects enrolled
    Sweden: 250
    Country: Number of subjects enrolled
    United Kingdom: 292
    Country: Number of subjects enrolled
    Croatia: 69
    Country: Number of subjects enrolled
    Austria: 58
    Country: Number of subjects enrolled
    Belgium: 197
    Country: Number of subjects enrolled
    Bulgaria: 333
    Country: Number of subjects enrolled
    Czech Republic: 381
    Country: Number of subjects enrolled
    Denmark: 352
    Country: Number of subjects enrolled
    Estonia: 216
    Country: Number of subjects enrolled
    Finland: 116
    Country: Number of subjects enrolled
    France: 185
    Country: Number of subjects enrolled
    Germany: 509
    Country: Number of subjects enrolled
    Greece: 70
    Country: Number of subjects enrolled
    Hungary: 224
    Country: Number of subjects enrolled
    Italy: 275
    Country: Number of subjects enrolled
    Latvia: 80
    Country: Number of subjects enrolled
    Lithuania: 188
    Worldwide total number of subjects
    18924
    EEA total number of subjects
    7025
    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)
    13840
    From 65 to 84 years
    5042
    85 years and over
    42

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 1387 sites in 57 countries. Of these, 1328 active sites randomized at least 1 subject. Overall, 35,437 subjects were screened between 11 October 2012 and 17 Jan 2017; of whom 16,513 were screen failures. Screen failures were mainly due to exclusion criteria met.

    Pre-assignment
    Screening details
    		 Randomization was stratified according to country. Assignment to treatment arms was done centrally using an Interactive Voice/Web Response System in a 1:1 ratio (alirocumab: placebo), with permuted-block randomization.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

    Arm title
    		 Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Arm description
    		 Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For subjects receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For subjects receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Alirocumab
    Investigational medicinal product code
    SAR236553, REGN727
    Other name
    Praluent®
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

    Number of subjects in period 1
    		Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Started
    9462
    9462
    Treated
    9443
    9451
    Completed
    7947
    7378
    Not completed
    1515
    2084
         Participant moved
    139
    104
         Other than specified above
    172
    147
         Physician decision
    77
    62
         Consent withdrawn by subject
    118
    91
         Adverse Event
    347
    362
         Randomized but not treated
    19
    11
         Site terminated by sponsor
    1
    3
         Poor compliance to protocol
    529
    454
         Lost to follow-up
    17
    15
         Related to study drug administration
    96
    105
         Two consecutive LDL-C <15 mg/dL
    -
    730

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

    Reporting group title
    Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Reporting group description
    		 Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For subjects receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For subjects receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).

    Reporting group values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W Total
    Number of subjects
    		 9462 9462 18924
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.6 ( 9.4 ) 58.5 ( 9.3 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2372 2390 4762
        Male
    		 7090 7072 14162
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 1555 1581 3136
        Not Hispanic or Latino
    		 7721 7700 15421
        Unknown or Not Reported
    		 186 181 367

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

    Reporting group title
    Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Reporting group description
    		 Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For subjects receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For subjects receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).

    Primary: Time to First Occurrence of Major Adverse Cardiovascular Event (MACE): Coronary Heart Disease Death, Non-Fatal Myocardial Infarction, Fatal and Non-Fatal Ischemic Stroke, or Unstable Angina Requiring Hospitalization

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    End point title
    		 Time to First Occurrence of Major Adverse Cardiovascular Event (MACE): Coronary Heart Disease Death, Non-Fatal Myocardial Infarction, Fatal and Non-Fatal Ischemic Stroke, or Unstable Angina Requiring Hospitalization
    End point description
    All MACE positively adjudicated by Clinical Events Committee (CEC) in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of CHD death, non-fatal MI, fatal and non-fatal ischemic stroke, or unstable angina requiring hospitalization. Percentage of observed subjects with endpoint events were reported. Analysis was performed on Intent-to-treat (ITT) population which included all randomized subjects.
    End point type
    Primary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    11.1
    9.5
    Statistical analysis title
    		 MACE: Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world).
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [1]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 0.93
    Notes
    [1] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to First Occurrence of Any Coronary Heart Disease (CHD) Event: Any CHD Death, Non-Fatal Myocardial Infarction, Unstable Angina Requiring Hospitalization, Ischemia-Driven Coronary Revascularization Procedure

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    End point title
    		 Time to First Occurrence of Any Coronary Heart Disease (CHD) Event: Any CHD Death, Non-Fatal Myocardial Infarction, Unstable Angina Requiring Hospitalization, Ischemia-Driven Coronary Revascularization Procedure
    End point description
    All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death, non-fatal MI, unstable angina requiring hospitalization, or ischemia-driven coronary revascularization procedure. Percentage of observed subjects with endpoint events were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    14.3
    12.7
    Statistical analysis title
    		 Any CHD Event: Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region(North America,South America,Western Europe,Eastern Europe,Asia, Rest of the world).A hierarchical testing approach was used to control the overall type-I error at 0.0249 one-sided alpha level(0.0498 two-sided).Testing was then performed sequentially in the order endpoints were reported.Hierarchical testing sequence continued only if the previous endpoint was statistically significant.
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013 [2]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 0.95
    Notes
    [2] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to First Occurrence of Any Major Coronary Heart Disease (CHD) Event: Any CHD Death and Non-Fatal Myocardial Infarction

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    End point title
    		 Time to First Occurrence of Any Major Coronary Heart Disease (CHD) Event: Any CHD Death and Non-Fatal Myocardial Infarction
    End point description
    All CHD events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CHD endpoint comprised of any CHD death and non-fatal MI. Percentage of observed subjects with endpoint events were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    9.5
    8.4
    Statistical analysis title
    		 Any Major CHD Event: Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing was performed according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006 [3]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 0.96
    Notes
    [3] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to First Occurrence of any Cardiovascular (CV) Event: Any Non-Fatal Coronary Heart Disease Event, Any CV Death, and Non-Fatal Ischemic Stroke

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    End point title
    		 Time to First Occurrence of any Cardiovascular (CV) Event: Any Non-Fatal Coronary Heart Disease Event, Any CV Death, and Non-Fatal Ischemic Stroke
    End point description
    All CV events positively adjudicated by CEC in a blinded fashion, were used in the analysis of the composite CV endpoint comprised of any non-fatal CHD event, any CV death and non-fatal ischemic stroke. Percentage of observed subjects with endpoint events were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    15.6
    13.7
    Statistical analysis title
    		 Any CV Event: Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [4]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 0.94
    Notes
    [4] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke

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    End point title
    		 Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke
    End point description
    All-cause mortality, non-fatal MI and non-fatal ischemic stroke positively adjudicated by CEC in a blinded fashion, were used in the analysis of this endpoint. Percentage of observed subjects with endpoint events were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    11.9
    10.3
    Statistical analysis title
    		 Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0003 [5]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 0.93
    Notes
    [5] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to Coronary Heart Disease Death

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    End point title
    		 Time to Coronary Heart Disease Death
    End point description
    Percentage of observed subjects with CHD death (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    2.3
    2.2
    Statistical analysis title
    		 CHD Death: Placebo vs Alirocumab
    Statistical analysis description
    Analysis was performed using Cox proportional hazard model and log rank test stratified on geographical region (North America, South America, Western Europe, Eastern Europe, Asia, Rest of the world). Testing according to the hierarchical testing procedure (continued only if the previous endpoint was statistically significant).
    Comparison groups
    Placebo v Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects included in analysis
    18924
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3824 [6]
    Method
    		 Logrank
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.11
    Notes
    [6] - Threshold for statistical significance at 0.0498 level.

