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    Clinical Trial Results:
    A multi-center, randomized, double-blind, active-controlled, parallel-group Phase 3 study to evaluate the efficacy and safety of LCZ696 compared to ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction (AMI)

    Summary
    EudraCT number
    		 2016-002154-20
    Trial protocol
    		 DE   PT   CZ   GB   GR   AT   SK   NL   ES   HU   BE   DK   SE   FI   BG   HR   IT  
    Global end of trial date
    26 Feb 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2022
    First version publication date
    16 Feb 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CLCZ696G2301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02924727
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharmaceuticals, +41 613241111, Novartis.email@novartis.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
    26 Feb 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that sacubitril/valsartan was superior to ramipril in delaying the time-to-first occurrence of the composite endpoint of CV death, HF hospitalization or outpatient HF in patients with LV systolic dysfunction and/or pulmonary congestion following an acute myocardial infarction (AMI)
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 251
    Country: Number of subjects enrolled
    Australia: 59
    Country: Number of subjects enrolled
    Austria: 110
    Country: Number of subjects enrolled
    Belgium: 80
    Country: Number of subjects enrolled
    Brazil: 178
    Country: Number of subjects enrolled
    Bulgaria: 211
    Country: Number of subjects enrolled
    Canada: 73
    Country: Number of subjects enrolled
    China: 211
    Country: Number of subjects enrolled
    Colombia: 134
    Country: Number of subjects enrolled
    Croatia: 53
    Country: Number of subjects enrolled
    Czechia: 152
    Country: Number of subjects enrolled
    Denmark: 131
    Country: Number of subjects enrolled
    Finland: 25
    Country: Number of subjects enrolled
    France: 144
    Country: Number of subjects enrolled
    Germany: 271
    Country: Number of subjects enrolled
    Greece: 66
    Country: Number of subjects enrolled
    Hungary: 228
    Country: Number of subjects enrolled
    India: 330
    Country: Number of subjects enrolled
    Israel: 101
    Country: Number of subjects enrolled
    Italy: 160
    Country: Number of subjects enrolled
    Korea, Republic of: 48
    Country: Number of subjects enrolled
    Mexico: 88
    Country: Number of subjects enrolled
    Netherlands: 341
    Country: Number of subjects enrolled
    Norway: 35
    Country: Number of subjects enrolled
    Peru: 28
    Country: Number of subjects enrolled
    Philippines: 51
    Country: Number of subjects enrolled
    Poland: 45
    Country: Number of subjects enrolled
    Portugal: 67
    Country: Number of subjects enrolled
    Romania: 192
    Country: Number of subjects enrolled
    Russian Federation: 323
    Country: Number of subjects enrolled
    Singapore: 87
    Country: Number of subjects enrolled
    Slovakia: 153
    Country: Number of subjects enrolled
    South Africa: 45
    Country: Number of subjects enrolled
    Spain: 167
    Country: Number of subjects enrolled
    Sweden: 76
    Country: Number of subjects enrolled
    Switzerland: 43
    Country: Number of subjects enrolled
    Taiwan: 90
    Country: Number of subjects enrolled
    Thailand: 80
    Country: Number of subjects enrolled
    Turkey: 76
    Country: Number of subjects enrolled
    United Kingdom: 203
    Country: Number of subjects enrolled
    United States: 455
    Worldwide total number of subjects
    5661
    EEA total number of subjects
    2707
    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)
    2837
    From 65 to 84 years
    2708
    85 years and over
    116

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 5669 patients were randomized in a 1:1 ratio to the sacubitril/valsartan treatment group and the ramipril treatment group at 493 sites in 41 countries. A total of 8 patients were mis-randomized, 4 from each treatment group. The Full analysis set (FAS) was comprised of 5661 patients.

    Pre-assignment
    Screening details
    		 A total of 5669 patients were randomized in a 1:1 ratio to the sacubitril/valsartan treatment group and the ramipril treatment group at 493 sites in 41 countries. A total of 8 patients were mis-randomized, 4 from each treatment group. The Full analysis set (FAS) was comprised of 5661 patients.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LCZ696 (sacubitril/valsartan)
    Arm description
    		 Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LCZ696 (sacubitril/valsartan)
    Investigational medicinal product code
    LCZ696
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match LCZ696 50 mg, 100 mg, 200 mg

    Investigational medicinal product name
    LCZ696 (sacubitril/valsartan)
    Investigational medicinal product code
    LCZ696
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg

    Investigational medicinal product name
    LCZ696 (sacubitril/valsartan)
    Investigational medicinal product code
    LCZ696
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg

    Arm title
    		 Ramipril
    Arm description
    		 Following randomization, patients received Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients were required to take a total of two pills, (one capsule from the Ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to Ramipril who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization immediately started on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients received two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ramipril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    1.2 mg

    Investigational medicinal product name
    Ramipril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    2.5 mg

    Investigational medicinal product name
    Ramipril
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5 mg

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet, Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo to match Ramipril 1.25 mg, 2.5 mg, 5 mg

    Number of subjects in period 1
    		LCZ696 (sacubitril/valsartan) Ramipril
    Started
    2830
    2831
    Completed
    2605
    2576
    Not completed
    225
    255
         Adverse event, serious fatal
    221
    246
         Consent withdrawn by subject
    2
    4
         Lost to follow-up
    2
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LCZ696 (sacubitril/valsartan)
    Reporting group description
    		 Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

    Reporting group title
    Ramipril
    Reporting group description
    		 Following randomization, patients received Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients were required to take a total of two pills, (one capsule from the Ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to Ramipril who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization immediately started on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients received two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.