    Secondary: Time to Cardiovascular Death

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    End point title
    		 Time to Cardiovascular Death
    End point description
    Percentage of observed subjects with CV death (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    2.9
    2.5
    No statistical analyses for this end point

    Secondary: Time to All-Cause Death

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    End point title
    		 Time to All-Cause Death
    End point description
    Percentage of observed subjects with all-cause death (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    4.1
    3.5
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Any Non-Fatal Myocardial Infarction

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    End point title
    		 Time to First Occurrence of Any Non-Fatal Myocardial Infarction
    End point description
    Percentage of observed subjects with any non-fatal MI (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    7.6
    6.6
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke

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    End point title
    		 Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke
    End point description
    Percentage of observed subjects with any non-fatal ischemic stroke (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    1.6
    1.2
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of any Unstable Angina Requiring Hospitalization

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    End point title
    		 Time to First Occurrence of any Unstable Angina Requiring Hospitalization
    End point description
    Percentage of observed subjects with any UA requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    0.6
    0.4
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure

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    End point title
    		 Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure
    End point description
    Percentage of observed subjects with any ischemia-driven coronary revascularization procedure (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    8.8
    7.7
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization

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    End point title
    		 Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization
    End point description
    Percentage of observed subjects with any CHF requiring hospitalization (positively adjudicated by CEC in a blinded fashion) were reported. Analysis was performed on ITT population.
    End point type
    Secondary
    End point timeframe
    From randomization up to 64 months
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: percentage of subjects
        number (not applicable)
    1.9
    1.9
    No statistical analyses for this end point

    Other pre-specified: Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis

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    End point title
    		 Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: ITT Analysis
    End point description
    Adjusted means and standard errors at Month 4, 12 and 48 from multiple imputation approach (to account for missing data) followed by analyses of covariance (ANCOVA) model with the fixed categorical effect of treatment group and the continuous fixed covariate of baseline LDL-C value, including all available post-baseline data from Month 1 up to Month 48 regardless of status on- or off-treatment. Analysis was performed on ITT population. Here, 'n' signifies number of subjects with the parameter measured and baseline measure available for each time-point, for each arm respectively. A multiple approach was used to account for subjects with missing data.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Months 4, 12 and 48
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9462
    9462
    Units: Percent change
    least squares mean (standard error)
        Month 4 (n= 8750, 8602)
    4.4 ( 0.3 )
    -55.8 ( 0.3 )
        Month 12 (n= 8397, 8336)
    8.0 ( 0.4 )
    -45.7 ( 0.4 )
        Month 48 (n= 790, 812)
    16.4 ( 1.8 )
    -23.5 ( 1.6 )
    No statistical analyses for this end point

    Other pre-specified: Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis

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    End point title
    		 Percent Change From Baseline in Calculated LDL-C at Months 4, 12, and 48: On-Treatment Analysis
    End point description
    Adjusted Least-squares (LS) means and standard errors at Month 4, 12 and 48 were obtained from a mixed-effect model with repeated measures (MMRM) including available post-baseline on-treatment data from Month 1 up to Month 48 (i.e. up to 21 days after last injection). Analysis was performed on randomized and treated population. Here, 'n' signifies number of subjects evaluable for this endpoint at specified time points, for each arm respectively.
    End point type
    Other pre-specified
    End point timeframe
    Baseline, Months 4, 12 and 48
    End point values
    		 Placebo Alirocumab 75 mg Q2W/Up to 150 mg Q2W
    Number of subjects analysed
    9443
    9451
    Units: Percent change
    least squares mean (standard error)
        Month 4 (n= 8647, 8486)
    4.4 ( 0.3 )
    -58.3 ( 0.3 )
        Month 12 (n= 8183, 7727)
    8.2 ( 0.4 )
    -52.8 ( 0.4 )
        Month 48 (n= 726, 647)
    14.6 ( 1.0 )
    -40.1 ( 1.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AEs) were collected from signature of the informed consent form until the end of study (Month 64) regardless of seriousness or relationship to Investigational Medicinal Product (IMP).
    Adverse event reporting additional description
    Reported AEs are treatment-emergent AEs that is AEs that developed/worsened during the ‘treatment-emergent period’ (the time from the first dose of study drug up to the last dose of study drug +70 days). Safety population included randomized subjects who actually received at least 1 dose or part of a dose of the double-blind IMP injection.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (for alirocumab) SC injection Q2W added to stable LMT for up to 64 months.

    Reporting group title
    Alirocumab
    Reporting group description
    		 Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when LDL-C levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For subjects receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For subjects receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).

    Serious adverse events
    		 Placebo Alirocumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2350 / 9443 (24.89%)
    2202 / 9451 (23.30%)
         number of deaths (all causes)
    278
    238
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Lymphocytic Leukaemia
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myeloid Leukaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Adenocarcinoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma Gastric
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Adenocarcinoma Of Colon
         subjects affected / exposed
    14 / 9443 (0.15%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adrenal Adenoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenal Neoplasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Cancer Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaplastic Large Cell Lymphoma T- And Null-Cell Types
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Lymphoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-Cell Small Lymphocytic Lymphoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    14 / 9443 (0.15%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Ovarian Tumour
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Salivary Gland Neoplasm
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer Stage Iv
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder Neoplasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Papilloma
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma
         subjects affected / exposed
    9 / 9443 (0.10%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Transitional Cell Carcinoma Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Brain Neoplasm Benign
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast Cancer Stage I
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer Stage Ii
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Breast Cancer Stage Iii
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cancer Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid Tumour Of The Appendix
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carcinoid Tumour Pulmonary
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Myxoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Valve Fibroelastoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar Tumour
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Carcinoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervix Carcinoma Stage Ii
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholesteatoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Lymphocytic Leukaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Myeloid Leukaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Myelomonocytic Leukaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear Cell Renal Cell Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Adenoma
         subjects affected / exposed
    6 / 9443 (0.06%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer Metastatic
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Colon Cancer Stage Iii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon Cancer Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal Adenocarcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal Cancer Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Colorectal Cancer Stage Iii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniopharyngioma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ductal Adenocarcinoma Of Pancreas
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Endometrial Adenocarcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Cancer Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Stromal Tumour
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Tract Adenoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Glioblastoma Multiforme
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemangioma Of Bone
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hair Follicle Tumour Benign
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cancer
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hepatic Neoplasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hodgkin's Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hodgkin's Disease Stage Iv
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory Pseudotumour
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraductal Proliferative Breast Lesion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Lobular Breast Carcinoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Cell Lung Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Large Cell Lung Cancer Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Laryngeal Cancer Stage I
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Squamous Cell Carcinoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lentigo Maligna
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip Squamous Cell Carcinoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lipoma
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 3
    Lung Adenocarcinoma Stage I
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma Stage Ii
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Lung Cancer Metastatic
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung Carcinoma Cell Type Unspecified Stage I
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage Iii
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Carcinoma Cell Type Unspecified Stage Iv
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Lung Neoplasm
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    2 / 9443 (0.02%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung Squamous Cell Carcinoma Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung Squamous Cell Carcinoma Stage I
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Squamous Cell Carcinoma Stage Ii
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lung Squamous Cell Carcinoma Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lung Squamous Cell Carcinoma Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lymphoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Anorectal Neoplasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Ascites
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Glioma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant Melanoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma In Situ
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma Stage I
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Melanoma Stage Iv
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Palate Neoplasm
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant Pleural Effusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant Sweat Gland Neoplasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Bone
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastases To Central Nervous System
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Liver
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Metastases To Lung
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases To Lymph Nodes
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Peritoneum
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Spine
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Bronchial Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic Carcinoma Of The Bladder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metastatic Gastric Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Malignant Melanoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Neoplasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Renal Cell Carcinoma
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastatic Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Monoclonal Gammopathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mucinous Cystadenocarcinoma Ovary
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myeloproliferative Neoplasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nasal Cavity Cancer
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine Carcinoma Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Neuroendocrine Tumour
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuroendocrine Tumour Of The Lung
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine Tumour Of The Lung Metastatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Non-Hodgkin's Lymphoma
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-Hodgkin's Lymphoma Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Hodgkin's Lymphoma Recurrent
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-Small Cell Lung Cancer Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oesophageal Adenocarcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Adenocarcinoma Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal Cancer Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oropharyngeal Squamous Cell Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Adenoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma Metastatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatic Carcinoma Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pancreatic Carcinoma Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Pancreatic Neuroendocrine Tumour
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary Thyroid Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parathyroid Tumour Benign
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penile Cancer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Mesothelioma Malignant
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phaeochromocytoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary Tumour Benign
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Leukaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Plasma Cell Myeloma
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Plasmacytoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Mesothelioma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Polycythaemia Vera
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer
         subjects affected / exposed
    17 / 9443 (0.18%)
    18 / 9451 (0.19%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Metastatic
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Prostate Cancer Stage I
         subjects affected / exposed
    4 / 9443 (0.04%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Stage Ii
         subjects affected / exposed
    4 / 9443 (0.04%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Stage Iii
         subjects affected / exposed
    6 / 9443 (0.06%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate Cancer Stage Iv
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatic Adenoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Adenoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         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
    6 / 9443 (0.06%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Neoplasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectosigmoid Cancer Stage Ii
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cancer Metastatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Cancer Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma Stage Ii
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma Stage I
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma Stage Iii
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Oncocytoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Cancer Stage Iv
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Schwannoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seborrhoeic Keratosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinonasal Papilloma
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Cancer Metastatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skin Cancer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Papilloma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Cell Lung Cancer Limited Stage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 Metastatic
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Squamous Cell Carcinoma Of Lung
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous Cell Carcinoma Of Skin
         subjects affected / exposed
    6 / 9443 (0.06%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of The Cervix
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of The Hypopharynx
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous Cell Carcinoma Of The Tongue
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Squamous Cell Carcinoma Of The Vulva
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial Sarcoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Carcinoma Stage Iv
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsil Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional Cell Cancer Of Renal Pelvis And Ureter Metastatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transitional Cell Carcinoma
         subjects affected / exposed
    5 / 9443 (0.05%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour Haemorrhage
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Sarcoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Neoplasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Cancer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Cancer Metastatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Accelerated Hypertension
         subjects affected / exposed
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Aneurysm
         subjects affected / exposed
    12 / 9443 (0.13%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic Aneurysm Rupture
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Aortic Dissection
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Intramural Haematoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Stenosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aorto-Duodenal Fistula
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial Insufficiency
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Arteriovenous Fistula
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Pressure Inadequately Controlled
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory Collapse
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep Vein Thrombosis
         subjects affected / exposed
    8 / 9443 (0.08%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dry Gangrene
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Embolism Venous
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential Hypertension
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity Necrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hot Flush
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    36 / 9443 (0.38%)
    34 / 9451 (0.36%)
         occurrences causally related to treatment / all
    0 / 41
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Crisis
         subjects affected / exposed
    17 / 9443 (0.18%)
    21 / 9451 (0.22%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 22
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Emergency
         subjects affected / exposed
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    17 / 9443 (0.18%)
    16 / 9451 (0.17%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic Shock
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Iliac Artery Embolism
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac Artery Occlusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    6 / 9443 (0.06%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Limb Pain
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leriche Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphatic Fistula
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphoedema
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphorrhoea
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic Hypotension
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating Aortic Ulcer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    47 / 9443 (0.50%)
    27 / 9451 (0.29%)
         occurrences causally related to treatment / all
    1 / 49
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Aneurysm
         subjects affected / exposed
    2 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Dissection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Occlusion
         subjects affected / exposed
    13 / 9443 (0.14%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Stenosis
         subjects affected / exposed
    8 / 9443 (0.08%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral Ischaemia
         subjects affected / exposed
    20 / 9443 (0.21%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Peripheral Embolism
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Vascular Disorder
         subjects affected / exposed
    6 / 9443 (0.06%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Venous Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis Superficial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Raynaud's Phenomenon
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renovascular Hypertension
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Shock Haemorrhagic
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Subclavian Artery Occlusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior Vena Cava Occlusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Temporal Arteritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis Superficial
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous Thrombosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Discomfort
         subjects affected / exposed
    5 / 9443 (0.05%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    29 / 9443 (0.31%)
    25 / 9451 (0.26%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Death
         subjects affected / exposed
    33 / 9443 (0.35%)
    25 / 9451 (0.26%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 25
         deaths causally related to treatment / all
    0 / 33
    0 / 25
    Device Related Thrombosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise Tolerance Decreased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gait Disturbance
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General Physical Health Deterioration
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Granuloma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Haematoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Hernia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza Like Illness
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection Site Reaction
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Site Dermatitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Site Joint Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Site Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    222 / 9443 (2.35%)
    219 / 9451 (2.32%)
         occurrences causally related to treatment / all
    1 / 256
    1 / 264
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Organ Dysfunction Syndrome
         subjects affected / exposed
    8 / 9443 (0.08%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 5
         deaths causally related to treatment / all
    0 / 6
    0 / 4
    Oedema Peripheral
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pacemaker Generated Arrhythmia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Mass
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Swelling
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    6 / 9443 (0.06%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Soft Tissue Inflammation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    42 / 9443 (0.44%)