    Reporting group values
    		 LCZ696 (sacubitril/valsartan) Ramipril Total
    Number of subjects
    		 2830 2831 5661
    Age Categorical
    Age Customized
    Units: Participants
        18 years to <65 years
    		 1386 1451 2837
        ≥65 years to ≥85
    		 1377 1331 2708
        >85 years
    		 67 49 116
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 64.0 ( 11.63 ) 63.5 ( 11.36 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 663 700 1363
        Male
    		 2167 2131 4298
    Race/Ethnicity, Customized
    Race/Ethnicity
    Units: Subjects
        Caucasian
    		 2125 2138 4263
        Black
    		 35 40 75
        Asian
    		 475 478 953
        Native American
    		 45 45 90
        Pacific Islander
    		 0 4 4
        Unknown
    		 22 21 43
        Other
    		 128 105 233

    End points

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    End points reporting groups
    Reporting group title
    LCZ696 (sacubitril/valsartan)
    Reporting group description
    		 Following randomization, patients received LCZ696 in titrated doses from level 1 up to level 3 (50, 100 and 200 mg twice daily). Patients were required to take a total of two pills, (one tablet from the LCZ696 pack and one capsule from Ramipril matching placebo pack) twice a day for the duration of the study. Patients randomized to LCZ who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization, received a valsartan bridge for one day. These patients received two doses of valsartan for 1 day in a blinded manner prior to beginning double-blind LCZ696 treatment.

    Reporting group title
    Ramipril
    Reporting group description
    		 Following randomization, patients received Ramipril in titrated doses from level 1 up to level 3 (1.25, 2.5 and 5 mg twice daily). Patients were required to take a total of two pills, (one capsule from the Ramipril pack and one tablet from LCZ696 matching placebo pack) twice a day for the duration of the study. Patients randomized to Ramipril who were previously treated with ACE inhibitors, receiving the last dose of that agent during the last 36 hours prior to randomization immediately started on double-blind ramipril; however, to maintain double blind/double dummy of the valsartan bridge, these patients received two doses of matching valsartan placebo for 1 day in a blinded manner prior to beginning double-blind LCZ696 placebo.

    Primary: Number of Participants with first CEC (clinical endpoint committee) confirmed primary composite endpoint

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    End point title
    		 Number of Participants with first CEC (clinical endpoint committee) confirmed primary composite endpoint
    End point description
    A confirmed composite endpoint includes cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient heart failure
    End point type
    Primary
    End point timeframe
    From randomization to first occurrence (up to approximately 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Count of Participants
        Primary Composite
    338
    373
        Cardiovascular (CV) Death
    168
    191
        First Heart Failure (HF) Hospitalization
    170
    195
        First Outpatient Heart Failure (HF)
    39
    57
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    Primary Composite
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1659
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9012
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7778
         upper limit
    		 1.0441
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    CV Death
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2031
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.874
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7104
         upper limit
    		 1.0754
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    First HF Hospitalization
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1679
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8653
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7044
         upper limit
    		 1.0629
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    First Outpatient HF
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0667
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.6831
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4546
         upper limit
    		 1.0266

    Secondary: Number of participants with a confirmed composite of CV death or HF hospitalization

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    End point title
    		 Number of participants with a confirmed composite of CV death or HF hospitalization
    End point description
    A confirmed composite endpoint for this outcome measure includes cardiovascular death or heart failure hospitalization.
    End point type
    Secondary
    End point timeframe
    Time from randomization to first occurrence (up to approximately 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Participants
    308
    335
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    CV death or HF hospitalization
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2507
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9133
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7824
         upper limit
    		 1.0662

    Secondary: Number of Participants with a confirmed composite of HF hospitalization or outpatient HF

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    End point title
    		 Number of Participants with a confirmed composite of HF hospitalization or outpatient HF
    End point description
    A confirmed composite endpoint includes first occurrence of heart failure hospitalization or outpatient heart failure
    End point type
    Secondary
    End point timeframe
    Time from randomization to first occurrence (approximately up to 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Participants
    201
    237
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    HF hospitalization or Outpatient HF
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0732
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8422
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6979
         upper limit
    		 1.0163

    Secondary: Number of Participants with a confirmed composite of CV death, non-fatal spontaneous myocardial infarction or non-fatal stroke

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    End point title
    		 Number of Participants with a confirmed composite of CV death, non-fatal spontaneous myocardial infarction or non-fatal stroke
    End point description
    A confirmed composite endpoint for this outcome measure includes cardiovascular death, non-fatal spontaneous myocardial infarction or non-fatal stroke
    End point type
    Secondary
    End point timeframe
    Time from randomization to first occurrence (approximately up to 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Participants
    315
    349
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    CV death, Non-fatal spontaneous MI or Non-fatal stroke
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1785
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.9007
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7734
         upper limit
    		 1.0489

    Secondary: Total Number of Confirmed Composite Endpoints

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    End point title
    		 Total Number of Confirmed Composite Endpoints
    End point description
    A confirmed composite endpoint includes cardiovascular death, heart failure hospitalization, non-fatal spontaneous MI hospitalization, and non-fatal stroke hospitalization
    End point type
    Secondary
    End point timeframe
    Time from randomization to end of study (approximately up to 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Events
    416
    455
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    Total Number of Confirmed Composite Endpoints
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0452
    Method
    		 Negative Binomial regression model
    Parameter type
    		 Rate Ratio
    Point estimate
    0.8361
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7018
         upper limit
    		 0.9961