    36 / 9451 (0.38%)
         occurrences causally related to treatment / all
    0 / 42
    0 / 36
         deaths causally related to treatment / all
    0 / 42
    0 / 36
    Strangulated Hernia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Death
         subjects affected / exposed
    9 / 9443 (0.10%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 9
    0 / 14
    Systemic Inflammatory Response Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Stent Restenosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Stent Thrombosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel Puncture Site Haematoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vessel Puncture Site Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergy To Arthropod Sting
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Reaction
         subjects affected / exposed
    2 / 9443 (0.02%)
    4 / 9451 (0.04%)
         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
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast Media Allergy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iodine Allergy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Physical Assault
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 Hydrocele
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acquired Phimosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    13 / 9443 (0.14%)
    16 / 9451 (0.17%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Mass
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysfunctional Uterine Bleeding
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial Hyperplasia
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erectile Dysfunction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Menorrhagia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian Cyst
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peyronie's Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Ulcer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Cyst
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Haemorrhage
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Polyp
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Prolapse
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterovaginal Prolapse
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Dysplasia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vaginal Prolapse
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicocele
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulva Cyst
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    Acquired Diaphragmatic Eventration
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Pulmonary Oedema
         subjects affected / exposed
    10 / 9443 (0.11%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Respiratory Failure
         subjects affected / exposed
    24 / 9443 (0.25%)
    19 / 9451 (0.20%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 21
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    Adenoidal Hypertrophy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Asthma
         subjects affected / exposed
    6 / 9443 (0.06%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atelectasis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial Hyperreactivity
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiectasis
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Chronic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choking
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic Obstructive Pulmonary Disease
         subjects affected / exposed
    51 / 9443 (0.54%)
    38 / 9451 (0.40%)
         occurrences causally related to treatment / all
    0 / 76
    0 / 47
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Chronic Respiratory Failure
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    12 / 9443 (0.13%)
    20 / 9451 (0.21%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 21
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dyspnoea Exertional
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    12 / 9443 (0.13%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Haemothorax
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperventilation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoventilation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic Pulmonary Fibrosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial Lung Disease
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Laryngeal Oedema
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngospasm
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infiltration
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Mucosal Ulcer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Obstruction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Polyps
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Septum Deviation
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasal Turbinate Hypertrophy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
         subjects affected / exposed
    5 / 9443 (0.05%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic Pain
         subjects affected / exposed
    0 / 9443 (0.00%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Aspiration
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 2
    Pneumothorax
         subjects affected / exposed
    5 / 9443 (0.05%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Alveolar Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pulmonary Calcification
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Congestion
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    19 / 9443 (0.20%)
    16 / 9451 (0.17%)
         occurrences causally related to treatment / all
    2 / 19
    0 / 16
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Pulmonary Fibrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Infarction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Hypertension
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Mass
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Oedema
         subjects affected / exposed
    5 / 9443 (0.05%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Respiratory Acidosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Arrest
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Distress
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    15 / 9443 (0.16%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 5
    0 / 2
    Respiratory Tract Oedema
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis Allergic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Apnoea Syndrome
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillolith
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal Cord Polyp
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment Disorder With Mixed Disturbance Of Emotion And Conduct
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Psychosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Agoraphobia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Abuse
         subjects affected / exposed
    2 / 9443 (0.02%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic Psychosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholism
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anger
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bipolar I Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borderline Personality Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradyphrenia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Catatonia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    6 / 9443 (0.06%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 6
    0 / 3
    Confusional State
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Conversion Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium Tremens
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusional Disorder, Unspecified Type
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    25 / 9443 (0.26%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    2 / 26
    1 / 18
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Depression Suicidal
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Abuse
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Factitious Disorder
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Homicidal Ideation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Insomnia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major Depression
         subjects affected / exposed
    2 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental Status Changes
         subjects affected / exposed
    4 / 9443 (0.04%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mood Disorder Due To A General Medical Condition
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic Attack
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Stress Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Behaviour
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal Ideation
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    2 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide Attempt
         subjects affected / exposed
    14 / 9443 (0.15%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    1 / 15
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Psychosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    11 / 9443 (0.12%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 11
    1 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation Drug Level Above Therapeutic
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Calcium Increased
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Phosphokinase Mb Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    2 / 4
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Potassium Increased
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood Pressure Increased
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Natriuretic Peptide Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Stress Test Abnormal
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.01%)
    2 / 9451 (0.02%)
         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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exercise Electrocardiogram Abnormal
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiv Test Positive
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocrit Decreased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematocrit Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Enzyme Abnormal
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Enzyme Increased
         subjects affected / exposed
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C Virus Test Positive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human Papilloma Virus Test Positive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza A Virus Test Positive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International Normalised Ratio Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Function Test Abnormal
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Function Test Increased
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycobacterium Tuberculosis Complex Test Positive
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scan Myocardial Perfusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    2 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour Marker Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    White Blood Cell Count Increased
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Abdominal Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Wound Dehiscence
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental Overdose
         subjects affected / exposed
    9 / 9443 (0.10%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    5 / 14
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acetabulum Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic Transfusion Reaction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Postoperative
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaesthetic Complication Neurological
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Arterial Bypass Thrombosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod Bite
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthropod Sting
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Auricular Haematoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blast Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Contusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachial Plexus Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Contusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Brain Herniation
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carbon Monoxide Poisoning
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac Contusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Valve Replacement Complication
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cervical Vertebral Fracture
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chemical Burn Of Gastrointestinal Tract
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    5 / 9443 (0.05%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    8 / 9443 (0.08%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Confusion Postoperative
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Restenosis
         subjects affected / exposed
    8 / 9443 (0.08%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral Injury
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Delayed Recovery From Anaesthesia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Extra-Axial Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Face Injury
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    32 / 9443 (0.34%)
    26 / 9451 (0.28%)
         occurrences causally related to treatment / all
    0 / 34
    0 / 26
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Femoral Neck Fracture
         subjects affected / exposed
    6 / 9443 (0.06%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur Fracture
         subjects affected / exposed
    9 / 9443 (0.10%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body In Urogenital Tract
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture Displacement
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fractured Skull Depressed
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal Stoma Necrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gun Shot Wound
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hand Fracture
         subjects affected / exposed
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Heat Stroke
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    2 / 9443 (0.02%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyphaema
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision Site Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional Overdose
         subjects affected / exposed
    8 / 9443 (0.08%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Jaw Fracture
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Dislocation
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Rupture
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament Sprain
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Crushing Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Injury
         subjects affected / exposed
    6 / 9443 (0.06%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb Traumatic Amputation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip Injury
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Vertebral Fracture
         subjects affected / exposed
    5 / 9443 (0.05%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallet Finger
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscus Injury
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Fractures
         subjects affected / exposed
    0 / 9443 (0.00%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Muscle Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Rupture
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Strain
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Root Injury Lumbar
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Fracture
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Penetrating Abdominal Trauma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Restenosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprosthetic Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirenal Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax Traumatic
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Concussion Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Laminectomy Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Bile Leak
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Fistula
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haematuria
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Haemorrhage
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Inflammation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Pulmonary Embolism
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Swelling
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post-Traumatic Pain
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Ileus
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Renal Failure
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Respiratory Failure
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thoracic Procedure Complication
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Procedural Hypertension
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Hypotension
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Intestinal Perforation
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pain
         subjects affected / exposed
    5 / 9443 (0.05%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural Pneumothorax
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pubis Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Contusion
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation Associated Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiation Skin Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    7 / 9443 (0.07%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    19 / 9443 (0.20%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Scapula Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Haematoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Silicosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Soft Tissue Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Compression Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic Rupture
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab Wound
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma Site Discharge
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomal Hernia
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid Haemorrhage
         subjects affected / exposed
    8 / 9443 (0.08%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Tendon Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon Rupture
         subjects affected / exposed
    7 / 9443 (0.07%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic Vertebral Fracture
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    5 / 9443 (0.05%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Tracheostomy Malfunction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haematoma
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haemothorax
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Intracranial Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Liver Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Renal Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulna Fracture
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention Postoperative
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Access Site Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Access Site Pseudoaneurysm
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Graft Occlusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Pseudoaneurysm Ruptured
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Dehiscence
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist Fracture
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Atrial Septal Defect
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicuspid Aortic Valve
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchogenic Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermoid Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Arteriovenous Malformation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hereditary Optic Atrophy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinocerebellar Ataxia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroglossal Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Von Hippel-Lindau Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Coronary Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute Left Ventricular Failure
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Myocardial Infarction
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adams-Stokes Syndrome
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Pectoris
         subjects affected / exposed
    133 / 9443 (1.41%)
    113 / 9451 (1.20%)
         occurrences causally related to treatment / all
    0 / 148
    0 / 136
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    8 / 9443 (0.08%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    1 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Disease Mixed
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Incompetence
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic Valve Sclerosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    17 / 9443 (0.18%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 9443 (0.01%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Arrhythmia Supraventricular
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis Coronary Artery
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriospasm Coronary
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    98 / 9443 (1.04%)
    82 / 9451 (0.87%)
         occurrences causally related to treatment / all
    0 / 110
    0 / 103
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial Flutter
         subjects affected / exposed
    10 / 9443 (0.11%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 14
    1 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Tachycardia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Complete
         subjects affected / exposed
    6 / 9443 (0.06%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block First Degree
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular Block Second Degree
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    9 / 9443 (0.10%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Left
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bundle Branch Block Right
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Aneurysm
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    9 / 9443 (0.10%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Discomfort
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Failure
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Cardiac Failure Acute
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiac Failure Chronic
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    5 / 9443 (0.05%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Flutter
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Perforation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Tamponade
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Cardiogenic Shock
         subjects affected / exposed
    6 / 9443 (0.06%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Cardiomyopathy
         subjects affected / exposed
    6 / 9443 (0.06%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chordae Tendinae Rupture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congestive Cardiomyopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    20 / 9443 (0.21%)
    25 / 9451 (0.26%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary Artery Dissection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Occlusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Stenosis
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diastolic Dysfunction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrasystoles
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracardiac Mass
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Cardiomyopathy
         subjects affected / exposed
    9 / 9443 (0.10%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Mitral Regurgitation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left Ventricular Dysfunction
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Low Cardiac Output Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microvascular Coronary Artery Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Incompetence
         subjects affected / exposed
    7 / 9443 (0.07%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral Valve Prolapse
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Myocardial Ischaemia
         subjects affected / exposed
    13 / 9443 (0.14%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Myocardial Rupture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocarditis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nodal Arrhythmia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palpitations
         subjects affected / exposed
    5 / 9443 (0.05%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary Muscle Rupture
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Effusion
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuropericarditis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prinzmetal Angina
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless Electrical Activity
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhythm Idioventricular
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sinus Arrest
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Arrhythmia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Bradycardia
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Node Dysfunction
         subjects affected / exposed
    9 / 9443 (0.10%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus Tachycardia
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Cardiomyopathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Extrasystoles
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    12 / 9443 (0.13%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systolic Dysfunction
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachyarrhythmia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tricuspid Valve Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ventricular Arrhythmia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Extrasystoles
         subjects affected / exposed
    5 / 9443 (0.05%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Fibrillation
         subjects affected / exposed
    17 / 9443 (0.18%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 8
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Ventricular Hypokinesia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular Tachycardia
         subjects affected / exposed
    29 / 9443 (0.31%)
    24 / 9451 (0.25%)
         occurrences causally related to treatment / all
    0 / 33
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Nervous system disorders
    Alcoholic Seizure
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amnesia
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    1 / 3
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amyotrophic Lateral Sclerosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphasia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autonomic Nervous System Imbalance
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Axonal Neuropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Balance Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Injury
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Brain Oedema
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Carotid Arteriosclerosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Occlusion
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Stenosis
         subjects affected / exposed
    19 / 9443 (0.20%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Artery Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid Sinus Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    6 / 9443 (0.06%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cauda Equina Syndrome
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Atrophy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Ischaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrospinal Fistula
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cervical Radiculopathy
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Inflammatory Demyelinating Polyradiculoneuropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cognitive Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coma
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Coordination Abnormal
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cubital Tunnel Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia
         subjects affected / exposed
    0 / 9443 (0.00%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dementia Alzheimer's Type
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelinating Polyneuropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depressed Level Of Consciousness
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Encephalopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Neuropathy
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness Exertional
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    6 / 9443 (0.06%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epileptic Encephalopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Essential Tremor
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extrapyramidal Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Paralysis
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal Dyscognitive Seizures
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised Tonic-Clonic Seizure
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage Intracranial
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Stroke
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Headache
         subjects affected / exposed
    7 / 9443 (0.07%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemianopia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiplegia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperaesthesia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Seizure
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic Seizure
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemic Seizure
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-Ischaemic Encephalopathy
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intercostal Neuralgia
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Aneurysm
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Mass
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial Venous Sinus Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limbic Encephalitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    8 / 9443 (0.08%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Radiculopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbosacral Radiculopathy
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Memory Impairment
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Encephalopathy
         subjects affected / exposed
    2 / 9443 (0.02%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine With Aura
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mixed Dementia
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         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 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple Sclerosis Relapse
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myoclonus
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nerve Compression
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuralgia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuromuscular Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    4 / 9443 (0.04%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occipital Neuralgia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paraesthesia
         subjects affected / exposed
    8 / 9443 (0.08%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paralysis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson's Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinsonism
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures With Secondary Generalisation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Nerve Lesion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit Mal Epilepsy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior Reversible Encephalopathy Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postictal Paralysis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    2 / 9443 (0.02%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyramidal Tract Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radial Nerve Palsy
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radicular Pain
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radiculopathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ruptured Cerebral Aneurysm
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 9443 (0.01%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    7 / 9443 (0.07%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sensory Loss
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Cord Compression
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylitic Myelopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    73 / 9443 (0.77%)
    67 / 9451 (0.71%)
         occurrences causally related to treatment / all
    0 / 82
    1 / 73
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Toxic Encephalopathy
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Global Amnesia
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient Ischaemic Attack
         subjects affected / exposed
    2 / 9443 (0.02%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Trigeminal Neuralgia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar Neuritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulnar Tunnel Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paralysis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vith Nerve Paresis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar Insufficiency
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Cns Origin
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    15 / 9443 (0.16%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Chronic Disease
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Of Malignant Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia Vitamin B12 Deficiency
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune Haemolytic Anaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disseminated Intravascular Coagulation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Neutropenia
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic Anaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Anaemia
         subjects affected / exposed
    17 / 9443 (0.18%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 15
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Haemorrhagic Diathesis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic Anaemia
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron Deficiency Anaemia
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic Anaemia
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrogenic Anaemia
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normochromic Normocytic Anaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Normocytic Anaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    6 / 9443 (0.06%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombotic Thrombocytopenic Purpura
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Acute Vestibular Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoacusis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sudden Hearing Loss
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic Membrane Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tympanic Membrane Perforation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    12 / 9443 (0.13%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Labyrinthine
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo Positional
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Amaurosis Fugax
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blepharochalasis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    13 / 9443 (0.14%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    1 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Diabetic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract Subcapsular
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctival Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Corneal Degeneration
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Retinopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Muscle Entrapment
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Macular Degeneration
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular Myasthenia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Optic Ischaemic Neuropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior Capsule Opacification
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Artery Embolism
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Artery Occlusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Detachment
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal Vein Occlusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcerative Keratitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual Acuity Reduced
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous Detachment
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Adhesions
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Discomfort
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Distension
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Hernia
         subjects affected / exposed
    5 / 9443 (0.05%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Incarcerated Hernia
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain
         subjects affected / exposed
    12 / 9443 (0.13%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Pain Upper
         subjects affected / exposed
    6 / 9443 (0.06%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal Strangulated Hernia
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal Wall Haematoma
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic Pancreatitis
         subjects affected / exposed
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Anal Fissure
         subjects affected / exposed
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Incontinence