    Secondary: All-cause mortality for Full Analysis Set (FAS)

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    End point title
    		 All-cause mortality for Full Analysis Set (FAS)
    End point description
    All-cause mortality defined as deaths related to Cardiovascular (CV) and non-CV events for patients in the Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Time from randomization to death (approximately up to 43 months)
    End point values
    		 LCZ696 (sacubitril/valsartan) Ramipril
    Number of subjects analysed
    2830
    2831
    Units: Participants
    213
    242
    Statistical analysis title
    		 LCZ696 vs Ramipril
    Statistical analysis description
    All-Cause Death
    Comparison groups
    LCZ696 (sacubitril/valsartan) v Ramipril
    Number of subjects included in analysis
    5661
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.1556
    Method
    		 Cox's Proportional Hazard Model
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.8751
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7279
         upper limit
    		 1.052

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to maximum duration of approximately 4 years.
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    Ramipril
    Reporting group description
    		 Ramipril

    Reporting group title
    LCZ696
    Reporting group description
    		 LCZ696

    Serious adverse events
    		 Ramipril LCZ696
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1126 / 2816 (39.99%)
    1146 / 2820 (40.64%)
         number of deaths (all causes)
    244
    220
         number of deaths resulting from adverse events
    5
    4
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenocarcinoma of colon
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma pancreas
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Anaplastic meningioma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell lymphoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    B-cell small lymphocytic lymphoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    B-cell unclassifiable lymphoma low grade
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    3 / 2816 (0.11%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign duodenal neoplasm
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder cancer
         subjects affected / exposed
    0 / 2816 (0.00%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Bladder transitional cell carcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bowen's disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer stage II
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Chronic myeloid leukaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic lymphocytic leukaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed
    5 / 2816 (0.18%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clear cell renal cell carcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colorectal cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colorectal adenocarcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometrial cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gallbladder adenosquamous carcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gallbladder cancer
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric neoplasm
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal carcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal neoplasm
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular carcinoma
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hepatic cancer
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Haemangioma of liver
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypopharyngeal cancer
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratoacanthoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal squamous cell carcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung adenocarcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung cancer metastatic
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Lung neoplasm
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Lung neoplasm malignant
         subjects affected / exposed
    5 / 2816 (0.18%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 3
    0 / 1
    Lung squamous cell carcinoma metastatic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphangiosis carcinomatosa
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malignant melanoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant peritoneal neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Malignant neoplasm of pleura
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Marginal zone lymphoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningioma
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases to liver
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastatic malignant melanoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastasis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Metastatic neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myeloproliferative neoplasm
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Monoclonal gammopathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myxoid liposarcoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm malignant
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasm progression
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Neuroendocrine carcinoma
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Non-small cell lung cancer
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oesophageal carcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Oropharyngeal cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 3
    Papillary cystadenoma lymphomatosum
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural mesothelioma malignant
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    3 / 2816 (0.11%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer metastatic
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Rectal adenocarcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cancer metastatic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of skin
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular neoplasm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous cell carcinoma of the parotid gland
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transitional cell cancer of the renal pelvis and ureter
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Transitional cell carcinoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tumour haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Vulval cancer
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm ruptured
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angiodysplasia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic aneurysm
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic dissection
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Aortic stenosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Arterial haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial occlusive disease
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial stenosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial thrombosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriosclerosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Circulatory collapse
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brachiocephalic arteriosclerosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Distributive shock
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolism arterial
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Extremity necrosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral artery aneurysm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    7 / 2816 (0.25%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    9 / 2816 (0.32%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive crisis
         subjects affected / exposed
    3 / 2816 (0.11%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive emergency
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertensive urgency
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    15 / 2816 (0.53%)
    37 / 2820 (1.31%)
         occurrences causally related to treatment / all
    7 / 16
    23 / 42
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iliac artery stenosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intermittent claudication
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic limb pain
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jugular vein thrombosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive shock
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthostatic hypotension
         subjects affected / exposed
    3 / 2816 (0.11%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    2 / 3
    3 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral arterial occlusive disease
         subjects affected / exposed
    9 / 2816 (0.32%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Peripheral artery aneurysm
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral vascular disorder
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral ischaemia
         subjects affected / exposed
    9 / 2816 (0.32%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phlebitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reperfusion injury
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subclavian artery occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombophlebitis superficial
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous aneurysm
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Cardiac pacemaker insertion
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transcatheter aortic valve implantation
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Hyperemesis gravidarum
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pre-eclampsia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Adverse event
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac death