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Polyp
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aphthous Ulcer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendix Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Barrett's Oesophagus
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Acid Malabsorption
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breath Odour
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Gastritis
         subjects affected / exposed
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    7 / 9443 (0.07%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    6 / 9443 (0.06%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Colitis Microscopic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ulcerative
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental Caries
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gastroparesis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    7 / 9443 (0.07%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dieulafoy's Vascular Malformation
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum Intestinal Haemorrhagic
         subjects affected / exposed
    4 / 9443 (0.04%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Obstruction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    5 / 9443 (0.05%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Ulcer Haemorrhage
         subjects affected / exposed
    9 / 9443 (0.10%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal Vascular Ectasia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenitis Haemorrhagic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    6 / 9443 (0.06%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Haemorrhagic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Duodenitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erosive Oesophagitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faecaloma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral Hernia, Obstructive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula Of Small Intestine
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Food Poisoning
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional Gastrointestinal Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    11 / 9443 (0.12%)
    14 / 9451 (0.15%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 14
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Ulcer, Obstructive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    17 / 9443 (0.18%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 19
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Erosive
         subjects affected / exposed
    3 / 9443 (0.03%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Haemorrhagic
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroduodenitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Angiectasia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Angiodysplasia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Angiodysplasia Haemorrhagic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    13 / 9443 (0.14%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 12
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Gastrointestinal Inflammation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Mucosal Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Pain
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Polyp Haemorrhage
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Ulcer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    19 / 9443 (0.20%)
    21 / 9451 (0.22%)
         occurrences causally related to treatment / all
    0 / 20
    0 / 24
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gingival Bleeding
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    2 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic Erosive Gastritis
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal Haemorrhage
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hiatus Hernia Strangulated
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileal Perforation
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Hiatus Hernia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Umbilical Hernia
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    15 / 9443 (0.16%)
    29 / 9451 (0.31%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 29
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Infarction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Intestinal Ischaemia
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Intestinal Obstruction
         subjects affected / exposed
    6 / 9443 (0.06%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Obstruction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestinal Ulcer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Perforation
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         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
    2 / 9443 (0.02%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Gastrointestinal Haemorrhage
         subjects affected / exposed
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Hernia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mallory-Weiss Syndrome
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Megacolon
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric Artery Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Mesenteric Panniculitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstruction Gastric
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Pancreatitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Odynophagia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedematous Pancreatitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Achalasia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Rupture
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Spasm
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Stenosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Ulcer Haemorrhage
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Varices Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophagitis Haemorrhagic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Failure
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    0 / 9451 (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
    6 / 9443 (0.06%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    16 / 9443 (0.17%)
    15 / 9451 (0.16%)
         occurrences causally related to treatment / all
    0 / 16
    3 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Chronic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Necrotising
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic Ulcer
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         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
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontal Disease
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Prolapse
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal Haemorrhage
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Duct Obstruction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Calculus
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    4 / 9443 (0.04%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Perforation
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Ulcer Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swollen Tongue
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tongue Haematoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toothache
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia
         subjects affected / exposed
    7 / 9443 (0.07%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Umbilical Hernia, Obstructive
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Gastrointestinal Haemorrhage
         subjects affected / exposed
    7 / 9443 (0.07%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 8
    1 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Varices Oesophageal
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    6 / 9443 (0.06%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute Hepatic Failure
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ampulla Of Vater Stenosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile Duct Stenosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         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
    7 / 9443 (0.07%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    1 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Colic
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Dyskinesia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Tract Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Acute
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Sclerosing
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    14 / 9443 (0.15%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Acute
         subjects affected / exposed
    14 / 9443 (0.15%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cholecystitis Chronic
         subjects affected / exposed
    6 / 9443 (0.06%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    35 / 9443 (0.37%)
    25 / 9451 (0.26%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 25
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholestasis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Hepatitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cirrhosis Alcoholic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Drug-Induced Liver Injury
         subjects affected / exposed
    6 / 9443 (0.06%)
    15 / 9451 (0.16%)
         occurrences causally related to treatment / all
    0 / 6
    5 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Necrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Perforation
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Congestion
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Failure
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatic Function Abnormal
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Lesion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Necrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Steatosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Vein Dilatation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Acute
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Alcoholic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Chronic Active
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis Toxic
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperplastic Cholecystopathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice Cholestatic
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Liver Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Injury
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Steatohepatitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    7 / 9443 (0.07%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    2 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus Ulcer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermal Cyst
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Allergic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Atopic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Bullous
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Contact
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Exfoliative Generalised
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatomyositis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot
         subjects affected / exposed
    11 / 9443 (0.12%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diabetic Neuropathic Ulcer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ulcer
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Eruption
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Reaction With Eosinophilia And Systemic Symptoms
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema Nummular
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema Multiforme
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythrodermic Psoriasis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intertrigo
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Photosensitivity Reaction
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus Allergic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Erythematous
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash Pruritic
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scar Pain
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Lesion
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Ulcer
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Swelling Face
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria Chronic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular Purpura
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 Kidney Injury
         subjects affected / exposed
    62 / 9443 (0.66%)
    57 / 9451 (0.60%)
         occurrences causally related to treatment / all
    0 / 74
    1 / 59
         deaths causally related to treatment / all
    0 / 5
    0 / 6
    Acute Prerenal Failure
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Dilatation
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Outlet Obstruction
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Perforation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Tamponade
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic Kidney Disease
         subjects affected / exposed
    15 / 9443 (0.16%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    1 / 16
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Glandularis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Interstitial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis Noninfective
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Cystopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Nephropathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End Stage Renal Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Glomerulonephritis Proliferative
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    13 / 9443 (0.14%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    6 / 9443 (0.06%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive Nephropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iga Nephropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Urinary Tract Symptoms
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    21 / 9443 (0.22%)
    15 / 9451 (0.16%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephropathy Toxic
         subjects affected / exposed
    6 / 9443 (0.06%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrosclerosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvi-Ureteric Obstruction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postrenal Failure
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Artery Occlusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Colic
         subjects affected / exposed
    6 / 9443 (0.06%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cyst Haemorrhage
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    6 / 9443 (0.06%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal Haematoma
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Impairment
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Infarct
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Mass
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Pain
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Tubular Disorder
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Renal Tubular Necrosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Vein Thrombosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress Urinary Incontinence
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tubulointerstitial Nephritis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteral Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric Stenosis
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Stenosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    15 / 9443 (0.16%)
    12 / 9451 (0.13%)
         occurrences causally related to treatment / all
    0 / 15
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Haemorrhage
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Bladder Rupture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Incontinence
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Retention
         subjects affected / exposed
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Obstruction
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinoma
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urogenital Fistula
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenocortical Insufficiency Acute
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adrenocorticotropic Hormone Deficiency
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Autoimmune Hypothyroidism
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Basedow's Disease
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Goitre
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothyroidism
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate Antidiuretic Hormone Secretion
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pituitary Cyst
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Mass
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Goitre
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Nodular Goitre
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Ankylosing Spondylitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    7 / 9443 (0.07%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthrofibrosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back Pain
         subjects affected / exposed
    10 / 9443 (0.11%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone Cyst
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical Spinal Stenosis
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondropathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Compartment Syndrome
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    6 / 9443 (0.06%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dupuytren's Contracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enthesopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoroacetabular Impingement
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Deformity
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty Arthritis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Degeneration
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Disorder
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Disc Protrusion
         subjects affected / exposed
    21 / 9443 (0.22%)
    21 / 9451 (0.22%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Effusion
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Instability
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint Range Of Motion Decreased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    9 / 9443 (0.10%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meniscal Degeneration
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility Decreased
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Necrosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Spasms
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle Tightness
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular Weakness
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Chest Pain
         subjects affected / exposed
    35 / 9443 (0.37%)
    24 / 9451 (0.25%)
         occurrences causally related to treatment / all
    1 / 44
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal Pain
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    5 / 9443 (0.05%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myopathy
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myositis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neck Pain
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neuropathic Arthropathy
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    46 / 9443 (0.49%)
    50 / 9451 (0.53%)
         occurrences causally related to treatment / all
    0 / 51
    0 / 54
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    4 / 9443 (0.04%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteopenia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    6 / 9443 (0.06%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological Fracture
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periarthritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia Rheumatica
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoriatic Arthropathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    7 / 9443 (0.07%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    4 / 7
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatic Fever
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid Arthritis
         subjects affected / exposed
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator Cuff Syndrome
         subjects affected / exposed
    8 / 9443 (0.08%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Column Stenosis
         subjects affected / exposed
    5 / 9443 (0.05%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Disorder
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Ligament Ossification
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Osteoarthritis
         subjects affected / exposed
    8 / 9443 (0.08%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal Pain
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spondylolisthesis
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sympathetic Posterior Cervical Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovial Cyst
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Lupus Erythematosus
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendonitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebral Foraminal Stenosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abdominal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Abdominal Sepsis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    4 / 9443 (0.04%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Endocarditis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Hepatitis C
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendiceal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    10 / 9443 (0.11%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis Bacterial
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atypical Pneumonia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Prostatitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bone Tuberculosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Borrelia Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cellulitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    17 / 9443 (0.18%)
    16 / 9451 (0.17%)
         occurrences causally related to treatment / all
    1 / 21
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Bacterial
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis Viral
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brucellosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis Infective
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Campylobacter Gastroenteritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cellulitis
         subjects affected / exposed
    37 / 9443 (0.39%)
    32 / 9451 (0.34%)
         occurrences causally related to treatment / all
    1 / 40
    0 / 35
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Of Male External Genital Organ
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis Staphylococcal
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis Infective
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis Infective
         subjects affected / exposed
    2 / 9443 (0.02%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Chronic Sinusitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Citrobacter Sepsis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    3 / 9443 (0.03%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cutaneous Tuberculosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cystitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    8 / 9443 (0.08%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-Hypodermitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Foot Infection
         subjects affected / exposed
    5 / 9443 (0.05%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Gangrene
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    10 / 9443 (0.11%)
    9 / 9451 (0.10%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis Intestinal Haemorrhagic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocarditis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Enterobacter Bacteraemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal Bacteraemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterococcal Sepsis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Bacterial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterocolitis Infectious
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    8 / 9443 (0.08%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    1 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Pyelonephritis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Sepsis
         subjects affected / exposed
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia Urinary Tract Infection
         subjects affected / exposed
    3 / 9443 (0.03%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    External Ear Cellulitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extradural Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder Empyema
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    6 / 9443 (0.06%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastric Ulcer Helicobacter
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis Viral
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    25 / 9443 (0.26%)
    26 / 9451 (0.28%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 31
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Bacterial
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Salmonella
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin Abscess
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus Sepsis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hantaviral Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter Gastritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Amoebiasis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Infection Bacterial
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Virus Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Zoster
         subjects affected / exposed
    0 / 9443 (0.00%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iatrogenic Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Implant Site Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Bite
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Cyst
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected Skin Ulcer
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Colitis
         subjects affected / exposed
    4 / 9443 (0.04%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Pleural Effusion
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective Exacerbation Of Chronic Obstructive Airways Disease
         subjects affected / exposed
    7 / 9443 (0.07%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Influenza
         subjects affected / exposed
    5 / 9443 (0.05%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injection Site Cellulitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella Bacteraemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Latent Tuberculosis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    5 / 9443 (0.05%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    10 / 9443 (0.11%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ludwig Angina
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Infection
         subjects affected / exposed
    2 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lyme Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mediastinitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical Device Site Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Aseptic
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningoencephalitis Bacterial
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Necrotising Fasciitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ophthalmic Herpes Zoster
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral Herpes
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    8 / 9443 (0.08%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Acute
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Externa
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media Acute
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreas Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pelvic Inflammatory Disease
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perichondritis
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perihepatic Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periodontitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital Cellulitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.02%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngolaryngeal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal Cyst
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy Viral
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    108 / 9443 (1.14%)
    96 / 9451 (1.02%)
         occurrences causally related to treatment / all
    1 / 123
    0 / 98
         deaths causally related to treatment / all
    0 / 7
    0 / 4
    Pneumonia Bacterial
         subjects affected / exposed
    3 / 9443 (0.03%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 3
    1 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Chlamydial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Escherichia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Haemophilus
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Influenzal
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Klebsiella
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Legionella
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Mycoplasmal
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Pneumococcal
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia Staphylococcal
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia Streptococcal
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    3 / 9443 (0.03%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Cellulitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Infection
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Pneumonia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Procedural Sepsis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post Viral Fatigue Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative Wound Infection
         subjects affected / exposed
    13 / 9443 (0.14%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Proctitis Bacterial
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomembranous Colitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal Bacteraemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psoas Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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 / 9443 (0.01%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    4 / 9443 (0.04%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pyelonephritis
         subjects affected / exposed
    9 / 9443 (0.10%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    5 / 9443 (0.05%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Chronic
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    4 / 9443 (0.04%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal Abscess
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrub Typhus
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    35 / 9443 (0.37%)
    20 / 9451 (0.21%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 20
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Septic Shock
         subjects affected / exposed
    12 / 9443 (0.13%)
    11 / 9451 (0.12%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 11
         deaths causally related to treatment / all
    0 / 5
    0 / 3
    Sinusitis
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis Bacterial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         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
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Osteomyelitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Sepsis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Bacteraemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Endocarditis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous Abscess
         subjects affected / exposed
    5 / 9443 (0.05%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic Infection
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    5 / 9443 (0.05%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxic Shock Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tuberculosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    9 / 9443 (0.10%)
    7 / 9451 (0.07%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tuberculous Pleurisy
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    33 / 9443 (0.35%)
    27 / 9451 (0.29%)
         occurrences causally related to treatment / all
    0 / 35
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection Bacterial
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 Enterococcal
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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 Staphylococcal
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (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
    10 / 9443 (0.11%)
    16 / 9451 (0.17%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 16
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Viral Cardiomyopathy
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular Neuronitis
         subjects affected / exposed
    3 / 9443 (0.03%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    6 / 9443 (0.06%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Labyrinthitis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Myocarditis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Pericarditis
         subjects affected / exposed
    1 / 9443 (0.01%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 9443 (0.02%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visceral Leishmaniasis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulval Abscess
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vulvovaginal Candidiasis
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         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
    4 / 9443 (0.04%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound Infection Staphylococcal
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    13 / 9443 (0.14%)
    13 / 9451 (0.14%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus
         subjects affected / exposed
    3 / 9443 (0.03%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes Mellitus Inadequate Control
         subjects affected / exposed
    16 / 9443 (0.17%)
    20 / 9451 (0.21%)
         occurrences causally related to treatment / all
    0 / 21
    1 / 20
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Complication
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketoacidosis
         subjects affected / exposed
    9 / 9443 (0.10%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Ketosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Metabolic Decompensation
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte Imbalance
         subjects affected / exposed
    0 / 9443 (0.00%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Overload
         subjects affected / exposed
    3 / 9443 (0.03%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid Retention
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 9443 (0.02%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperammonaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    2 / 9443 (0.02%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    9 / 9443 (0.10%)
    10 / 9451 (0.11%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemic Hyperosmolar Nonketotic Syndrome
         subjects affected / exposed
    4 / 9443 (0.04%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperinsulinaemic Hypoglycaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    7 / 9443 (0.07%)
    4 / 9451 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hypernatraemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperuricaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoalbuminaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    7 / 9443 (0.07%)
    6 / 9451 (0.06%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    10 / 9443 (0.11%)
    8 / 9451 (0.08%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 13
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypomagnesaemia
         subjects affected / exposed
    1 / 9443 (0.01%)
    2 / 9451 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    8 / 9443 (0.08%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    2 / 9443 (0.02%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic Acidosis
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    4 / 9443 (0.04%)
    5 / 9451 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Metabolic Disorder
         subjects affected / exposed
    1 / 9443 (0.01%)
    0 / 9451 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Syndrome
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    6 / 9443 (0.06%)
    3 / 9451 (0.03%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    0 / 9443 (0.00%)
    1 / 9451 (0.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 Diabetes Mellitus
         subjects affected / exposed
    36 / 9443 (0.38%)
    37 / 9451 (0.39%)
         occurrences causally related to treatment / all
    0 / 36
    1 / 37
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Alirocumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2181 / 9443 (23.10%)
    2203 / 9451 (23.31%)
    Investigations
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    488 / 9443 (5.17%)
    457 / 9451 (4.84%)
         occurrences all number
    560
    521
    Vascular disorders
    Hypertension
         subjects affected / exposed
    574 / 9443 (6.08%)
    542 / 9451 (5.73%)
         occurrences all number
    678
    600
    General disorders and administration site conditions
    Non-Cardiac Chest Pain
         subjects affected / exposed
    462 / 9443 (4.89%)
    481 / 9451 (5.09%)
         occurrences all number
    556
    591
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    496 / 9443 (5.25%)
    522 / 9451 (5.52%)
         occurrences all number
    563
    591
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    532 / 9443 (5.63%)
    567 / 9451 (6.00%)
         occurrences all number
    697
    713