         subjects affected / exposed
    4 / 2816 (0.14%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Chest discomfort
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthenia
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    31 / 2816 (1.10%)
    27 / 2820 (0.96%)
         occurrences causally related to treatment / all
    0 / 31
    2 / 27
         deaths causally related to treatment / all
    0 / 31
    2 / 27
    Chest pain
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Complication associated with device
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disease progression
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drowning
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General physical health deterioration
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Exercise tolerance decreased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fatigue
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Generalised oedema
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Necrosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Non-cardiac chest pain
         subjects affected / exposed
    66 / 2816 (2.34%)
    54 / 2820 (1.91%)
         occurrences causally related to treatment / all
    0 / 70
    0 / 64
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyp
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 2816 (0.11%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sudden cardiac death
         subjects affected / exposed
    14 / 2816 (0.50%)
    10 / 2820 (0.35%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 14
    0 / 10
    Sudden death
         subjects affected / exposed
    8 / 2816 (0.28%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 8
    0 / 9
    Surgical failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ulcer haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unevaluable event
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent stenosis
         subjects affected / exposed
    5 / 2816 (0.18%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular stent thrombosis
         subjects affected / exposed
    7 / 2816 (0.25%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 8
         deaths causally related to treatment / all
    0 / 1
    0 / 2
    Immune system disorders
    Anaphylactic shock
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contrast media allergy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Immobile
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcoholic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Imprisonment
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast necrosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast pain
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical polyp
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Female genital tract fistula
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hysterocele
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postmenopausal haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostatomegaly
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal oedema
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine polyp
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine prolapse
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    13 / 2816 (0.46%)
    19 / 2820 (0.67%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 3
    Acute respiratory failure
         subjects affected / exposed
    5 / 2816 (0.18%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
         deaths causally related to treatment / all
    0 / 3
    0 / 3
    Aspiration
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asphyxia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    13 / 2816 (0.46%)
    14 / 2820 (0.50%)
         occurrences causally related to treatment / all
    0 / 23
    0 / 19
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    28 / 2816 (0.99%)
    34 / 2820 (1.21%)
         occurrences causally related to treatment / all
    6 / 34
    0 / 38
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Cough
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea at rest
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea exertional
         subjects affected / exposed
    2 / 2816 (0.07%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Epistaxis
         subjects affected / exposed
    7 / 2816 (0.25%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    4 / 2816 (0.14%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Haemothorax
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrothorax
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung consolidation
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    6 / 2816 (0.21%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Painful respiration
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Orthopnoea
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary alveolar haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary artery thrombosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    5 / 2816 (0.18%)
    8 / 2820 (0.28%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary mass
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    13 / 2816 (0.46%)
    12 / 2820 (0.43%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Pulmonary pain
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheal stenosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sleep apnoea syndrome
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    11 / 2816 (0.39%)
    11 / 2820 (0.39%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    5 / 2816 (0.18%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Completed suicide
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Confusional state
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delirium
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disorientation
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Depression suicidal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hallucination
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality change due to a general medical condition
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status changes
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric decompensation
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Restlessness
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Product issues
    Device breakage
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device dislocation
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device defective
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device fastener issue
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device malfunction
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lead dislodgement
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute hepatic failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Autoimmune hepatitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stenosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bile duct stone
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary colic
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary cyst
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Biliary dilatation
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biliary dyspepsia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis acute
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis acute
         subjects affected / exposed
    6 / 2816 (0.21%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis
         subjects affected / exposed
    9 / 2816 (0.32%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug-induced liver injury
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic cirrhosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Hepatic mass
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic pain
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic hepatitis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice cholestatic
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Angiocardiogram
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anticoagulation drug level above therapeutic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy bladder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Biopsy prostate
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Blood glucose increased
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood glucose fluctuation
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac output decreased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood sodium decreased
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac ventriculogram
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulation test abnormal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ejection fraction abnormal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    12 / 2816 (0.43%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocardiogram QT prolonged
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glycosylated haemoglobin increased
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Heart rate decreased
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza B virus test positive
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    International normalised ratio increased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver function test increased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Occult blood positive
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal function test abnormal
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    SARS-CoV-2 test positive
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Scan myocardial perfusion abnormal
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminases increased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress echocardiogram
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Troponin increased
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight increased
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight decreased
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Acetabulum fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental exposure to product
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia postoperative
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anastomotic leak
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial bypass occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arterial injury
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac function disturbance postoperative
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac procedure complication
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac valve rupture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical vertebral fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    5 / 2816 (0.18%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery restenosis
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary bypass thrombosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary vascular graft occlusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniocerebral injury
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electric shock
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Fall
         subjects affected / exposed
    7 / 2816 (0.25%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 7
    2 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Femur fracture
         subjects affected / exposed
    4 / 2816 (0.14%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femoral neck fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip fracture
         subjects affected / exposed
    3 / 2816 (0.11%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional overdose
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaw fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar vertebral fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle injury
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumothorax traumatic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periprocedural myocardial infarction
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Post intensive care syndrome
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural discharge
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural complication
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural fistula
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematuria
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural myocardial infarction
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural urine leak
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prevertebral soft tissue swelling of cervical space
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural complication
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary contusion
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib fracture
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Radius fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin abrasion
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal compression fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic rupture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    4 / 2816 (0.14%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Toxicity to various agents
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thoracic vertebral fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic intracranial haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular pseudoaneurysm
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasoplegia syndrome
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Ventricular septal defect
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    13 / 2816 (0.46%)
    11 / 2820 (0.39%)
         occurrences causally related to treatment / all
    1 / 14
    0 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Acute left ventricular failure
         subjects affected / exposed
    6 / 2816 (0.21%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    1 / 6
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Acute myocardial infarction
         subjects affected / exposed
    95 / 2816 (3.37%)
    92 / 2820 (3.26%)
         occurrences causally related to treatment / all
    0 / 101
    1 / 100
         deaths causally related to treatment / all
    0 / 13
    0 / 8
    Adams-Stokes syndrome
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    84 / 2816 (2.98%)
    59 / 2820 (2.09%)
         occurrences causally related to treatment / all
    0 / 91
    0 / 69
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Angina unstable
         subjects affected / exposed
    76 / 2816 (2.70%)
    65 / 2820 (2.30%)
         occurrences causally related to treatment / all
    0 / 89
    0 / 70
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anginal equivalent
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve incompetence
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aortic valve disease
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    3 / 2816 (0.11%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 10
         deaths causally related to treatment / all
    0 / 3
    0 / 6
    Arteriosclerosis coronary artery
         subjects affected / exposed
    5 / 2816 (0.18%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    22 / 2816 (0.78%)
    30 / 2820 (1.06%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Atrial flutter
         subjects affected / exposed
    7 / 2816 (0.25%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial tachycardia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    1 / 2816 (0.04%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block complete
         subjects affected / exposed
    4 / 2816 (0.14%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block second degree
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    4 / 2816 (0.14%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac aneurysm
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    31 / 2816 (1.10%)
    24 / 2820 (0.85%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 27
         deaths causally related to treatment / all
    0 / 18
    0 / 13
    Cardiac asthma
         subjects affected / exposed
    3 / 2816 (0.11%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac discomfort
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorder
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    183 / 2816 (6.50%)
    149 / 2820 (5.28%)
         occurrences causally related to treatment / all
    4 / 249
    4 / 219
         deaths causally related to treatment / all
    1 / 18
    0 / 18
    Cardiac failure acute
         subjects affected / exposed
    22 / 2816 (0.78%)
    28 / 2820 (0.99%)
         occurrences causally related to treatment / all
    1 / 33
    0 / 33
         deaths causally related to treatment / all
    0 / 4
    0 / 3
    Cardiac failure chronic
         subjects affected / exposed
    8 / 2816 (0.28%)
    12 / 2820 (0.43%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 13
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    37 / 2816 (1.31%)
    27 / 2820 (0.96%)
         occurrences causally related to treatment / all
    2 / 54
    0 / 33
         deaths causally related to treatment / all
    1 / 7
    0 / 3
    Cardiac perforation
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac tamponade
         subjects affected / exposed
    6 / 2816 (0.21%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 0
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Cardiac ventricular thrombosis
         subjects affected / exposed
    8 / 2816 (0.28%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 4
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 2816 (0.04%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 1
    0 / 5
    Cardiogenic shock
         subjects affected / exposed
    12 / 2816 (0.43%)
    17 / 2820 (0.60%)
         occurrences causally related to treatment / all
    1 / 12
    0 / 18
         deaths causally related to treatment / all
    1 / 11
    0 / 6
    Cardiomyopathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiopulmonary failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiovascular disorder
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cardiovascular insufficiency
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Congestive cardiomyopathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic left ventricular failure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery insufficiency
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary artery disease
         subjects affected / exposed
    30 / 2816 (1.07%)
    23 / 2820 (0.82%)
         occurrences causally related to treatment / all
    0 / 30
    0 / 24
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Coronary artery occlusion
         subjects affected / exposed
    6 / 2816 (0.21%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery perforation
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    4 / 2816 (0.14%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dressler's syndrome
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis noninfective
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic cardiomyopathy
         subjects affected / exposed
    10 / 2816 (0.36%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Left ventricular dysfunction
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Left ventricular failure
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Microvascular coronary artery disease
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mitral valve incompetence
         subjects affected / exposed
    4 / 2816 (0.14%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial fibrosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    44 / 2816 (1.56%)
    51 / 2820 (1.81%)
         occurrences causally related to treatment / all
    1 / 47
    0 / 51
         deaths causally related to treatment / all
    0 / 9
    0 / 18
    Myocardial ischaemia
         subjects affected / exposed