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Sep 2012
    - Change in the wording of the exclusion criteria E07 and E23 for clarification purpose. - The waived CV efficacy endpoints (primary and secondary efficacy endpoints) were to be reported only in the specific outcome event screens of the electronic Case Report Form (e-CRF) and no longer required to also be reported in the AE screen, to avoid duplication of data.
    05 Dec 2013
    - Update/clarifications in the definition of the efficacy endpoints. - Adjustment of some inclusion/exclusion criteria. - Run-in period: clarifications and simplifications provided. - Lipid monitoring and LMT post-randomization: adjustment/clarifications. - Clarification in safety (Serious Adverse Event) section and addition of analysis of CV events of interest related to peripheral artery disease (PAD) and venous thromboembolic events.
    16 Apr 2015
    Based on the need to randomize at least 600 subjects in China for local regulatory purposes and since the Clinical Trial Application approval in China was delayed resulting in a late start of randomization, the closing of randomization was to be performed in 2 sequential steps. - First step was to close randomization in all countries except China shortly after a total of 18,000 subjects had been randomized globally. - Second step was to close randomization in China shortly after a total of 600 subjects had been randomized to China or at common study end date (CSED), whichever came first. Neurologic and neurocognitive events were considered as adverse event of special interests (AESIs), and those events leading to additional examinations/procedures and/or referral to a specialist were considered as AESI with immediate notification and subject to expedited reporting (within 24 hours) to the Sponsor.
    25 Feb 2016
    To streamline the requirements for the end of the study: only one final visit, called the CSED visit, was to be performed for all randomized subjects, at the end of the study and within 30 days of the CSED. The additional follow-up contact that was initially planned to be performed 8 weeks after that visit for subjects still on study treatment at the time of the CSED was no longer required.

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

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

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