    9 / 2816 (0.32%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Palpitations
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Papillary muscle disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paroxysmal atrioventricular block
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    6 / 2816 (0.21%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericarditis
         subjects affected / exposed
    8 / 2816 (0.28%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sinus bradycardia
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinus node dysfunction
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    3 / 2816 (0.11%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricle rupture
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Tachycardia
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular arrhythmia
         subjects affected / exposed
    5 / 2816 (0.18%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ventricular dysfunction
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular extrasystoles
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular fibrillation
         subjects affected / exposed
    11 / 2816 (0.39%)
    12 / 2820 (0.43%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    Ventricular remodelling
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachyarrhythmia
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    23 / 2816 (0.82%)
    19 / 2820 (0.67%)
         occurrences causally related to treatment / all
    0 / 26
    0 / 19
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Nervous system disorders
    Arachnoid cyst
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ataxia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain stem ischaemia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery occlusion
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Carotid artery stenosis
         subjects affected / exposed
    2 / 2816 (0.07%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebellar infarction
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    9 / 2816 (0.32%)
    8 / 2820 (0.28%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Cerebral hypoperfusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral ischaemia
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral venous sinus thrombosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    33 / 2816 (1.17%)
    32 / 2820 (1.13%)
         occurrences causally related to treatment / all
    0 / 38
    0 / 36
         deaths causally related to treatment / all
    0 / 3
    0 / 5
    Cerebrovascular insufficiency
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical radiculopathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Disturbance in attention
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Demyelinating polyneuropathy
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Dizziness
         subjects affected / exposed
    3 / 2816 (0.11%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    1 / 3
    3 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dizziness postural
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysarthria
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Embolic stroke
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage intracranial
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhagic stroke
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    0 / 2
    Haemorrhagic transformation stroke
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hemianopia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoaesthesia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hemiparesis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemic coma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic-ischaemic encephalopathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Irregular sleep wake rhythm disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ischaemic stroke
         subjects affected / exposed
    15 / 2816 (0.53%)
    12 / 2820 (0.43%)
         occurrences causally related to treatment / all
    0 / 15
    1 / 12
         deaths causally related to treatment / all
    0 / 4
    0 / 0
    Lacunar stroke
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lacunar infarction
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic encephalopathy
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Moyamoya disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    0 / 2820 (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
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyneuropathy
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post stroke seizure
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Presyncope
         subjects affected / exposed
    4 / 2816 (0.14%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 4
    2 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychogenic seizure
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    6 / 2816 (0.21%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Spinal cord haemorrhage
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status epilepticus
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Subdural hygroma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertebrobasilar insufficiency
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    30 / 2816 (1.07%)
    36 / 2820 (1.28%)
         occurrences causally related to treatment / all
    4 / 31
    9 / 43
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    10 / 2816 (0.36%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia macrocytic
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    23 / 2816 (0.82%)
    30 / 2820 (1.06%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 31
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Blood loss anaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile neutropenia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocoagulable state
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    4 / 2816 (0.14%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenopathy
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microcytic anaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Splenic haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo positional
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vertigo
         subjects affected / exposed
    5 / 2816 (0.18%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular disorder
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Arteriosclerotic retinopathy
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blindness unilateral
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye oedema
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cataract
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diplopia
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glaucoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye swelling
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iridocyclitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraocular haematoma
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Keratitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Open angle glaucoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital oedema
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinal detachment
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vitreous haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhegmatogenous retinal detachment
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Visual impairment
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal mass
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal hernia obstructive
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain
         subjects affected / exposed
    5 / 2816 (0.18%)
    8 / 2820 (0.28%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Abdominal pain upper
         subjects affected / exposed
    5 / 2816 (0.18%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    1 / 5
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Ascites
         subjects affected / exposed
    4 / 2816 (0.14%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Acute abdomen
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Colitis ischaemic
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crohn's disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dental cyst
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    8 / 2816 (0.28%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 4
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular perforation
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum intestinal haemorrhagic
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Duodenal ulcer haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         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 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Faeces discoloured
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
         subjects affected / exposed
    5 / 2816 (0.18%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis erosive
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis haemorrhagic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    12 / 2816 (0.43%)
    15 / 2820 (0.53%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 16
         deaths causally related to treatment / all
    0 / 2
    0 / 1
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 2816 (0.07%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoidal haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids thrombosed
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ileus paralytic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    2 / 2816 (0.07%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal ischaemia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal pseudo-obstruction
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine polyp
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lip swelling
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mechanical ileus
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malabsorption
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Melaena
         subjects affected / exposed
    1 / 2816 (0.04%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth swelling
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mesenteric arterial occlusion
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 2816 (0.04%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    5 / 2816 (0.18%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pancreatitis
         subjects affected / exposed
    3 / 2816 (0.11%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal achalasia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritoneal adhesions
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peptic ulcer
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    6 / 2816 (0.21%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal polyp
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal haemorrhage
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small intestinal obstruction
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    5 / 2816 (0.18%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    5 / 2816 (0.18%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    5 / 5
    4 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decubitus ulcer
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    3 / 2816 (0.11%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic wound
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pruritus
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperhidrosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Symmetrical drug-related intertriginous and flexural exanthema
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    30 / 2816 (1.07%)
    37 / 2820 (1.31%)
         occurrences causally related to treatment / all
    12 / 36
    12 / 40
         deaths causally related to treatment / all
    0 / 0
    2 / 3
    Anuria
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Azotaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder tamponade
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Calculus bladder
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysuria
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    7 / 2816 (0.25%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    End stage renal disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhage urinary tract
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal colic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    8 / 2816 (0.28%)
    10 / 2820 (0.35%)
         occurrences causally related to treatment / all
    2 / 8
    2 / 11
         deaths causally related to treatment / all
    0 / 1
    0 / 4
    Renal haematoma
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    6 / 2816 (0.21%)
    14 / 2820 (0.50%)
         occurrences causally related to treatment / all
    3 / 6
    7 / 15
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Ureteric obstruction
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral obstruction
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary bladder polyp
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    1 / 2816 (0.04%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal mass
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    0 / 2816 (0.00%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bursitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Back disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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
    3 / 2816 (0.11%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deformity thorax
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Costochondritis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chondrocalcinosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gouty arthritis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enthesopathy
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fistula discharge
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemarthrosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc disorder
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protrusion
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscular weakness
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mobility decreased
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal chest pain
         subjects affected / exposed
    5 / 2816 (0.18%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal pain
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteitis
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    6 / 2816 (0.21%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteochondrosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoporotic fracture
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pathological fracture
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polyarthritis
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periostosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polymyalgia rheumatica
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudarthrosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess jaw
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess oral
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    3 / 2816 (0.11%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial abdominal infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    6 / 2816 (0.21%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bone abscess
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    16 / 2816 (0.57%)
    13 / 2820 (0.46%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 13
         deaths causally related to treatment / all
    0 / 4
    0 / 5
    COVID-19 pneumonia
         subjects affected / exposed
    8 / 2816 (0.28%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 7
         deaths causally related to treatment / all
    0 / 4
    0 / 2
    Carbuncle
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    5 / 2816 (0.18%)
    11 / 2820 (0.39%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangitis infective
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile infection
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus infection
         subjects affected / exposed
    3 / 2816 (0.11%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Cystitis
         subjects affected / exposed
    2 / 2816 (0.07%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic gangrene
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Endocarditis
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Empyema
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocarditis staphylococcal
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    5 / 2816 (0.18%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia sepsis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fournier's gangrene
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gangrene
         subjects affected / exposed
    5 / 2816 (0.18%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gas gangrene
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    7 / 2816 (0.25%)
    11 / 2820 (0.39%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Genital herpes
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Helicobacter duodenal ulcer
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incision site abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected dermal cyst
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    3 / 2816 (0.11%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Labyrinthitis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 2816 (0.07%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenic sepsis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral candidiasis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    4 / 2820 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Orchitis
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis acute
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis externa
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         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 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parotitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pharyngeal abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    73 / 2816 (2.59%)
    61 / 2820 (2.16%)
         occurrences causally related to treatment / all
    0 / 79
    0 / 65
         deaths causally related to treatment / all
    0 / 8
    0 / 7
    Pneumonia bacterial
         subjects affected / exposed
    0 / 2816 (0.00%)
    3 / 2820 (0.11%)
         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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative wound infection
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural sepsis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 2816 (0.04%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    6 / 2816 (0.21%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scrotal abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    13 / 2816 (0.46%)
    19 / 2820 (0.67%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 24
         deaths causally related to treatment / all
    0 / 7
    0 / 7
    Septic shock
         subjects affected / exposed
    8 / 2816 (0.28%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 9
         deaths causally related to treatment / all
    0 / 4
    0 / 4
    Skin infection
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (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
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth abscess
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected COVID-19
         subjects affected / exposed
    0 / 2816 (0.00%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    16 / 2816 (0.57%)
    28 / 2820 (0.99%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 33
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vestibular neuronitis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    2 / 2816 (0.07%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral labyrinthitis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral sepsis
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound abscess
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    3 / 2816 (0.11%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection bacterial
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Acidosis hyperchloraemic
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    10 / 2816 (0.36%)
    9 / 2820 (0.32%)
         occurrences causally related to treatment / all
    0 / 10
    1 / 9
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cachexia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Diabetes mellitus inadequate control
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic ketoacidosis
         subjects affected / exposed
    2 / 2816 (0.07%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic metabolic decompensation
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetes mellitus
         subjects affected / exposed
    3 / 2816 (0.11%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Euglycaemic diabetic ketoacidosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    2 / 2816 (0.07%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    2 / 2816 (0.07%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypercalcaemia
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food intolerance
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    4 / 2816 (0.14%)
    15 / 2820 (0.53%)
         occurrences causally related to treatment / all
    2 / 4
    12 / 20
         deaths causally related to treatment / all
    1 / 1
    0 / 0
    Hypertriglyceridaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    4 / 2816 (0.14%)
    6 / 2820 (0.21%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    3 / 2816 (0.11%)
    5 / 2820 (0.18%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    10 / 2816 (0.36%)
    7 / 2820 (0.25%)
         occurrences causally related to treatment / all
    1 / 11
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    4 / 2816 (0.14%)
    3 / 2820 (0.11%)
         occurrences causally related to treatment / all
    1 / 4
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophosphataemia
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 2816 (0.04%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lactic acidosis
         subjects affected / exposed
    2 / 2816 (0.07%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ketoacidosis
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudohyponatraemia
         subjects affected / exposed
    0 / 2816 (0.00%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 2 diabetes mellitus
         subjects affected / exposed
    4 / 2816 (0.14%)
    0 / 2820 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obesity
         subjects affected / exposed
    1 / 2816 (0.04%)
    1 / 2820 (0.04%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 2816 (0.04%)
    2 / 2820 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Ramipril LCZ696
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1770 / 2816 (62.86%)
    1769 / 2820 (62.73%)
    Vascular disorders
    Hypotension
         subjects affected / exposed
    288 / 2816 (10.23%)
    447 / 2820 (15.85%)
         occurrences all number
    339
    537
    Hypertension
         subjects affected / exposed
    143 / 2816 (5.08%)
    96 / 2820 (3.40%)
         occurrences all number
    158
    105
    Orthostatic hypotension
         subjects affected / exposed
    32 / 2816 (1.14%)
    66 / 2820 (2.34%)
         occurrences all number
    34
    69
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    136 / 2816 (4.83%)
    125 / 2820 (4.43%)
         occurrences all number
    147
    131
    Asthenia
         subjects affected / exposed
    58 / 2816 (2.06%)
    67 / 2820 (2.38%)
         occurrences all number
    67
    69
    Non-cardiac chest pain
         subjects affected / exposed
    156 / 2816 (5.54%)
    183 / 2820 (6.49%)
         occurrences all number
    187
    222
    Oedema peripheral
         subjects affected / exposed
    125 / 2816 (4.44%)
    122 / 2820 (4.33%)
         occurrences all number
    150
    140
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    359 / 2816 (12.75%)
    239 / 2820 (8.48%)
         occurrences all number
    398
    278
    Dyspnoea
         subjects affected / exposed
    251 / 2816 (8.91%)
    185 / 2820 (6.56%)
         occurrences all number
    285
    216
    Dyspnoea exertional
         subjects affected / exposed
    51 / 2816 (1.81%)
    63 / 2820 (2.23%)
         occurrences all number
    55
    71
    Epistaxis
         subjects affected / exposed
    79 / 2816 (2.81%)
    60 / 2820 (2.13%)
         occurrences all number
    91
    69
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    74 / 2816 (2.63%)
    53 / 2820 (1.88%)
         occurrences all number
    78
    54
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    58 / 2816 (2.06%)
    51 / 2820 (1.81%)
         occurrences all number
    67
    59
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    87 / 2816 (3.09%)
    85 / 2820 (3.01%)
         occurrences all number
    99
    92
    Angina pectoris
         subjects affected / exposed
    140 / 2816 (4.97%)
    125 / 2820 (4.43%)
         occurrences all number
    162
    146
    Cardiac failure
         subjects affected / exposed
    150 / 2816 (5.33%)
    128 / 2820 (4.54%)
         occurrences all number
    177
    143
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    241 / 2816 (8.56%)
    280 / 2820 (9.93%)
         occurrences all number
    273
    334
    Headache
         subjects affected / exposed
    69 / 2816 (2.45%)
    78 / 2820 (2.77%)
         occurrences all number
    74
    86
    Syncope
         subjects affected / exposed
    57 / 2816 (2.02%)
    52 / 2820 (1.84%)
         occurrences all number
    60
    56
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    123 / 2816 (4.37%)
    130 / 2820 (4.61%)
         occurrences all number
    125
    136
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    57 / 2816 (2.02%)
    42 / 2820 (1.49%)
         occurrences all number
    60
    43
    Constipation
         subjects affected / exposed
    99 / 2816 (3.52%)
    70 / 2820 (2.48%)
         occurrences all number
    104
    76
    Diarrhoea
         subjects affected / exposed
    179 / 2816 (6.36%)
    227 / 2820 (8.05%)
         occurrences all number
    204
    253
    Nausea
         subjects affected / exposed
    101 / 2816 (3.59%)
    93 / 2820 (3.30%)
         occurrences all number
    109
    99
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    59 / 2816 (2.10%)
    72 / 2820 (2.55%)
         occurrences all number
    64
    80
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    50 / 2816 (1.78%)
    58 / 2820 (2.06%)
         occurrences all number
    54
    62
    Renal impairment
         subjects affected / exposed
    129 / 2816 (4.58%)
    124 / 2820 (4.40%)
         occurrences all number
    142
    144
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    103 / 2816 (3.66%)
    114 / 2820 (4.04%)
         occurrences all number
    120
    125
    Back pain
         subjects affected / exposed
    103 / 2816 (3.66%)
    72 / 2820 (2.55%)
         occurrences all number
    110
    72
    Myalgia
         subjects affected / exposed
    80 / 2816 (2.84%)
    70 / 2820 (2.48%)
         occurrences all number
    86
    76
    Pain in extremity
         subjects affected / exposed
    95 / 2816 (3.37%)
    88 / 2820 (3.12%)
         occurrences all number
    103
    97
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    66 / 2816 (2.34%)
    58 / 2820 (2.06%)
         occurrences all number
    71
    63
    Nasopharyngitis
         subjects affected / exposed
    72 / 2816 (2.56%)
    107 / 2820 (3.79%)
         occurrences all number
    88
    130
    Upper respiratory tract infection
         subjects affected / exposed
    57 / 2816 (2.02%)
    54 / 2820 (1.91%)
         occurrences all number
    61
    61
    Urinary tract infection
         subjects affected / exposed
    95 / 2816 (3.37%)
    97 / 2820 (3.44%)
         occurrences all number
    106
    114
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    249 / 2816 (8.84%)
    256 / 2820 (9.08%)
         occurrences all number
    331
    348
    Hypokalaemia
         subjects affected / exposed
    56 / 2816 (1.99%)
    76 / 2820 (2.70%)
         occurrences all number
    61
    84

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2016
    The purpose of this amendment was to refine the recommendations for alternative treatment to ensure sufficient renin angiotensin system (RAS) blockade in the event a patient needs to discontinue the study drug due to intolerable adverse events.
    25 Apr 2017
    The purpose of this amendment was to add an echocardiogrpahic substudy to the protocol. The amendment also removed the targeted adverse event data collection, and provided additional guidance for co-administering LCZ696 with atorvastatin or other statins.
    01 May 2019
    The purpose of this amendment was to increase the sample size from 4,650 to 5,650 and adjust the assumption for the primary composite endpoint events of cardiovascular (CV) death, heart failure (HF) hospitalization, or outpatient HF treatment effect from 18% to 19%.
    06 Aug 2020
    The purpose of this amendment was to add a second interim analysis in response to the COVID-19 pandemic with the stopping boundary for the primary endpoint at one-sided alpha of 0.005.

    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.
    In this study there were 25 patients who did not take study treatment after randomization, and thus were not included in the safety set.
    For support, Contact us.
    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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